Cataract
Conditions
Keywords
Cataract, IOL, Modular IOL, IOL exchange
Brief summary
The main objectives of this feasibility study were: * To demonstrate the feasibility of HARMONI Modular Intraocular Lens (HMIOL) implantation and assembly in subjects undergoing cataract surgery (All HMIOL Cohort), and * To demonstrate the feasibility of the HMIOL optic component exchange procedure (performed 3 months following primary cataract extraction) (Cohort 2).
Detailed description
Eligible subjects with bilateral cataracts underwent cataract extraction and IOL implantation using phacoemulsification. The study eye was implanted with the investigational device (All HMIOL Cohort). The fellow eye was treated with a commercially available intraocular lens (IOL) per standard of care procedure. At the scheduled Month 3 post-operative visit, subjects who did not opt to pursue an optic exchange procedure in the study eye were enrolled into subgroup Cohort 1 and followed for an additional 6 months. The total duration of participation for Cohort 1 was up to 15 months, which included a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. At the scheduled Month 3 post-operative visit, subjects who elected to pursue an optic exchange procedure in the study eye were enrolled into subgroup Cohort 2 and followed for an additional 12 months. The total duration of participation for Cohort 2 was up to 18 months, which included a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period. Alcon Research, LLC, acquired ClarVista Medical in 2017. This study was designed and conducted by ClarVista Medical, Inc., to evaluate the safety and effectiveness of the HMIOL. The study results were collected, analyzed, and provided by ClarVista Medical, Inc. to Alcon Research, LLC.
Interventions
Two-component system consisting of a base and a separate optic that allows for an intraoperative exchange of the optic only without direct manipulation of the capsular bag
DEVICECommercially Available Intraocular Lens
IOL per investigator's standard of care
PROCEDUREOptic exchange
Removal of one optic and replacement with another for the purpose of improving refractive outcomes
Sponsors
ClarVista Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be able to understand and provide informed consent * Must be willing and able to return for scheduled treatment and follow-up examinations for up to 15 month study duration * Planned bilateral removal of visually significant bilateral cataracts * Best-corrected distance visual acuity (BCDVA) projected to be better than 20/32 after IOL implantation in both eyes * Preoperative bilateral BCDVA of 20/40 or worse * Both eyes must have corneal astigmatism ≤ 1.50 diopter (D) * Women must be post-menopausal ≥1 year or surgically sterilized, or a pregnancy screen must be performed prior to the study and a reliable form of contraception, approved by the investigator, must be maintained during the study * Dilated pupil size equal to or greater than 6 millimeters (mm) in primary study eye * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Participation in any other drug or device clinical trial within 30 days prior to enrolling in this study and/or during study participation * History of any intraocular or corneal surgery in either eye (including refractive) * History of any clinically significant retinal pathology or ocular diagnosis in either eye * History of any ocular conditions which could affect the stability of the IOL * Uncontrolled glaucoma in either eye * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - All HMIOL Cohort | Month 1 postoperative, Month 3 postoperative | Visual acuity (VA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS)-Fast method under well-lit conditions at a distance of 4 meters (m) with the correction obtained from manifest refraction testing. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. |
| Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 1 | Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. |
| Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 2 | Month 1 postoperative, Month 3 postoperative, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Month 1 postoperative and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned |
| Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Fellow Eye | Month 1 postoperative, Month 3 postoperative, Month 12 postoperative | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. |
| Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - All HMIOL Cohort | Week 1 postoperative, Month 1 postoperative, Month 3 postoperative | A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. |
| Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 1 | Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative | A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. |
| Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2 | Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange | A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Week 1 postoperative, Month 1 postoperative, and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. |
| Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Fellow Eye | Month 1 postoperative, Month 3 postoperative, Month 12 postoperative | A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). This analysis was prespecified for the fellow eye. No formal statistical hypothesis testing was planned. |
| Mean BCDVA (Letters Read) by Study Visit - All HMIOL Cohort | Day -90 to Day -1 preoperative, Month 1 postoperative, Month 3 postoperative | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. |
| Mean BCDVA (Letters Read) by Study Visit - Cohort 1 | Day -90 to -1 preoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. |
| Mean BCDVA (Letters Read) by Study Visit - Cohort 2 | Day -90 to -1 preoperative, Month 1 postoperative, Month 3 postoperative, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in letters read correctly. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Month 1 postoperative and Month 3 postoperative visits were pre-optic exchange.This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. |
| Mean BCDVA (Letters Read) by Study Visit - Fellow Eye | Day -90 to -1 preoperative, Month 1 postoperative, Month 3 postoperative, Month 12 postoperative | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was rrecorded in letters read correctly. This analysis was prespecified for the fellow eye. No formal statistical hypothesis testing was planned. |
| Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - All HMIOL Cohort | Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. |
| Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 1 | Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. |
| Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 2 | Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Day 1 post-optic exchange, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exch | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned. |
| Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Fellow Eye | Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. This analysis was prespecified for the fellow eye. No formal statistical hypothesis testing was planned. |
| Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2 | Day 1 post-optic exchange, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange | VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye, Cohort 2 only. No formal statistical hypothesis testing was planned. |
| Mesopic Best Corrected Distance Visual Acuity (mBCDVA) (With and Without Glare) (Letters Read) at Study Visit - All HMIOL Cohort | Month 3 postoperative | VA was assessed using the ETDRS-Fast method under mesopic (dimly lit) conditions at a distance of 4 m with the correction obtained from manifest refraction testing. Testing was performed with and without glare. Chart luminance was set to 3 cd/m2. mBCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye, All HMIOL Cohort only. No formal statistical hypothesis testing was planned. |
Countries
New Zealand, Philippines
Participant flow
Recruitment details
Subjects were recruited from 3 investigational sites located in the Philippines (2) and New Zealand (1).
Pre-assignment details
Of the 217 enrolled, 101 subjects did exit the study prior to implantation, and 2 subjects failed implantation of Harmoni Modular Intraocular Lens (HMIOL). This reporting group includes all subjects with successful HMIOL implantation (114) by subgroup (Cohort 1 and Cohort 2).
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 HMIOL implantation with no optic exchange | 47 |
| Cohort 2 HMIOL implantation with optic exchange | 65 |
| Total | 112 |
Baseline characteristics
| Characteristic | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Age, Continuous | 66.8 years STANDARD_DEVIATION 6.9 | 65.4 years STANDARD_DEVIATION 6.7 | 66.0 years STANDARD_DEVIATION 6.8 |
| Race/Ethnicity, Customized Asian | 28 Participants | 52 Participants | 80 Participants |
| Race/Ethnicity, Customized Black | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Caucasian | 19 Participants | 11 Participants | 30 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Female | 31 Participants | 40 Participants | 71 Participants |
| Sex: Female, Male Male | 16 Participants | 25 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 65 | 0 / 65 | 0 / 114 | 0 / 114 |
| other Total, other adverse events | 2 / 51 | 1 / 65 | 6 / 65 | 5 / 114 | 0 / 114 |
| serious Total, serious adverse events | 2 / 51 | 2 / 65 | 0 / 65 | 2 / 114 | 4 / 114 |
Outcome results
Primary
Mean BCDVA (Letters Read) by Study Visit - All HMIOL Cohort
VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.
Time frame: Day -90 to Day -1 preoperative, Month 1 postoperative, Month 3 postoperative
Population: Per Protocol Population, with available data at the visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All HMIOL Cohort | Mean BCDVA (Letters Read) by Study Visit - All HMIOL Cohort | Day -90 to Day -1 preoperative | 75.2 letters | Standard Deviation 14.2 |
| All HMIOL Cohort | Mean BCDVA (Letters Read) by Study Visit - All HMIOL Cohort | Month 1 postoperative | 84.6 letters | Standard Deviation 4.5 |
| All HMIOL Cohort | Mean BCDVA (Letters Read) by Study Visit - All HMIOL Cohort | Month 3 postoperative | 85.4 letters | Standard Deviation 3.8 |
Primary
Mean BCDVA (Letters Read) by Study Visit - Cohort 1
VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.
Time frame: Day -90 to -1 preoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative
Population: Per Protocol Population, with available data at the visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All HMIOL Cohort | Mean BCDVA (Letters Read) by Study Visit - Cohort 1 | Day -90 to -1 preoperative | 79.9 letters | Standard Deviation 9.4 |
| All HMIOL Cohort | Mean BCDVA (Letters Read) by Study Visit - Cohort 1 | Month 1 postoperative | 85.8 letters | Standard Deviation 3.6 |
| All HMIOL Cohort | Mean BCDVA (Letters Read) by Study Visit - Cohort 1 | Month 3 postoperative | 86.7 letters | Standard Deviation 3.5 |
| All HMIOL Cohort | Mean BCDVA (Letters Read) by Study Visit - Cohort 1 | Month 6 postoperative | 86.2 letters | Standard Deviation 3.9 |
| All HMIOL Cohort | Mean BCDVA (Letters Read) by Study Visit - Cohort 1 | Month 12 postoperative | 86.2 letters | Standard Deviation 4.5 |
Primary
Mean BCDVA (Letters Read) by Study Visit - Cohort 2
VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in letters read correctly. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Month 1 postoperative and Month 3 postoperative visits were pre-optic exchange.This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.
Time frame: Day -90 to -1 preoperative, Month 1 postoperative, Month 3 postoperative, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange
Population: Per Protocol Population, with available data at the visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All HMIOL Cohort | Mean BCDVA (Letters Read) by Study Visit - Cohort 2 | Day -90 to -1 preoperative | 71.8 letters | Standard Deviation 16.1 |
| All HMIOL Cohort | Mean BCDVA (Letters Read) by Study Visit - Cohort 2 | Month 1 postoperative | 83.7 letters | Standard Deviation 4.9 |
| All HMIOL Cohort | Mean BCDVA (Letters Read) by Study Visit - Cohort 2 | Month 3 postoperative | 84.4 letters | Standard Deviation 3.8 |
| All HMIOL Cohort | Mean BCDVA (Letters Read) by Study Visit - Cohort 2 | Week 1 post-optic exchange | 84.5 letters | Standard Deviation 4.4 |
| All HMIOL Cohort | Mean BCDVA (Letters Read) by Study Visit - Cohort 2 | Month 1 post-optic exchange | 85.1 letters | Standard Deviation 4 |
| All HMIOL Cohort | Mean BCDVA (Letters Read) by Study Visit - Cohort 2 | Month 3 post-optic exchange | 85.2 letters | Standard Deviation 4 |
| All HMIOL Cohort | Mean BCDVA (Letters Read) by Study Visit - Cohort 2 | Month 6 post-optic exchange | 85.6 letters | Standard Deviation 3.5 |
| All HMIOL Cohort | Mean BCDVA (Letters Read) by Study Visit - Cohort 2 | Month 12 post-optic exchange | 83.5 letters | Standard Deviation 9.9 |
Primary
Mean BCDVA (Letters Read) by Study Visit - Fellow Eye
VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was rrecorded in letters read correctly. This analysis was prespecified for the fellow eye. No formal statistical hypothesis testing was planned.
Time frame: Day -90 to -1 preoperative, Month 1 postoperative, Month 3 postoperative, Month 12 postoperative
Population: Per Protocol Population, with available data at the visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All HMIOL Cohort | Mean BCDVA (Letters Read) by Study Visit - Fellow Eye | Day -90 to -1 preoperative | 74.5 letters | Standard Deviation 17.9 |
| All HMIOL Cohort | Mean BCDVA (Letters Read) by Study Visit - Fellow Eye | Month 1 postoperative | 86.3 letters | Standard Deviation 4 |
| All HMIOL Cohort | Mean BCDVA (Letters Read) by Study Visit - Fellow Eye | Month 3 postoperative | 86.9 letters | Standard Deviation 3.4 |
| All HMIOL Cohort | Mean BCDVA (Letters Read) by Study Visit - Fellow Eye | Month 12 postoperative | 86.9 letters | Standard Deviation 3.5 |
Primary
Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - All HMIOL Cohort
VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.
Time frame: Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
Population: Per Protocol Population, with available data at the visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All HMIOL Cohort | Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - All HMIOL Cohort | Day 1 postoperative | 71.5 letters | Standard Deviation 11 |
| All HMIOL Cohort | Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - All HMIOL Cohort | Week 1 postoperative | 70.4 letters | Standard Deviation 10.1 |
| All HMIOL Cohort | Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - All HMIOL Cohort | Month 1 postoperative | 70.6 letters | Standard Deviation 10.2 |
| All HMIOL Cohort | Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - All HMIOL Cohort | Month 3 postoperative | 73.4 letters | Standard Deviation 9.3 |
Primary
Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 1
VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.
Time frame: Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative
Population: Per Protocol Population, with available data at the visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All HMIOL Cohort | Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 1 | Month 12 postoperative | 77.9 letters | Standard Deviation 6.9 |
| All HMIOL Cohort | Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 1 | Day 1 postoperative | 74.8 letters | Standard Deviation 10.2 |
| All HMIOL Cohort | Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 1 | Week 1 postoperative | 73.7 letters | Standard Deviation 9.2 |
| All HMIOL Cohort | Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 1 | Month 1 postoperative | 75.4 letters | Standard Deviation 8.3 |
| All HMIOL Cohort | Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 1 | Month 3 postoperative | 77.1 letters | Standard Deviation 8.2 |
| All HMIOL Cohort | Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 1 | Month 6 postoperative | 78.1 letters | Standard Deviation 7.3 |
Primary
Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 2
VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.
Time frame: Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Day 1 post-optic exchange, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exch
Population: Per Protocol Population, with available data at the visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All HMIOL Cohort | Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 2 | Day 1 postoperative | 69.1 letters | Standard Deviation 10.9 |
| All HMIOL Cohort | Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 2 | Week 1 postoperative | 68.1 letters | Standard Deviation 10.2 |
| All HMIOL Cohort | Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 2 | Month 1 postoperative | 67.2 letters | Standard Deviation 10.2 |
| All HMIOL Cohort | Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 2 | Month 3 postoperative | 70.7 letters | Standard Deviation 9.2 |
| All HMIOL Cohort | Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 2 | Day 1 post-optic exchange | 76.8 letters | Standard Deviation 13.4 |
| All HMIOL Cohort | Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 2 | Week 1 post-optic exchange | 79.8 letters | Standard Deviation 6 |
| All HMIOL Cohort | Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 2 | Month 1 post-optic exchange | 80.7 letters | Standard Deviation 6.4 |
| All HMIOL Cohort | Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 2 | Month 3 post-optic exchange | 81.1 letters | Standard Deviation 5.5 |
| All HMIOL Cohort | Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 2 | Month 6 post-optic exchange | 81.2 letters | Standard Deviation 5.4 |
| All HMIOL Cohort | Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 2 | Month 12 post-optic exchange | 78.2 letters | Standard Deviation 13.4 |
Primary
Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Fellow Eye
VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. This analysis was prespecified for the fellow eye. No formal statistical hypothesis testing was planned.
Time frame: Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative
Population: Per Protocol Population, with available data at the visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All HMIOL Cohort | Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Fellow Eye | Day 1 postoperative | 80.6 letters | Standard Deviation 8 |
| All HMIOL Cohort | Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Fellow Eye | Week 1 postoperative | 81.3 letters | Standard Deviation 6.4 |
| All HMIOL Cohort | Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Fellow Eye | Month 1 postoperative | 81.3 letters | Standard Deviation 5.8 |
| All HMIOL Cohort | Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Fellow Eye | Month 3 postoperative | 82.4 letters | Standard Deviation 5.4 |
| All HMIOL Cohort | Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Fellow Eye | Month 6 postoperative | 83.0 letters | Standard Deviation 5 |
| All HMIOL Cohort | Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Fellow Eye | Month 12 postoperative | 82.1 letters | Standard Deviation 5.5 |
Primary
Mesopic Best Corrected Distance Visual Acuity (mBCDVA) (With and Without Glare) (Letters Read) at Study Visit - All HMIOL Cohort
VA was assessed using the ETDRS-Fast method under mesopic (dimly lit) conditions at a distance of 4 m with the correction obtained from manifest refraction testing. Testing was performed with and without glare. Chart luminance was set to 3 cd/m2. mBCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye, All HMIOL Cohort only. No formal statistical hypothesis testing was planned.
Time frame: Month 3 postoperative
Population: Per Protocol Population, with available data at the visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All HMIOL Cohort | Mesopic Best Corrected Distance Visual Acuity (mBCDVA) (With and Without Glare) (Letters Read) at Study Visit - All HMIOL Cohort | With glare | 81.0 letters | Standard Deviation 4.9 |
| All HMIOL Cohort | Mesopic Best Corrected Distance Visual Acuity (mBCDVA) (With and Without Glare) (Letters Read) at Study Visit - All HMIOL Cohort | Without glare | 81.1 letters | Standard Deviation 5.6 |
Primary
Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - All HMIOL Cohort
Visual acuity (VA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS)-Fast method under well-lit conditions at a distance of 4 meters (m) with the correction obtained from manifest refraction testing. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.
Time frame: Month 1 postoperative, Month 3 postoperative
Population: Per Protocol Population, with available data at the visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All HMIOL Cohort | Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - All HMIOL Cohort | Month 1 postoperative | 99.1 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - All HMIOL Cohort | Month 3 postoperative | 100.0 percentage of eyes |
Primary
Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 1
VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.
Time frame: Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative
Population: Per Protocol Population, with available data at the visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All HMIOL Cohort | Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 1 | Month 1 postoperative | 100.0 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 1 | Month 3 postoperative | 100.0 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 1 | Month 6 postoperative | 100.0 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 1 | Month 12 postoperative | 100.0 percentage of eyes |
Primary
Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 2
VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Month 1 postoperative and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned
Time frame: Month 1 postoperative, Month 3 postoperative, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange
Population: Per Protocol Population, with available data at the visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All HMIOL Cohort | Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 2 | Month 1 postoperative | 98.5 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 2 | Month 3 postoperative | 100 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 2 | Week 1 post-optic exchange | 100 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 2 | Month 1 post-optic exchange | 100 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 2 | Month 3 post-optic exchange | 100 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 2 | Month 6 post-optic exchange | 100 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 2 | Month 12 post-optic exchange | 96.8 percentage of eyes |
Primary
Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Fellow Eye
VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.
Time frame: Month 1 postoperative, Month 3 postoperative, Month 12 postoperative
Population: Per Protocol Population, with available data at the visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All HMIOL Cohort | Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Fellow Eye | Month 1 postoperative | 100.0 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Fellow Eye | Month 3 postoperative | 100.0 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Fellow Eye | Month 12 postoperative | 100.0 percentage of eyes |
Primary
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - All HMIOL Cohort
A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.
Time frame: Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
Population: Per Protocol Population, with available data at the visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - All HMIOL Cohort | Week 1 postoperative: Within ± 0.5 D of Target | 33.9 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - All HMIOL Cohort | Week 1 postoperative: Within ± 1.0 D of Target | 70.6 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - All HMIOL Cohort | Month 1 postoperative: Within ± 0.5 D of Target | 26.8 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - All HMIOL Cohort | Month 1 postoperative: Within ± 1.0 D of Target | 61.6 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - All HMIOL Cohort | Month 3 postoperative: Within ± 0.5 D of Target | 19.6 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - All HMIOL Cohort | Month 3 postoperative: Within ± 1.0 D of Target | 52.7 percentage of eyes |
Primary
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 1
A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.
Time frame: Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative
Population: Per Protocol Population, with available data at the visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 1 | Week 1 postoperative: Within ± 0.5 D of Target | 31.1 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 1 | Week 1 postoperative: Within ± 1.0 D of Target | 57.8 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 1 | Month 1 postoperative: Within ± 0.5 D of Target | 23.4 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 1 | Month 1 postoperative: Within ± 1.0 D of Target | 48.9 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 1 | Month 3 postoperative: Within ± 0.5 D of Target | 19.1 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 1 | Month 3 postoperative: Within ± 1.0 D of Target | 44.7 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 1 | Month 6 postoperative: Within ± 0.5 D of Target | 14.9 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 1 | Month 6 postoperative: Within ± 1.0 D of Target | 44.7 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 1 | Month 12 postoperative: Within ± 0.5 D of Target | 20.9 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 1 | Month 12 postoperative: Within ± 1.0 D of Target | 37.2 percentage of eyes |
Primary
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2
A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Week 1 postoperative, Month 1 postoperative, and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.
Time frame: Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange
Population: Per Protocol Population, with available data at the visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2 | Week 1 postoperative: Within ± 0.5 D of Target | 35.9 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2 | Week 1 postoperative: Within ± 1.0 D of Target | 79.7 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2 | Month 1 postoperative: Within ± 0.5 D of Target | 29.2 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2 | Month 1 postoperative: Within ± 1.0 D of Target | 70.8 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2 | Month 3 postoperative: Within ± 0.5 D of Target | 20.0 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2 | Month 3 postoperative: Within ± 1.0 D of Target | 58.5 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2 | Week 1 post-exchange: Within ± 0.5 D of Target | 76.9 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2 | Week 1 post-exchange: Within ± 1.0 D of Target | 98.5 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2 | Month 1 post-exchange: Within ± 0.5 D of Target | 82.8 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2 | Month 1 post-exchange: Within ± 1.0 D of Target | 100.0 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2 | Month 3 post-exchange: Within ± 0.5 D of Target | 81.0 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2 | Month 3 post-exchange: Within ± 1.0 D of Target | 98.4 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2 | Month 6 post-exchange: Within ± 0.5 D of Target | 84.1 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2 | Month 6 post-exchange: Within ± 1.0 D of Target | 100.0 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2 | Month 12 post-exchange: Within ± 0.5 D of Target | 77.4 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2 | Month 12 post-exchange: Within ± 1.0 D of Target | 95.2 percentage of eyes |
Primary
Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Fellow Eye
A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). This analysis was prespecified for the fellow eye. No formal statistical hypothesis testing was planned.
Time frame: Month 1 postoperative, Month 3 postoperative, Month 12 postoperative
Population: Per Protocol Population, with available data at the visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Fellow Eye | Month 1 postoperative: Within ± 0.5 D of Target | 78.5 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Fellow Eye | Month 1 postoperative: Within ± 1.0 D of Target | 98.1 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Fellow Eye | Month 3 postoperative: Within ± 0.5 D of Target | 81.1 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Fellow Eye | Month 3 postoperative: Within ± 1.0 D of Target | 99.1 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Fellow Eye | Month 12 postoperative: Within ± 0.5 D of Target | 72.2 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Fellow Eye | Month 12 postoperative: Within ± 1.0 D of Target | 97.2 percentage of eyes |
Primary
Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2
VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye, Cohort 2 only. No formal statistical hypothesis testing was planned.
Time frame: Day 1 post-optic exchange, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange
Population: Per Protocol Population, with available data at the visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All HMIOL Cohort | Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2 | 20/40 Snellen or Better | 87.7 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2 | 20/25 Snellen or Better | 67.7 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2 | 20/20 Snellen or Better | 41.5 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2 | Worse than 20/40 Snellen | 12.3 percentage of eyes |
| All HMIOL Cohort | Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2 | 20/32 Snellen or Better | 80.0 percentage of eyes |
| Cohort 2 Week 1 Post-optic Exchange | Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2 | 20/25 Snellen or Better | 69.2 percentage of eyes |
| Cohort 2 Week 1 Post-optic Exchange | Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2 | 20/40 Snellen or Better | 93.8 percentage of eyes |
| Cohort 2 Week 1 Post-optic Exchange | Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2 | 20/20 Snellen or Better | 47.7 percentage of eyes |
| Cohort 2 Week 1 Post-optic Exchange | Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2 | Worse than 20/40 Snellen | 6.2 percentage of eyes |
| Cohort 2 Week 1 Post-optic Exchange | Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2 | 20/32 Snellen or Better | 87.7 percentage of eyes |
| Cohort 2 Month 1 Post-optic Exchange | Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2 | 20/25 Snellen or Better | 70.3 percentage of eyes |
| Cohort 2 Month 1 Post-optic Exchange | Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2 | 20/40 Snellen or Better | 96.9 percentage of eyes |
| Cohort 2 Month 1 Post-optic Exchange | Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2 | Worse than 20/40 Snellen | 3.1 percentage of eyes |
| Cohort 2 Month 1 Post-optic Exchange | Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2 | 20/32 Snellen or Better | 92.2 percentage of eyes |
| Cohort 2 Month 1 Post-optic Exchange | Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2 | 20/20 Snellen or Better | 53.1 percentage of eyes |
| Cohort 2 Month 3 Post-optic Exchange | Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2 | 20/32 Snellen or Better | 93.7 percentage of eyes |
| Cohort 2 Month 3 Post-optic Exchange | Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2 | 20/20 Snellen or Better | 49.2 percentage of eyes |
| Cohort 2 Month 3 Post-optic Exchange | Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2 | 20/25 Snellen or Better | 81.0 percentage of eyes |
| Cohort 2 Month 3 Post-optic Exchange | Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2 | 20/40 Snellen or Better | 96.8 percentage of eyes |
| Cohort 2 Month 3 Post-optic Exchange | Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2 | Worse than 20/40 Snellen | 3.2 percentage of eyes |
| Cohort 2 Month 6 Post-optic Exchange | Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2 | 20/40 Snellen or Better | 98.4 percentage of eyes |
| Cohort 2 Month 6 Post-optic Exchange | Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2 | 20/20 Snellen or Better | 55.6 percentage of eyes |
| Cohort 2 Month 6 Post-optic Exchange | Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2 | Worse than 20/40 Snellen | 1.6 percentage of eyes |
| Cohort 2 Month 6 Post-optic Exchange | Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2 | 20/25 Snellen or Better | 79.4 percentage of eyes |
| Cohort 2 Month 6 Post-optic Exchange | Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2 | 20/32 Snellen or Better | 93.7 percentage of eyes |
| Cohort 2 Month 12 Post-optic Exchange | Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2 | 20/20 Snellen or Better | 50.0 percentage of eyes |
| Cohort 2 Month 12 Post-optic Exchange | Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2 | 20/40 Snellen or Better | 95.2 percentage of eyes |
| Cohort 2 Month 12 Post-optic Exchange | Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2 | 20/25 Snellen or Better | 74.2 percentage of eyes |
| Cohort 2 Month 12 Post-optic Exchange | Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2 | Worse than 20/40 Snellen | 4.8 percentage of eyes |
| Cohort 2 Month 12 Post-optic Exchange | Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2 | 20/32 Snellen or Better | 83.9 percentage of eyes |