Aphakia, Cataract
Conditions
Keywords
intraocular lens, IOL, intraoperative exchange
Brief summary
The purpose of this study was to evaluate visual and refractive outcomes with the use of the HARMONI™ Modular Intraocular Lens (HMIOL) System implantation, assembly, and optic exchange in subjects undergoing cataract surgery.
Detailed description
All subjects were implanted with the HARMONI™ Modular Intraocular Lens (HMIOL) System in the right eye, left eye, or both eyes based on the best interest of the subject and the clinical judgment the Investigator (Day 0, primary implantation) (Cohort 1). At Month 1 post primary implantation, subjects were given the option to undergo an optic exchange procedure. Subjects who underwent the optic exchange (Cohort 2) (Day 0, optic exchange) were followed for an additional month. Subjects who did not undergo an optic exchange were exited from the study, except at 1 site, which followed subjects up to Month 12. Alcon Research, LLC, acquired ClarVista Medical in 2017. This study was designed and conducted by ClarVista Medical, Inc. 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.
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
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Able to understand and sign an approved Informed Consent Form (ICF); * Willing and able to return for scheduled treatment and follow-up examinations; * Planned removal of cataracts (cortical, nuclear, subcapsular, or a combination) by manual phacoemulsification cataract extraction; Key
Exclusion criteria
* Any ocular conditions which could affect the stability of the IOL in either eye; * Traumatic or congenital cataract; * Pregnancy or planned pregnancy during the study period; * Medications that may confound the outcome or increase risk to the subject; * Any clinical finding or intraocular complication during primary cataract surgery or Implantation of the lens system likely to increase complications or risk to the subject; * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | Day 1 post primary implantation, Week 1 post primary implantation, Month 1 post primary implantation, Month 3 post primary implantation, Month 6 post primary implantation, Month 12 post primary implantation | Visual acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant 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. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned. |
| Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | Day 0 pre optic exchange, Day 1 post optic exchange, Week 1 post optic exchange, Month 1 post optic exchange | Visual acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant 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. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned. The optic exchange occurred 1 month following primary implantation with HMIOL. |
| Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | Baseline (Day -90 to Day 0 preoperative), Week 1 post primary implantation, Month 1 post primary implantation, Month 3 post primary implantation, Month 6 post primary implantation, Month 12 post primary implantation | Visual acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with subject manifest refraction in place. 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. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned. |
| Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | Baseline (Day 0 pre optic exchange), Week 1 post optic exchange, Month 1 post optic exchange | Visual acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with subject manifest refraction in place. 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. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned. |
| Mean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 1 | Baseline (Day -90 to Day 0 preoperative), Week 1 post primary implantation, Month 1 post primary implantation, Month 3 post primary implantation, Month 6 post primary implantation, Month 12 post primary implantation | A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The subject was manually refracted to his/her best correction. The manifest refraction spherical equivalent (MRSE) was measured in diopters (D) and calculated as follows: sphere + 1/2 cylinder. A less negative value indicates a more accurate IOL power calculation. No formal statistical hypothesis testing was planned. |
| Mean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 2 | Baseline (Day 0 pre optic exchange), Week 1 post optic exchange, Month 1 post optic exchange | A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The subject was manually refracted to his/her best correction. The manifest refraction spherical equivalent (MRSE) was measured in diopters (D) and calculated as follows: sphere + 1/2 cylinder. A less negative value indicates a more accurate IOL power calculation. No formal statistical hypothesis testing was planned. |
| Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Base Implantation? - All HMIOL Cohort | Day 0 primary implantation | The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned. |
| Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly? - All HMIOL Cohort | Day 0 primary implantation | The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned. |
| Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly (Exchange)? - Cohort 2 | Day 0 post-exchange | The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned. |
| Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Disassembly? - Cohort 2 | Day 0 post-exchange | The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned. |
| Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Explantation? - Cohort 2 | Day 0 post-exchange | The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned. |
| Number of Secondary Surgical Interventions (SSI) (Other Than Optic Exchange) | Cohort 1: Up to one month post primary implantation, with one site followed up to 12 months. Cohort 2: Up to one month post exchange, for a total of up to 2 months. | A secondary surgical intervention (SSI) was defined as a surgical procedure that occurred after primary implantation and was conducted for the purpose of resolving residual refractive error (RRE) and optimizing visual outcomes, as determined by the investigator. No formal statistical hypothesis testing was planned. |
| Number of Device Deficiencies | Cohort 1: Up to one month post primary implantation, with one site followed up to 12 months. Cohort 2: Up to one month post exchange, for a total of up to 2 months. | A device deficiency was defined as a failure of the device to meet its performance specifications or expectations, or otherwise not perform as intended. This could include either a malfunction or damage to the device or any part thereof, regardless of the source of malfunction or damage, including user error, and regardless of the presence of injury (or lack thereof) to subject, user, or bystander. No formal statistical hypothesis testing was planned. |
Participant flow
Recruitment details
A total of 5 Investigators participated in the study; 3 in the Philippines, 1 in Mexico, and 1 in Panama.
Pre-assignment details
Of the 150 subjects enrolled, 72 were exited from the study prior to attempted implantation with the HARMONI™ Modular Intraocular Lens (HMIOL) System. This reporting group includes all subjects / eyes with attempted implantation.
Participants by arm
| Arm | Count |
|---|---|
| All HMIOL Cohort All subjects with attempted implantation of the HARMONI™ Modular Intraocular Lens (HMIOL) System in the right eye, left eye, or both eyes | 78 |
| Total | 78 |
Baseline characteristics
| Characteristic | All HMIOL Cohort |
|---|---|
| Age, Continuous | 68.4 years STANDARD_DEVIATION 8.98 |
| Race/Ethnicity, Customized Asian | 50 Participants |
| Race/Ethnicity, Customized Black | 0 Participants |
| Race/Ethnicity, Customized Caucasian | 0 Participants |
| Race/Ethnicity, Customized Other | 28 Participants |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 78 | 0 / 100 |
| other Total, other adverse events | 0 / 78 | 12 / 100 |
| serious Total, serious adverse events | 0 / 78 | 0 / 100 |
Outcome results
Primary
Mean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 1
A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The subject was manually refracted to his/her best correction. The manifest refraction spherical equivalent (MRSE) was measured in diopters (D) and calculated as follows: sphere + 1/2 cylinder. A less negative value indicates a more accurate IOL power calculation. No formal statistical hypothesis testing was planned.
Time frame: Baseline (Day -90 to Day 0 preoperative), Week 1 post primary implantation, Month 1 post primary implantation, Month 3 post primary implantation, Month 6 post primary implantation, Month 12 post primary implantation
Population: Per Protocol: All subjects/eyes with successful implantation of HMIOL with no major protocol deviations and available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 - Day 1 Post Primary Implantation | Mean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 1 | -0.53 diopter | Standard Deviation 2.7 |
| Cohort 1 - Week 1 Post Primary Implantation | Mean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 1 | -0.28 diopter | Standard Deviation 0.62 |
| Cohort 1 - Month 1 Post Primary Implantation | Mean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 1 | -0.29 diopter | Standard Deviation 0.63 |
| Cohort 1 - Month 3 Post Primary Implantation | Mean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 1 | -0.58 diopter | Standard Deviation 0.57 |
| Cohort 1 - Month 6 Post Primary Implantation | Mean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 1 | -0.49 diopter | Standard Deviation 0.61 |
| Cohort 1 - Month 12 Post Primary Implantation | Mean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 1 | -0.40 diopter | Standard Deviation 0.69 |
Primary
Mean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 2
A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The subject was manually refracted to his/her best correction. The manifest refraction spherical equivalent (MRSE) was measured in diopters (D) and calculated as follows: sphere + 1/2 cylinder. A less negative value indicates a more accurate IOL power calculation. No formal statistical hypothesis testing was planned.
Time frame: Baseline (Day 0 pre optic exchange), Week 1 post optic exchange, Month 1 post optic exchange
Population: Per Protocol: All subjects/eyes with successful implantation of HMIOL with no major protocol deviations and available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 - Day 1 Post Primary Implantation | Mean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 2 | -1.54 diopter | Standard Deviation 0.56 |
| Cohort 1 - Week 1 Post Primary Implantation | Mean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 2 | -0.25 diopter | Standard Deviation 0.25 |
| Cohort 1 - Month 1 Post Primary Implantation | Mean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 2 | -0.17 diopter | Standard Deviation 0.29 |
Primary
Number of Device Deficiencies
A device deficiency was defined as a failure of the device to meet its performance specifications or expectations, or otherwise not perform as intended. This could include either a malfunction or damage to the device or any part thereof, regardless of the source of malfunction or damage, including user error, and regardless of the presence of injury (or lack thereof) to subject, user, or bystander. No formal statistical hypothesis testing was planned.
Time frame: Cohort 1: Up to one month post primary implantation, with one site followed up to 12 months. Cohort 2: Up to one month post exchange, for a total of up to 2 months.
Population: Safety Population: All eyes with attempted HMIOL implantation (successful or aborted after contact with the eye) and available data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 - Day 1 Post Primary Implantation | Number of Device Deficiencies | 4 device deficiencies |
Primary
Number of Secondary Surgical Interventions (SSI) (Other Than Optic Exchange)
A secondary surgical intervention (SSI) was defined as a surgical procedure that occurred after primary implantation and was conducted for the purpose of resolving residual refractive error (RRE) and optimizing visual outcomes, as determined by the investigator. No formal statistical hypothesis testing was planned.
Time frame: Cohort 1: Up to one month post primary implantation, with one site followed up to 12 months. Cohort 2: Up to one month post exchange, for a total of up to 2 months.
Population: Safety Population: All eyes with attempted HMIOL implantation (successful or aborted after contact with the eye) and available data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 - Day 1 Post Primary Implantation | Number of Secondary Surgical Interventions (SSI) (Other Than Optic Exchange) | 4 SSI |
Primary
Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Disassembly? - Cohort 2
The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.
Time frame: Day 0 post-exchange
Population: Safety Population: All eyes with attempted HMIOL implantation (successful or aborted after contact with the eye) and available data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 - Day 1 Post Primary Implantation | Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Disassembly? - Cohort 2 | Very easy | 1 surgeon response |
| Cohort 1 - Day 1 Post Primary Implantation | Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Disassembly? - Cohort 2 | Easy | 3 surgeon response |
Primary
Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Explantation? - Cohort 2
The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.
Time frame: Day 0 post-exchange
Population: Safety Population: All eyes with attempted HMIOL implantation (successful or aborted after contact with the eye) and available data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 - Day 1 Post Primary Implantation | Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Explantation? - Cohort 2 | Very easy | 1 surgeon response |
| Cohort 1 - Day 1 Post Primary Implantation | Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Explantation? - Cohort 2 | Easy | 1 surgeon response |
| Cohort 1 - Day 1 Post Primary Implantation | Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Explantation? - Cohort 2 | Neutral | 2 surgeon response |
Primary
Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly (Exchange)? - Cohort 2
The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.
Time frame: Day 0 post-exchange
Population: Safety Population: All eyes with attempted HMIOL implantation (successful or aborted after contact with the eye) and available data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 - Day 1 Post Primary Implantation | Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly (Exchange)? - Cohort 2 | Very easy | 1 surgeon response |
| Cohort 1 - Day 1 Post Primary Implantation | Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly (Exchange)? - Cohort 2 | Easy | 1 surgeon response |
| Cohort 1 - Day 1 Post Primary Implantation | Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly (Exchange)? - Cohort 2 | Neutral | 2 surgeon response |
Primary
Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Base Implantation? - All HMIOL Cohort
The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.
Time frame: Day 0 primary implantation
Population: Safety Population: All eyes with attempted HMIOL implantation (successful or aborted after contact with the eye) and available data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 - Day 1 Post Primary Implantation | Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Base Implantation? - All HMIOL Cohort | Easier than a traditional single piece IOL | 35 surgeon response |
| Cohort 1 - Day 1 Post Primary Implantation | Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Base Implantation? - All HMIOL Cohort | The same as a traditional single piece IOL | 11 surgeon response |
| Cohort 1 - Day 1 Post Primary Implantation | Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Base Implantation? - All HMIOL Cohort | Slightly more difficult than a trd'l single pc IOL | 34 surgeon response |
| Cohort 1 - Day 1 Post Primary Implantation | Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Base Implantation? - All HMIOL Cohort | Slightly easier than a traditional single piece IO | 16 surgeon response |
| Cohort 1 - Day 1 Post Primary Implantation | Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Base Implantation? - All HMIOL Cohort | More difficult than a traditional single piece IOL | 2 surgeon response |
Primary
Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly? - All HMIOL Cohort
The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.
Time frame: Day 0 primary implantation
Population: Safety Population: All eyes with attempted HMIOL implantation (successful or aborted after contact with the eye) and available data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 - Day 1 Post Primary Implantation | Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly? - All HMIOL Cohort | Very easy | 31 surgeon response |
| Cohort 1 - Day 1 Post Primary Implantation | Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly? - All HMIOL Cohort | Easy | 23 surgeon response |
| Cohort 1 - Day 1 Post Primary Implantation | Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly? - All HMIOL Cohort | Neutral | 35 surgeon response |
| Cohort 1 - Day 1 Post Primary Implantation | Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly? - All HMIOL Cohort | Difficult | 8 surgeon response |
| Cohort 1 - Day 1 Post Primary Implantation | Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly? - All HMIOL Cohort | Very difficult | 1 surgeon response |
Primary
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1
Visual acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with subject manifest refraction in place. 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. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned.
Time frame: Baseline (Day -90 to Day 0 preoperative), Week 1 post primary implantation, Month 1 post primary implantation, Month 3 post primary implantation, Month 6 post primary implantation, Month 12 post primary implantation
Population: Per Protocol: All subjects/eyes with successful implantation of HMIOL with no major protocol deviations and available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 - Day 1 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/40 Snellen or Better | 58.7 percentage of eyes |
| Cohort 1 - Day 1 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/32 Snellen or Better | 44.6 percentage of eyes |
| Cohort 1 - Day 1 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/20 Snellen or Better | 13.0 percentage of eyes |
| Cohort 1 - Day 1 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | Worse than 20/40 Snellen | 41.3 percentage of eyes |
| Cohort 1 - Day 1 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/25 Snellen or Better | 23.9 percentage of eyes |
| Cohort 1 - Week 1 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/25 Snellen or Better | 83.5 percentage of eyes |
| Cohort 1 - Week 1 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/32 Snellen or Better | 94.8 percentage of eyes |
| Cohort 1 - Week 1 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/40 Snellen or Better | 96.9 percentage of eyes |
| Cohort 1 - Week 1 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/20 Snellen or Better | 76.3 percentage of eyes |
| Cohort 1 - Week 1 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | Worse than 20/40 Snellen | 3.1 percentage of eyes |
| Cohort 1 - Month 1 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/40 Snellen or Better | 99.0 percentage of eyes |
| Cohort 1 - Month 1 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/20 Snellen or Better | 72.2 percentage of eyes |
| Cohort 1 - Month 1 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/25 Snellen or Better | 92.8 percentage of eyes |
| Cohort 1 - Month 1 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/32 Snellen or Better | 96.9 percentage of eyes |
| Cohort 1 - Month 1 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | Worse than 20/40 Snellen | 1.0 percentage of eyes |
| Cohort 1 - Month 3 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/20 Snellen or Better | 83.3 percentage of eyes |
| Cohort 1 - Month 3 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/40 Snellen or Better | 100.0 percentage of eyes |
| Cohort 1 - Month 3 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/32 Snellen or Better | 100.0 percentage of eyes |
| Cohort 1 - Month 3 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | Worse than 20/40 Snellen | 0.0 percentage of eyes |
| Cohort 1 - Month 3 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/25 Snellen or Better | 100.0 percentage of eyes |
| Cohort 1 - Month 6 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/25 Snellen or Better | 100.0 percentage of eyes |
| Cohort 1 - Month 6 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/32 Snellen or Better | 100.0 percentage of eyes |
| Cohort 1 - Month 6 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/40 Snellen or Better | 100.0 percentage of eyes |
| Cohort 1 - Month 6 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/20 Snellen or Better | 91.7 percentage of eyes |
| Cohort 1 - Month 6 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | Worse than 20/40 Snellen | 0.0 percentage of eyes |
| Cohort 1 - Month 12 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/20 Snellen or Better | 58.3 percentage of eyes |
| Cohort 1 - Month 12 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | Worse than 20/40 Snellen | 0.0 percentage of eyes |
| Cohort 1 - Month 12 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/32 Snellen or Better | 100.0 percentage of eyes |
| Cohort 1 - Month 12 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/40 Snellen or Better | 100.0 percentage of eyes |
| Cohort 1 - Month 12 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 | 20/25 Snellen or Better | 91.7 percentage of eyes |
Primary
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2
Visual acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with subject manifest refraction in place. 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. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned.
Time frame: Baseline (Day 0 pre optic exchange), Week 1 post optic exchange, Month 1 post optic exchange
Population: Per Protocol: All subjects/eyes with successful implantation of HMIOL with no major protocol deviations and available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 - Day 1 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | 20/40 Snellen or Better | 100.0 percentage of eyes |
| Cohort 1 - Day 1 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | 20/32 Snellen or Better | 100.0 percentage of eyes |
| Cohort 1 - Day 1 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | Worse than 20/40 Snellen | 0.0 percentage of eyes |
| Cohort 1 - Day 1 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | 20/25 Snellen or Better | 66.7 percentage of eyes |
| Cohort 1 - Day 1 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | 20/20 Snellen or Better | 33.3 percentage of eyes |
| Cohort 1 - Week 1 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | 20/20 Snellen or Better | 100.0 percentage of eyes |
| Cohort 1 - Week 1 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | 20/25 Snellen or Better | 100.0 percentage of eyes |
| Cohort 1 - Week 1 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | 20/32 Snellen or Better | 100.0 percentage of eyes |
| Cohort 1 - Week 1 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | 20/40 Snellen or Better | 100.0 percentage of eyes |
| Cohort 1 - Week 1 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | Worse than 20/40 Snellen | 0.0 percentage of eyes |
| Cohort 1 - Month 1 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | Worse than 20/40 Snellen | 0.0 percentage of eyes |
| Cohort 1 - Month 1 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | 20/40 Snellen or Better | 100.0 percentage of eyes |
| Cohort 1 - Month 1 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | 20/20 Snellen or Better | 66.7 percentage of eyes |
| Cohort 1 - Month 1 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | 20/32 Snellen or Better | 100.0 percentage of eyes |
| Cohort 1 - Month 1 Post Primary Implantation | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 | 20/25 Snellen or Better | 100.0 percentage of eyes |
Primary
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1
Visual acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant 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. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned.
Time frame: Day 1 post primary implantation, Week 1 post primary implantation, Month 1 post primary implantation, Month 3 post primary implantation, Month 6 post primary implantation, Month 12 post primary implantation
Population: Per Protocol: All subjects/eyes with successful implantation of HMIOL with no major protocol deviations and available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 - Day 1 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/40 Snellen or Better | 85.4 percentage of eyes |
| Cohort 1 - Day 1 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/25 Snellen or Better | 53.1 percentage of eyes |
| Cohort 1 - Day 1 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/20 Snellen or Better | 30.2 percentage of eyes |
| Cohort 1 - Day 1 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | Worse than 20/40 Snellen | 14.6 percentage of eyes |
| Cohort 1 - Day 1 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/32 Snellen or Better | 74.0 percentage of eyes |
| Cohort 1 - Week 1 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/25 Snellen or Better | 61.9 percentage of eyes |
| Cohort 1 - Week 1 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/40 Snellen or Better | 89.7 percentage of eyes |
| Cohort 1 - Week 1 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/20 Snellen or Better | 32.0 percentage of eyes |
| Cohort 1 - Week 1 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | Worse than 20/40 Snellen | 10.3 percentage of eyes |
| Cohort 1 - Week 1 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/32 Snellen or Better | 84.5 percentage of eyes |
| Cohort 1 - Month 1 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/25 Snellen or Better | 60.8 percentage of eyes |
| Cohort 1 - Month 1 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/40 Snellen or Better | 93.8 percentage of eyes |
| Cohort 1 - Month 1 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | Worse than 20/40 Snellen | 6.2 percentage of eyes |
| Cohort 1 - Month 1 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/32 Snellen or Better | 78.4 percentage of eyes |
| Cohort 1 - Month 1 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/20 Snellen or Better | 32.0 percentage of eyes |
| Cohort 1 - Month 3 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/32 Snellen or Better | 91.7 percentage of eyes |
| Cohort 1 - Month 3 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/20 Snellen or Better | 16.7 percentage of eyes |
| Cohort 1 - Month 3 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/25 Snellen or Better | 58.3 percentage of eyes |
| Cohort 1 - Month 3 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/40 Snellen or Better | 91.7 percentage of eyes |
| Cohort 1 - Month 3 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | Worse than 20/40 Snellen | 3.3 percentage of eyes |
| Cohort 1 - Month 6 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/40 Snellen or Better | 100.0 percentage of eyes |
| Cohort 1 - Month 6 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/20 Snellen or Better | 58.3 percentage of eyes |
| Cohort 1 - Month 6 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | Worse than 20/40 Snellen | 0.0 percentage of eyes |
| Cohort 1 - Month 6 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/25 Snellen or Better | 83.3 percentage of eyes |
| Cohort 1 - Month 6 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/32 Snellen or Better | 91.7 percentage of eyes |
| Cohort 1 - Month 12 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/20 Snellen or Better | 25.0 percentage of eyes |
| Cohort 1 - Month 12 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/40 Snellen or Better | 100.0 percentage of eyes |
| Cohort 1 - Month 12 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/25 Snellen or Better | 50.0 percentage of eyes |
| Cohort 1 - Month 12 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | Worse than 20/40 Snellen | 0.0 percentage of eyes |
| Cohort 1 - Month 12 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 | 20/32 Snellen or Better | 66.7 percentage of eyes |
Primary
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2
Visual acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant 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. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned. The optic exchange occurred 1 month following primary implantation with HMIOL.
Time frame: Day 0 pre optic exchange, Day 1 post optic exchange, Week 1 post optic exchange, Month 1 post optic exchange
Population: Per Protocol: All subjects/eyes with successful implantation of HMIOL with no major protocol deviations and available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 - Day 1 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/40 Snellen or Better | 66.7 percentage of eyes |
| Cohort 1 - Day 1 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/20 Snellen or Better | 0.0 percentage of eyes |
| Cohort 1 - Day 1 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | Worse than 20/40 Snellen | 33.3 percentage of eyes |
| Cohort 1 - Day 1 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/32 Snellen or Better | 0.0 percentage of eyes |
| Cohort 1 - Day 1 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/25 Snellen or Better | 0.0 percentage of eyes |
| Cohort 1 - Week 1 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/32 Snellen or Better | 66.7 percentage of eyes |
| Cohort 1 - Week 1 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/40 Snellen or Better | 100.0 percentage of eyes |
| Cohort 1 - Week 1 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/20 Snellen or Better | 66.7 percentage of eyes |
| Cohort 1 - Week 1 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/25 Snellen or Better | 66.7 percentage of eyes |
| Cohort 1 - Week 1 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | Worse than 20/40 Snellen | 0.0 percentage of eyes |
| Cohort 1 - Month 1 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/32 Snellen or Better | 100.0 percentage of eyes |
| Cohort 1 - Month 1 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/20 Snellen or Better | 66.7 percentage of eyes |
| Cohort 1 - Month 1 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/25 Snellen or Better | 66.7 percentage of eyes |
| Cohort 1 - Month 1 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/40 Snellen or Better | 100.0 percentage of eyes |
| Cohort 1 - Month 1 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | Worse than 20/40 Snellen | 0.0 percentage of eyes |
| Cohort 1 - Month 3 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/40 Snellen or Better | 100.0 percentage of eyes |
| Cohort 1 - Month 3 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/25 Snellen or Better | 66.7 percentage of eyes |
| Cohort 1 - Month 3 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/20 Snellen or Better | 66.7 percentage of eyes |
| Cohort 1 - Month 3 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | 20/32 Snellen or Better | 100.0 percentage of eyes |
| Cohort 1 - Month 3 Post Primary Implantation | Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 | Worse than 20/40 Snellen | 0.0 percentage of eyes |