Cataract
Conditions
Brief summary
The purpose of the study is to demonstrate the safety and performance of ACRYSOF IQ extended depth of focus (EDF) intraocular lens (IOL) at Month 6. Depth of focus (DOF) is the amount of focal plane displacement behind a lens that does not degrade the image quality of a distant object. A larger DOF allows sharp images of closer objects and may provide improved vision at intermediate and near distances.
Detailed description
Both eyes of a subject must require cataract surgery to qualify for enrollment into this study. Subjects participating in the trial will attend a total of 9 scheduled study visits over a 7-8 month period. Of the 9 visits, 1 is preoperative, 2 are operative, and the remaining 6 are postoperative visits. Primary endpoint data will be collected at the Month 6 (Day 120-180) post second eye implantation visit.
Interventions
Implantable IOL intending to extend the depth of focus and provide continuous functional vision from distance to near while maintaining distance vision and a visual disturbance profile comparable to a monofocal IOL.
Monofocal IOL implanted for long-term use over the lifetime of the pseudophakic subject
PROCEDURECataract surgery
IOL bilateral implantation
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Best Corrected Distance Visual Acuity (BCDVA) of 0.3 logarithm of the minimum angle of resolution (logMAR) (20/40 Snellen) or worse either with or without a glare source present (e.g., Brightness Acuity Tester) * Preoperative regular astigmatism of \< 1.0 D in both eyes * Clear intraocular media other than cataract * Diagnosed with cataract in both eyes * Planned cataract removal by routine small incision surgery * Calculated lens power between 18.0 and 25.0 diopter (D) \[when targeted for emmetropia (0.0 D)\] * Willing and able to complete all required postoperative visits * Able to comprehend and sign an ethics committee-approved statement of informed consent * Potential postoperative BCDVA of 0.2 logMAR (20/32 Snellen) or better in each eye based on Investigator's medical opinion.
Exclusion criteria
* History of eye pathology and/or inflammation, as specified in the protocol * Clinically significant/severe ocular surface disease that would affect study measurements based on Investigator expert medical opinion * History of previous intraocular or corneal surgery * Pregnant/lactating or has another condition with associated fluctuation of hormones that could lead to refractive changes * Taking systemic medications that in the Investigator's best medical judgment may confound the outcome or increase the risk to the subject.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mesopic Contrast Sensitivity | Month 6 (120-180 days post second eye implantation) | Contrast sensitivity (i.e., the ability to detect objects by distinguishing them from their background) was assessed monocularly with the subject's best spectacle correction under mesopic (low, but not quite dark) conditions at a distance of 8 (2.45 m) feet from the eye at a spatial frequency of 1.5, 3, 6, and 12 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT with and without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. A higher numeric value represented better contrast sensitivity. This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned. |
| Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) [(Logarithm of the Minimum Angle of Resolution (logMAR)] 66 Centimeters (cm) From Spectacle Plane | Month 6 (120-180 days post second eye implantation) | Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction adjusted for optical infinity, electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 66 cm from the spectacle plane. DCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye. |
| Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) logMAR [(4 Meters (m)] From Spectacle Plane | Month 6 (120-180 days post second eye implantation) | VA was tested monocularly under photopic conditions using the correction obtained from the best correction and no optical infinity adjustment, electronic ETDRS charts at a distance of 4 m from the spectacle plane. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye. |
| Monocular Depth of Focus (Measured in the Negative Direction From 0) at 0.20 logMAR From the Mean Defocus Curve | Month 6 (120-180 days post second eye implantation) | Depth of focus was assessed at 4 meters under photopic (well-lit) conditions using best corrected distance refraction and added defocus. The depth of focus was estimated as the dioptric range between zero defocus and the first point on the negative lens induced mean defocus curve that crosses the 0.2 logMAR using a linear interpolation. A lower numeric value represents better VA. This analysis was pre-specified for the first operative eye. No formal statistical hypothesis testing was planned. |
| Percentage of Eyes Achieving Monocular Photopic DCIVA 0.20 logMAR or Better | Month 6 (120-180 days post second eye implantation) | VA was tested monocularly under photopic conditions using best distance correction adjusted for optical infinity, electronic ETDRS charts at a distance of 66 cm from the eye. DCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned. |
| Percentage of Subjects With Ocular Adverse Events | Day 0 (first operative eye visit), up to Month 6 (120-180 days post second eye implantation) | An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular AEs are events localized to the eye. Cumulative and persistent serious adverse events as defined in ISO 11979-7:2014 were collected. This outcome measure was prespecified for the Model DFT015 first and second eyes. No formal statistical hypothesis testing was planned. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Who Respond Never to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire: Overall, in the Past 7 Days, How Often Did You Need to Wear Eyeglasses to See? | Month 6 (120-180 days post second eye implantation) | The IOLSAT questionnaire assessed the subjective quality of vision with respect to need for spectacles, as well as the subject's expectation and satisfaction with their quality of vision at 6 months. Results are reported consistent with multiple testing strategy. |
| Monocular Photopic Uncorrected Intermediate Visual Acuity (UCIVA) (logMAR) 66 cm From Spectacle Plane | Month 6 (120-180 days post second eye implantation) | VA was tested monocularly under photopic conditions with no refractive correction or adjustment for optical infinity, using electronic ETDRS charts at a distance of 66 cm from the spectacle plane. UCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned. |
| Monocular Photopic Uncorrected Distance Visual Acuity (UCDVA) (logMAR) | Month 6 (120-180 days post second eye implantation) | VA was tested monocularly under photopic conditions without refractive correction but with adjustment for optical infinity, electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. UCDVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA.This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned. |
| Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID) | Month 6 (120-180 days post second eye implantation) | Rates of severe and most bothersome visual disturbances as reported by the subjects on the QUVID questionnaire, a Patient Reported Outcome (PRO) questionnaire. No formal statistical hypothesis testing was planned. |
| Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) (logMAR) 40 cm From Spectacle Plane | Month 6 (120-180 days post second eye implantation) | VA was tested monocularly under photopic conditions using best distance correction adjusted for optical infinity, electronic ETDRS chart set at 40 cm from the spectacle plane. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 11 investigative sites located in the United States.
Pre-assignment details
21 subjects discontinued prior to randomization, and 1 subject discontinued after randomization but prior to attempted implantation. This reporting group includes all subjects with attempted implantation, as treated. Note: 1 subject randomized to DFT015 was implanted with SN60WF. Subject withdrew at the 1 month visit.
Participants by arm
| Arm | Count |
|---|---|
| DFT015 ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation | 107 |
| SN60WF ACRYSOF® IQ Monofocal IOL, bilateral implantation | 113 |
| Total | 220 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | SN60WF | Total | DFT015 |
|---|---|---|---|
| Age, Continuous | 68.8 years STANDARD_DEVIATION 6.63 | 68.8 years STANDARD_DEVIATION 7.22 | 68.8 years STANDARD_DEVIATION 7.82 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 111 Participants | 215 Participants | 104 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 110 Participants | 215 Participants | 105 Participants |
| Sex: Female, Male Female | 64 Participants | 123 Participants | 59 Participants |
| Sex: Female, Male Male | 49 Participants | 97 Participants | 48 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 | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 220 | 0 / 107 | 0 / 106 | 0 / 107 | 0 / 113 | 0 / 113 | 0 / 113 |
| other Total, other adverse events | 0 / 220 | 5 / 107 | 6 / 106 | 0 / 107 | 9 / 113 | 8 / 113 | 0 / 113 |
| serious Total, serious adverse events | 0 / 220 | 3 / 107 | 2 / 106 | 7 / 107 | 3 / 113 | 1 / 113 | 4 / 113 |
Outcome results
Primary
Mesopic Contrast Sensitivity
Contrast sensitivity (i.e., the ability to detect objects by distinguishing them from their background) was assessed monocularly with the subject's best spectacle correction under mesopic (low, but not quite dark) conditions at a distance of 8 (2.45 m) feet from the eye at a spatial frequency of 1.5, 3, 6, and 12 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT with and without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. A higher numeric value represented better contrast sensitivity. This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.
Time frame: Month 6 (120-180 days post second eye implantation)
Population: Safety Analysis Set. Number analyzed is the number of subjects/eyes with data available for analysis at without glare and with glare assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DFT015 | Mesopic Contrast Sensitivity | 1.5 cpd Without Glare | 1.506 log unit | Standard Deviation 0.256 |
| DFT015 | Mesopic Contrast Sensitivity | 3 cpd Without Glare | 1.447 log unit | Standard Deviation 0.3381 |
| DFT015 | Mesopic Contrast Sensitivity | 6 cpd Without Glare | 1.340 log unit | Standard Deviation 0.385 |
| DFT015 | Mesopic Contrast Sensitivity | 12 cpd Without Glare | 0.840 log unit | Standard Deviation 0.3681 |
| DFT015 | Mesopic Contrast Sensitivity | 1.5 cpd With Glare | 1.504 log unit | Standard Deviation 0.2555 |
| DFT015 | Mesopic Contrast Sensitivity | 3 cpd With Glare | 1.458 log unit | Standard Deviation 0.3304 |
| DFT015 | Mesopic Contrast Sensitivity | 6 cpd With Glare | 1.364 log unit | Standard Deviation 0.3856 |
| DFT015 | Mesopic Contrast Sensitivity | 12 cpd With Glare | 0.817 log unit | Standard Deviation 0.3494 |
| SN60WF | Mesopic Contrast Sensitivity | 12 cpd With Glare | 0.999 log unit | Standard Deviation 0.402 |
| SN60WF | Mesopic Contrast Sensitivity | 1.5 cpd Without Glare | 1.498 log unit | Standard Deviation 0.2434 |
| SN60WF | Mesopic Contrast Sensitivity | 1.5 cpd With Glare | 1.475 log unit | Standard Deviation 0.2569 |
| SN60WF | Mesopic Contrast Sensitivity | 3 cpd Without Glare | 1.482 log unit | Standard Deviation 0.2829 |
| SN60WF | Mesopic Contrast Sensitivity | 6 cpd With Glare | 1.529 log unit | Standard Deviation 0.3256 |
| SN60WF | Mesopic Contrast Sensitivity | 6 cpd Without Glare | 1.548 log unit | Standard Deviation 0.3177 |
| SN60WF | Mesopic Contrast Sensitivity | 3 cpd With Glare | 1.499 log unit | Standard Deviation 0.2838 |
| SN60WF | Mesopic Contrast Sensitivity | 12 cpd Without Glare | 1.003 log unit | Standard Deviation 0.3769 |
Primary
Monocular Depth of Focus (Measured in the Negative Direction From 0) at 0.20 logMAR From the Mean Defocus Curve
Depth of focus was assessed at 4 meters under photopic (well-lit) conditions using best corrected distance refraction and added defocus. The depth of focus was estimated as the dioptric range between zero defocus and the first point on the negative lens induced mean defocus curve that crosses the 0.2 logMAR using a linear interpolation. A lower numeric value represents better VA. This analysis was pre-specified for the first operative eye. No formal statistical hypothesis testing was planned.
Time frame: Month 6 (120-180 days post second eye implantation)
Population: All-Implanted Analysis Set, as treated. Number analyzed is the number of subjects/eyes with data available for analysis at specified defocus.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DFT015 | Monocular Depth of Focus (Measured in the Negative Direction From 0) at 0.20 logMAR From the Mean Defocus Curve | 1.53 diopter |
| SN60WF | Monocular Depth of Focus (Measured in the Negative Direction From 0) at 0.20 logMAR From the Mean Defocus Curve | 0.99 diopter |
Primary
Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) logMAR [(4 Meters (m)] From Spectacle Plane
VA was tested monocularly under photopic conditions using the correction obtained from the best correction and no optical infinity adjustment, electronic ETDRS charts at a distance of 4 m from the spectacle plane. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.
Time frame: Month 6 (120-180 days post second eye implantation)
Population: All-Implanted Analysis Set, as treated
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DFT015 | Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) logMAR [(4 Meters (m)] From Spectacle Plane | 0.016 logMAR | Standard Error 0.0091 |
| SN60WF | Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) logMAR [(4 Meters (m)] From Spectacle Plane | -0.036 logMAR | Standard Error 0.0089 |
t-test, 2 sided
Primary
Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) [(Logarithm of the Minimum Angle of Resolution (logMAR)] 66 Centimeters (cm) From Spectacle Plane
Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction adjusted for optical infinity, electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 66 cm from the spectacle plane. DCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.
Time frame: Month 6 (120-180 days post second eye implantation)
Population: All-Implanted Analysis Set, as treated
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DFT015 | Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) [(Logarithm of the Minimum Angle of Resolution (logMAR)] 66 Centimeters (cm) From Spectacle Plane | 0.148 logMAR | Standard Error 0.012 |
| SN60WF | Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) [(Logarithm of the Minimum Angle of Resolution (logMAR)] 66 Centimeters (cm) From Spectacle Plane | 0.312 logMAR | Standard Error 0.0118 |
p-value: <0.00195% CI: [-0.197, -0.131]t-test, 2 sided
Primary
Percentage of Eyes Achieving Monocular Photopic DCIVA 0.20 logMAR or Better
VA was tested monocularly under photopic conditions using best distance correction adjusted for optical infinity, electronic ETDRS charts at a distance of 66 cm from the eye. DCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.
Time frame: Month 6 (120-180 days post second eye implantation)
Population: All-Implanted Analysis Set, as treated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DFT015 | Percentage of Eyes Achieving Monocular Photopic DCIVA 0.20 logMAR or Better | 72.9 percentage of eyes |
| SN60WF | Percentage of Eyes Achieving Monocular Photopic DCIVA 0.20 logMAR or Better | 25.2 percentage of eyes |
Primary
Percentage of Subjects With Ocular Adverse Events
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular AEs are events localized to the eye. Cumulative and persistent serious adverse events as defined in ISO 11979-7:2014 were collected. This outcome measure was prespecified for the Model DFT015 first and second eyes. No formal statistical hypothesis testing was planned.
Time frame: Day 0 (first operative eye visit), up to Month 6 (120-180 days post second eye implantation)
Population: This analysis population included all eyes with attempted IOL implantation (successful or aborted after contact with the eye) (Safety Analysis Set).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DFT015 | Percentage of Subjects With Ocular Adverse Events | Cumulative: Pupillary block | 0.0 percentage of subjects |
| DFT015 | Percentage of Subjects With Ocular Adverse Events | Cumulative: Cystoid macular oedema | 0.9 percentage of subjects |
| DFT015 | Percentage of Subjects With Ocular Adverse Events | Cumulative: Hypopyon | 0.0 percentage of subjects |
| DFT015 | Percentage of Subjects With Ocular Adverse Events | Cumulative: Endophthalmitis | 0.0 percentage of subjects |
| DFT015 | Percentage of Subjects With Ocular Adverse Events | Cumulative: Lens dislocated from posterior chamber | 0.0 percentage of subjects |
| DFT015 | Percentage of Subjects With Ocular Adverse Events | Cumulative: Retinal detachment | 0.0 percentage of subjects |
| DFT015 | Percentage of Subjects With Ocular Adverse Events | Cumulative: Secondary surgical intervention | 0.0 percentage of subjects |
| DFT015 | Percentage of Subjects With Ocular Adverse Events | Cumulative: Cataract operation complication | 0.0 percentage of subjects |
| DFT015 | Percentage of Subjects With Ocular Adverse Events | Cumulative: Hyphaema | 0.9 percentage of subjects |
| DFT015 | Percentage of Subjects With Ocular Adverse Events | Cumulative: Transient ischaemic attack | 0.9 percentage of subjects |
| DFT015 | Percentage of Subjects With Ocular Adverse Events | Persistent: Corneal stroma oedema | 0.0 percentage of subjects |
| DFT015 | Percentage of Subjects With Ocular Adverse Events | Persistent: Cystoid macular oedema | 0.0 percentage of subjects |
| DFT015 | Percentage of Subjects With Ocular Adverse Events | Persistent: Iritis | 0.0 percentage of subjects |
| DFT015 | Percentage of Subjects With Ocular Adverse Events | Persistent: Raised IOP requiring treatment | 0.0 percentage of subjects |
| SN60WF | Percentage of Subjects With Ocular Adverse Events | Persistent: Corneal stroma oedema | 0.0 percentage of subjects |
| SN60WF | Percentage of Subjects With Ocular Adverse Events | Cumulative: Cataract operation complication | 1.9 percentage of subjects |
| SN60WF | Percentage of Subjects With Ocular Adverse Events | Cumulative: Cystoid macular oedema | 0.0 percentage of subjects |
| SN60WF | Percentage of Subjects With Ocular Adverse Events | Persistent: Iritis | 0.0 percentage of subjects |
| SN60WF | Percentage of Subjects With Ocular Adverse Events | Cumulative: Hypopyon | 0.0 percentage of subjects |
| SN60WF | Percentage of Subjects With Ocular Adverse Events | Cumulative: Hyphaema | 0.0 percentage of subjects |
| SN60WF | Percentage of Subjects With Ocular Adverse Events | Cumulative: Endophthalmitis | 0.0 percentage of subjects |
| SN60WF | Percentage of Subjects With Ocular Adverse Events | Persistent: Cystoid macular oedema | 0.0 percentage of subjects |
| SN60WF | Percentage of Subjects With Ocular Adverse Events | Cumulative: Lens dislocated from posterior chamber | 0.0 percentage of subjects |
| SN60WF | Percentage of Subjects With Ocular Adverse Events | Cumulative: Pupillary block | 0.0 percentage of subjects |
| SN60WF | Percentage of Subjects With Ocular Adverse Events | Cumulative: Transient ischaemic attack | 0.0 percentage of subjects |
| SN60WF | Percentage of Subjects With Ocular Adverse Events | Cumulative: Retinal detachment | 0.0 percentage of subjects |
| SN60WF | Percentage of Subjects With Ocular Adverse Events | Persistent: Raised IOP requiring treatment | 0.0 percentage of subjects |
| SN60WF | Percentage of Subjects With Ocular Adverse Events | Cumulative: Secondary surgical intervention | 1.9 percentage of subjects |
Secondary
Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) (logMAR) 40 cm From Spectacle Plane
VA was tested monocularly under photopic conditions using best distance correction adjusted for optical infinity, electronic ETDRS chart set at 40 cm from the spectacle plane. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.
Time frame: Month 6 (120-180 days post second eye implantation)
Population: All-Implanted Analysis Set, as treated.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DFT015 | Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) (logMAR) 40 cm From Spectacle Plane | 0.359 logMAR | Standard Error 0.0147 |
| SN60WF | Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) (logMAR) 40 cm From Spectacle Plane | 0.515 logMAR | Standard Error 0.0144 |
p-value: <0.00195% CI: [-0.197, -0.115]t-test, 2 sided
Secondary
Monocular Photopic Uncorrected Distance Visual Acuity (UCDVA) (logMAR)
VA was tested monocularly under photopic conditions without refractive correction but with adjustment for optical infinity, electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. UCDVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA.This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.
Time frame: Month 6 (120-180 days post second eye implantation)
Population: All-Implanted Analysis Set, as treated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DFT015 | Monocular Photopic Uncorrected Distance Visual Acuity (UCDVA) (logMAR) | 0.117 logMAR | Standard Deviation 0.122 |
| SN60WF | Monocular Photopic Uncorrected Distance Visual Acuity (UCDVA) (logMAR) | 0.056 logMAR | Standard Deviation 0.148 |
Secondary
Monocular Photopic Uncorrected Intermediate Visual Acuity (UCIVA) (logMAR) 66 cm From Spectacle Plane
VA was tested monocularly under photopic conditions with no refractive correction or adjustment for optical infinity, using electronic ETDRS charts at a distance of 66 cm from the spectacle plane. UCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.
Time frame: Month 6 (120-180 days post second eye implantation)
Population: All-Implanted Analysis Set, as treated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DFT015 | Monocular Photopic Uncorrected Intermediate Visual Acuity (UCIVA) (logMAR) 66 cm From Spectacle Plane | 0.136 logMAR | Standard Deviation 0.11 |
| SN60WF | Monocular Photopic Uncorrected Intermediate Visual Acuity (UCIVA) (logMAR) 66 cm From Spectacle Plane | 0.261 logMAR | Standard Deviation 0.147 |
Secondary
Percentage of Subjects Who Respond Never to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire: Overall, in the Past 7 Days, How Often Did You Need to Wear Eyeglasses to See?
The IOLSAT questionnaire assessed the subjective quality of vision with respect to need for spectacles, as well as the subject's expectation and satisfaction with their quality of vision at 6 months. Results are reported consistent with multiple testing strategy.
Time frame: Month 6 (120-180 days post second eye implantation)
Population: All-Implanted Analysis Set, as treated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DFT015 | Percentage of Subjects Who Respond Never to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire: Overall, in the Past 7 Days, How Often Did You Need to Wear Eyeglasses to See? | 21.6 percentage of subjects |
| SN60WF | Percentage of Subjects Who Respond Never to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire: Overall, in the Past 7 Days, How Often Did You Need to Wear Eyeglasses to See? | 3.6 percentage of subjects |
95% CI: [9.65, 27.37]
Secondary
Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID)
Rates of severe and most bothersome visual disturbances as reported by the subjects on the QUVID questionnaire, a Patient Reported Outcome (PRO) questionnaire. No formal statistical hypothesis testing was planned.
Time frame: Month 6 (120-180 days post second eye implantation)
Population: Safety Analysis Set. Number analyzed is the number of subjects/eyes with data available for analysis at specified visual disturbances.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DFT015 | Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID) | Severe: Starbursts | 3.8 percentage of subjects |
| DFT015 | Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID) | Severe: Double vision | 0.0 percentage of subjects |
| DFT015 | Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID) | Most Bothersome: Halos | 0.9 percentage of subjects |
| DFT015 | Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID) | Most Bothersome: Blurred vision | 0.9 percentage of subjects |
| DFT015 | Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID) | Most Bothersome: Double vision | 0.0 percentage of subjects |
| DFT015 | Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID) | Severe: Halos | 0.9 percentage of subjects |
| DFT015 | Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID) | Severe: Glare | 0.0 percentage of subjects |
| DFT015 | Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID) | Severe: Hazy vision | 0.0 percentage of subjects |
| DFT015 | Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID) | Severe: Blurred vision | 0.0 percentage of subjects |
| DFT015 | Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID) | Severe: Dark area | 0.9 percentage of subjects |
| DFT015 | Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID) | Most Bothersome: Starbursts | 1.9 percentage of subjects |
| DFT015 | Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID) | Most Bothersome: Glare | 0.0 percentage of subjects |
| DFT015 | Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID) | Most Bothersome: Hazy vision | 0.0 percentage of subjects |
| DFT015 | Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID) | Most Bothersome: Dark area | 0.9 percentage of subjects |
| SN60WF | Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID) | Most Bothersome: Glare | 0.0 percentage of subjects |
| SN60WF | Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID) | Severe: Blurred vision | 0.0 percentage of subjects |
| SN60WF | Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID) | Most Bothersome: Starbursts | 0.9 percentage of subjects |
| SN60WF | Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID) | Severe: Double vision | 0.0 percentage of subjects |
| SN60WF | Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID) | Most Bothersome: Dark area | 0.9 percentage of subjects |
| SN60WF | Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID) | Most Bothersome: Blurred vision | 1.8 percentage of subjects |
| SN60WF | Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID) | Severe: Dark area | 0.9 percentage of subjects |
| SN60WF | Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID) | Severe: Starbursts | 2.7 percentage of subjects |
| SN60WF | Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID) | Most Bothersome: Hazy vision | 0.0 percentage of subjects |
| SN60WF | Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID) | Severe: Halos | 0.9 percentage of subjects |
| SN60WF | Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID) | Most Bothersome: Halos | 0.0 percentage of subjects |
| SN60WF | Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID) | Severe: Glare | 0.0 percentage of subjects |
| SN60WF | Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID) | Most Bothersome: Double vision | 0.0 percentage of subjects |
| SN60WF | Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID) | Severe: Hazy vision | 0.0 percentage of subjects |