Cataract, Eye Diseases, Lens Opacities, Postcataract Aphakia
Conditions
Keywords
Intraocular Lens, Multifocal, Hydrophobic
Brief summary
This study is a prospective, multicenter, randomized, double masked confirmatory trial comparing an investigational trifocal intraocular lens (IOL) and a commercially available monofocal IOL.
Detailed description
The study will include adult subjects with operable cataracts in both eyes who are eligible for phacoemulsification cataract surgery followed by IOL implantation.
Interventions
DEVICEFINEVISION HP IOL
Cataractous lens will be removed in the study eyes and the FINEVISION HP IOL will be implanted in the capsular bag.
DEVICEAlcon AcrySof SN60AT
Cataractous lens will be removed in the study eyes and the Alcon AcrySof SN60AT IOL will be implanted in the capsular bag.
Sponsors
Beaver-Visitec International, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
In order to minimize bias, site personnel performing postoperative study assessments of visual performance will be masked to subject treatment assignment until after the final database lock (masked assessors).
Intervention model description
Approximately 501 subjects will be screened across up to 24 study sites to complete 300 subjects implanted bilaterally with the FINEVISION HP and 150 subjects implanted bilaterally with the control monofocal Alcon AcrySof SN60AT.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female adults, age 22 years or older at the Preoperative Visit. 2. Visually significant cataracts in both eyes that are eligible for phacoemulsification cataract surgery. 3. Willing to undergo cataract surgery in the second operative eye within 7 - 30 days after surgery in the first eye. 4. Projected Best Corrected Distance Visual Acuity (BCDVA) of 0.2 logMAR (20/32 Snellen) or better in each eye after cataract surgery/IOL implantation, as determined by the medical judgement of the Investigator 5. Eligible for receipt of an IOL power within the range of the investigational IOL (+10.0 D to +30.0 D, in 0.50 D increments) in each eye 6. Contact lens users must be willing to discontinue wear of their lenses in accordance with the following requirements: * Rigid gas permeable lenses for ≥ 7 days prior to the Preoperative Visit * Soft contact lenses for ≥ 3 days prior to the Preoperative Visit Contact lens wearers must demonstrate a stable refraction (within ±0.50 D for both sphere and cylinder) in each eye, as determined by manifest refraction on two consecutive examination dates at least one week apart after discontinuation of contact lens wear. 7. Provide signed written consent prior to participation in any study-related procedures. 8. Ability, comprehension, and willingness to follow study instructions, and likely to complete all study visits. 9. Female subjects must be 1-year postmenopausal, surgically sterilized, or, if of childbearing potential, have a negative urine pregnancy test at the Preoperative Visit. Women of childbearing potential must use an acceptable form of contraception throughout the study. Acceptable methods include at least one of the following: intrauterine (intrauterine device), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence.
Exclusion criteria
1. History or presence of, or predisposition to, degenerative visual disorders (e.g., macular degeneration, retinal detachment, proliferative diabetic retinopathy, or other retinal disorders) predicted to result in BCDVA worse than 0.2 LogMAR (20/32 Snellen) in either eye during the study participation period. 2. Significant anterior segment pathology in either eye that might increase intraoperative risk or compromise IOL stability (e.g., pseudoexfoliation syndrome) 3. Reasonably expected to require secondary ocular surgical intervention or laser treatment other than YAG capsulotomy in either eye during the study participation period. 4. Presence of one or more clinically significant corneal abnormalities in either eye, including corneal dystrophy, irregularity, or edema per the Investigator's medical opinion. 5. Previous intraocular, corneal, or retinal detachment surgery, including corneal transplant, LASIK, astigmatic keratotomy and limbal relaxing incisions in either eye 6. Rubella, congenital, traumatic or complicated cataract in either eye 7. Preoperative keratometric astigmatism \> 1.0 D or irregular corneal astigmatism in either eye (Note: corneal incisions intended to reduce astigmatism are not permitted) 8. Clinically significant ocular inflammation or infection present ≤ 30 days in either eye prior to the Preoperative Visit. 9. Presence or history of one or more severe/serious ocular conditions (e.g., glaucoma, uveitis, ocular infection, severe dry eye) in either eye, or any other unstable medical condition (e.g., uncontrolled diabetes) that in the opinion of the Investigator would put the subject's health at risk, confound the results of the study and/or prevent the subject from completing all study visits. 10. Use of medications known to interfere with visual performance, pupil dilation, or iris structure ≤ 30 days prior to the Preoperative Visit. 11. Participation in any study of an investigational, interventional product within 30 days prior to the Preoperative Visit or at any time during the study period. 12. Pregnant or nursing females.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Monocular Distance Log Contrast Sensitivity Mesopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | Month 12 (Day 360-420), post-first eye implantation | Contrast sensitivity (the ability to detect objects by distinguishing them from their background) was measured monocularly under mesopic (dim-lit) conditions with a glare source in log units using the Clinical Trial Suite (M&S Technologies) for sine-wave gratings 1.5, 3, 6, and12 cycles per degree (CPD) at a test distance of 2.5 meters with best-corrected manifest refraction at 4 meters in place with an adjustment of +0.12 D for the 2.5-meter test distance. A more negative numeric log value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure. |
| Mean Monocular Distance Log Contrast Sensitivity Photopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | Month 12 (Day 360-420), post-first eye implantation | Contrast sensitivity (the ability to detect objects by distinguishing them from their background) was measured monocularly under photopic (well-lit) conditions without glare source in log units using the Clinical Trial Suite (M&S Technologies) for sine-wave gratings 3, 6, 12, and 18 cycles per degree (CPD) at a test distance of 2.5 meters with best-corrected manifest refraction at 4 meters in place with an adjustment of +0.12 D for the 2.5-meter test distance. A more negative numeric log value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure. |
| Mean Monocular Distance Log Contrast Sensitivity Photopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | Month 12 (Day 360-420), post-first eye implantation | Contrast sensitivity (the ability to detect objects by distinguishing them from their background) was measured monocularly under photopic (well-lit) conditions with a glare source in log units using the Clinical Trial Suite (M&S Technologies) for sine-wave gratings 3, 6, 12, and 18 cycles per degree (CPD) at a test distance of 2.5 meters with best-corrected manifest refraction at 4 meters in place with an adjustment of +0.12 D for the 2.5-meter test distance. A more negative numeric log value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure. |
| Mean Monocular Distance Log Contrast Sensitivity Mesopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | Month 12 (Day 360-420), post-first eye implantation | Contrast sensitivity (the ability to detect objects by distinguishing them from their background) was measured monocularly under mesopic (dim-lit) conditions without glare source in log units using the Clinical Trial Suite (M&S Technologies) for sine-wave gratings 1.5, 3, 6, and 12 cycles per degree (CPD) at a test distance of 2.5 meters with best-corrected manifest refraction at 4 meters in place with an adjustment of +0.12 D for the 2.5-meter test distance. A more negative numeric log value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure. |
| Mean Photopic Monocular logMAR Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters in First Operative Eyes | 150-180 days after surgery on the first eyes | Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using the correction obtained from the manifest refraction and electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts on a CTS (Clinical Trial Suite, M&S Technologies) device at a distance of 4 meters (m) from the eye. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower or negative value represents better visual acuity. The mean logMAR values of the two groups were compared to demonstrate non-inferiority of FINEVISION HP trifocal IOL to the control IOL in mean photopic monocular logMAR BCDVA (best corrected distance visual acuity) for the first operative eyes. |
| Mean Photopic Monocular logMAR Distance Corrected Near Visual Acuity (DCNVA) for the First Operative Eyes. | 150-180 days after surgery on the first eyes | VA was tested monocularly under photopic (well-lit) conditions using the manifest refraction adjusted for optical infinity and electronic ETDRS charts at a distance of 40 centimeters (cm) from the eye. Distance corrected visual acuity at near was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower value represents better visual acuity. The mean logMAR values of the two groups were compared to demonstrate superiority of FINEVISION HP trifocal IOL to the control in mean photopic monocular logMAR DCNVA for the first operative eyes. |
| Percentage of 1st Operative Eyes With Secondary Surgical Interventions (SSIs) Related to Optical Properties of IOL for up to Month 12 (Visit 5) | Up to Month 12 (Day 360-420), post first eye implantation | The number of SSI's related to the optical properties of the IOL was calculated from the time of implantation up to Month 12. The percentage of SSIs was calculated as (# of first operative eyes with an SSI related to the optical properties of the IOL) divided by (# of first operative eyes with successful IOL implantation) times 100. The percentages were compared in the two groups to demonstrate noninferiority of FINEVISION HP IOL compared to AcrySof SN60AT IOL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of First Operative Eyes With Cumulative and Persistent Adverse Events at Month 12 (Visit 5) in Comparison to the ISO Safety and Performance Endpoint (SPE) Rates as Described in ISO 11979-7 | Month 12 (Day 360-420), post-first eye implantation | The number and percentage of the first operative eyes with cumulative and persistent adverse events as noted in ISO 11979-7 were calculated for the two IOL groups and compared with the ISO Safety and Performance Endpoint (SPE) rates from ISO 11979-7 Table E.2. A p-value was calculated for each adverse event for each IOL group to determine the statistical significance of the difference in the percentages. |
| Evaluate Visual Disturbances Using the Quality of Vision (QoV) Questionnaire and QoV Supplemental Questions at Month 12 (Visit 5) | Month 12 (Day 360-420), post-first eye implantation | The Quality of Vision (QoV) questionnaire was used to assess subjective visual disturbances reported by subjects receiving IOLs. The QoV asked the subject to rate the frequency, severity, and degree of bothersomeness for 10 items/visual disturbances in their everyday life based on the past week. The rating scales for frequency, severity, and degree of bothersomeness were: * Frequency: 0 (Never), 1 (Occasionally), 2 (Quite Often), 3 (Very Often) * Severity: 0 (Not at all), 1 (Mild), 2 (Moderate), 3 (Severe) * Bothersome: 0 (Not at all), 1 (A little), 2 (Quite), 3 (Very) Scores for each subscale (frequency, severity, degree of bothersomeness) ranging from 0 to 100, with higher scores indicating a higher degree of visual disturbances, were computed using a Rasch scoring algorithm which utilized data from the original validation of the QoV. Hypothesis testing was not planned for this outcome measure. |
| Mean Photopic Monocular logMAR Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm for the First Operative Eyes. | 150-180 days after surgery on the first eye | VA was tested monocularly under photopic(well-lit) conditions using the manifest refraction adjusted for optical infinity and electronic ETDRS charts at a distance of 66 centimeters (cm) from the eye. DCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower value represents better visual acuity. The mean logMAR values of the two groups were compared to demonstrate superiority of FINEVISION HP trifocal IOL to the control in mean photopic monocular logMAR DCIVA for the first operative eyes. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 20 investigative sites located in the United States.
Pre-assignment details
Of the 539 enrolled, 27 exited as screen failures prior to randomization. A total of 512 Participants were randomized in a ratio of 2:1 to receive either the FINEVISION HP Trifocal Intraocular lens (IOL) or the AcrySof SN60AT Monofocal IOL (control) IOL in both eyes. 16 participants discontinued after randomization but before implantation. A total of 496 participants were implanted with either FINEVISION HP Trifocal IOL or the control IOL (3 subjects unilaterally, 493 subjects bilaterally).
Participants by arm
| Arm | Count |
|---|---|
| FINEVISION HP Trifocal IOL (Test Group) FINEVISION HP Trifocal IOL implanted in the capsular bag after removal of cataractous lens by phacoemulsification in both eyes on 2 separate operative visits. | 332 |
| Alcon AcrySof SN60AT Monofocal IOL (Control Group) Alcon AcrySof SN60AT Monofocal IOL implanted in the capsular bag after removal of cataractous lens by phacoemulsification in both eyes on 2 separate operative visits. | 164 |
| Total | 496 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 2 |
| Overall Study | Lost to Follow-up | 10 | 2 |
| Overall Study | Withdrawal by Subject | 6 | 1 |
Baseline characteristics
| Characteristic | FINEVISION HP Trifocal IOL (Test Group) | Alcon AcrySof SN60AT Monofocal IOL (Control Group) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 233 Participants | 126 Participants | 359 Participants |
| Age, Categorical Between 18 and 65 years | 99 Participants | 38 Participants | 137 Participants |
| Age, Continuous | 67.1 years STANDARD_DEVIATION 7.41 | 67.8 years STANDARD_DEVIATION 6.78 | 67.3 years STANDARD_DEVIATION 7.21 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants | 7 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 305 Participants | 157 Participants | 462 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 3 Participants | 16 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 11 Participants | 30 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) White | 294 Participants | 148 Participants | 442 Participants |
| Sex: Female, Male Female | 211 Participants | 102 Participants | 313 Participants |
| Sex: Female, Male Male | 121 Participants | 62 Participants | 183 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 |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 332 | 0 / 329 | 0 / 164 | 0 / 164 | 1 / 332 | 2 / 164 |
| other Total, other adverse events | 17 / 332 | 23 / 329 | 13 / 164 | 12 / 164 | 0 / 332 | 0 / 164 |
| serious Total, serious adverse events | 8 / 332 | 2 / 329 | 2 / 164 | 1 / 164 | 11 / 332 | 9 / 164 |
Outcome results
Primary
Mean Monocular Distance Log Contrast Sensitivity Mesopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
Contrast sensitivity (the ability to detect objects by distinguishing them from their background) was measured monocularly under mesopic (dim-lit) conditions with a glare source in log units using the Clinical Trial Suite (M&S Technologies) for sine-wave gratings 1.5, 3, 6, and12 cycles per degree (CPD) at a test distance of 2.5 meters with best-corrected manifest refraction at 4 meters in place with an adjustment of +0.12 D for the 2.5-meter test distance. A more negative numeric log value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
Time frame: Month 12 (Day 360-420), post-first eye implantation
Population: Best Case Set - First Operative Eyes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FINEVISION HP | Mean Monocular Distance Log Contrast Sensitivity Mesopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | 1.5 cycles per degree (cpd) | -1.355 log units | Standard Deviation 0.3495 |
| FINEVISION HP | Mean Monocular Distance Log Contrast Sensitivity Mesopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | 3 cycles per degree (cpd) | -1.453 log units | Standard Deviation 0.3331 |
| FINEVISION HP | Mean Monocular Distance Log Contrast Sensitivity Mesopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | 6 cycles per degree (cpd) | -1.193 log units | Standard Deviation 0.4006 |
| FINEVISION HP | Mean Monocular Distance Log Contrast Sensitivity Mesopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | 12 cycles per degree (cpd) | -0.598 log units | Standard Deviation 0.4356 |
| Control Product | Mean Monocular Distance Log Contrast Sensitivity Mesopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | 12 cycles per degree (cpd) | -0.822 log units | Standard Deviation 0.3641 |
| Control Product | Mean Monocular Distance Log Contrast Sensitivity Mesopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | 1.5 cycles per degree (cpd) | -1.402 log units | Standard Deviation 0.3706 |
| Control Product | Mean Monocular Distance Log Contrast Sensitivity Mesopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | 6 cycles per degree (cpd) | -1.407 log units | Standard Deviation 0.3851 |
| Control Product | Mean Monocular Distance Log Contrast Sensitivity Mesopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | 3 cycles per degree (cpd) | -1.605 log units | Standard Deviation 0.3278 |
Primary
Mean Monocular Distance Log Contrast Sensitivity Mesopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
Contrast sensitivity (the ability to detect objects by distinguishing them from their background) was measured monocularly under mesopic (dim-lit) conditions without glare source in log units using the Clinical Trial Suite (M&S Technologies) for sine-wave gratings 1.5, 3, 6, and 12 cycles per degree (CPD) at a test distance of 2.5 meters with best-corrected manifest refraction at 4 meters in place with an adjustment of +0.12 D for the 2.5-meter test distance. A more negative numeric log value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
Time frame: Month 12 (Day 360-420), post-first eye implantation
Population: Best Case Set - First Operative Eyes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FINEVISION HP | Mean Monocular Distance Log Contrast Sensitivity Mesopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | 1.5 cycles per degree (cpd) | -1.709 log units | Standard Deviation 0.2872 |
| FINEVISION HP | Mean Monocular Distance Log Contrast Sensitivity Mesopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | 3 cycles per degree (cpd) | -1.735 log units | Standard Deviation 0.2966 |
| FINEVISION HP | Mean Monocular Distance Log Contrast Sensitivity Mesopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | 6 cycles per degree (cpd) | -1.418 log units | Standard Deviation 0.3054 |
| FINEVISION HP | Mean Monocular Distance Log Contrast Sensitivity Mesopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | 12 cycles per degree (cpd) | -0.778 log units | Standard Deviation 0.3572 |
| Control Product | Mean Monocular Distance Log Contrast Sensitivity Mesopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | 12 cycles per degree (cpd) | -0.945 log units | Standard Deviation 0.3419 |
| Control Product | Mean Monocular Distance Log Contrast Sensitivity Mesopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | 1.5 cycles per degree (cpd) | -1.769 log units | Standard Deviation 0.3251 |
| Control Product | Mean Monocular Distance Log Contrast Sensitivity Mesopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | 6 cycles per degree (cpd) | -1.628 log units | Standard Deviation 0.3382 |
| Control Product | Mean Monocular Distance Log Contrast Sensitivity Mesopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | 3 cycles per degree (cpd) | -1.868 log units | Standard Deviation 0.3196 |
Primary
Mean Monocular Distance Log Contrast Sensitivity Photopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
Contrast sensitivity (the ability to detect objects by distinguishing them from their background) was measured monocularly under photopic (well-lit) conditions with a glare source in log units using the Clinical Trial Suite (M&S Technologies) for sine-wave gratings 3, 6, 12, and 18 cycles per degree (CPD) at a test distance of 2.5 meters with best-corrected manifest refraction at 4 meters in place with an adjustment of +0.12 D for the 2.5-meter test distance. A more negative numeric log value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
Time frame: Month 12 (Day 360-420), post-first eye implantation
Population: Best Case Set - First Operative Eyes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FINEVISION HP | Mean Monocular Distance Log Contrast Sensitivity Photopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | 3 cycles per degree (cpd) | -1.632 log units | Standard Deviation 0.4171 |
| FINEVISION HP | Mean Monocular Distance Log Contrast Sensitivity Photopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | 6 cycles per degree (cpd) | -1.569 log units | Standard Deviation 0.3381 |
| FINEVISION HP | Mean Monocular Distance Log Contrast Sensitivity Photopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | 12 cycles per degree (cpd) | -1.175 log units | Standard Deviation 0.3928 |
| FINEVISION HP | Mean Monocular Distance Log Contrast Sensitivity Photopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | 18 cycles per degree (cpd) | -0.727 log units | Standard Deviation 0.4454 |
| Control Product | Mean Monocular Distance Log Contrast Sensitivity Photopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | 18 cycles per degree (cpd) | -0.956 log units | Standard Deviation 0.4332 |
| Control Product | Mean Monocular Distance Log Contrast Sensitivity Photopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | 3 cycles per degree (cpd) | -1.836 log units | Standard Deviation 0.3264 |
| Control Product | Mean Monocular Distance Log Contrast Sensitivity Photopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | 12 cycles per degree (cpd) | -1.357 log units | Standard Deviation 0.4015 |
| Control Product | Mean Monocular Distance Log Contrast Sensitivity Photopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | 6 cycles per degree (cpd) | -1.820 log units | Standard Deviation 0.3222 |
Primary
Mean Monocular Distance Log Contrast Sensitivity Photopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
Contrast sensitivity (the ability to detect objects by distinguishing them from their background) was measured monocularly under photopic (well-lit) conditions without glare source in log units using the Clinical Trial Suite (M&S Technologies) for sine-wave gratings 3, 6, 12, and 18 cycles per degree (CPD) at a test distance of 2.5 meters with best-corrected manifest refraction at 4 meters in place with an adjustment of +0.12 D for the 2.5-meter test distance. A more negative numeric log value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
Time frame: Month 12 (Day 360-420), post-first eye implantation
Population: Best Case Set - First Operative Eyes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FINEVISION HP | Mean Monocular Distance Log Contrast Sensitivity Photopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | 3 cycles per degree (cpd) | -1.998 log units | Standard Deviation 0.3003 |
| FINEVISION HP | Mean Monocular Distance Log Contrast Sensitivity Photopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | 6 cycles per degree (cpd) | -1.853 log units | Standard Deviation 0.2996 |
| FINEVISION HP | Mean Monocular Distance Log Contrast Sensitivity Photopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | 12 cycles per degree (cpd) | -1.419 log units | Standard Deviation 0.3558 |
| FINEVISION HP | Mean Monocular Distance Log Contrast Sensitivity Photopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | 18 cycles per degree (cpd) | -0.935 log units | Standard Deviation 0.3544 |
| Control Product | Mean Monocular Distance Log Contrast Sensitivity Photopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | 18 cycles per degree (cpd) | -1.149 log units | Standard Deviation 0.3822 |
| Control Product | Mean Monocular Distance Log Contrast Sensitivity Photopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | 3 cycles per degree (cpd) | -2.158 log units | Standard Deviation 0.2742 |
| Control Product | Mean Monocular Distance Log Contrast Sensitivity Photopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | 12 cycles per degree (cpd) | -1.608 log units | Standard Deviation 0.3723 |
| Control Product | Mean Monocular Distance Log Contrast Sensitivity Photopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5). | 6 cycles per degree (cpd) | -2.087 log units | Standard Deviation 0.2743 |
Primary
Mean Photopic Monocular logMAR Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters in First Operative Eyes
Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using the correction obtained from the manifest refraction and electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts on a CTS (Clinical Trial Suite, M&S Technologies) device at a distance of 4 meters (m) from the eye. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower or negative value represents better visual acuity. The mean logMAR values of the two groups were compared to demonstrate non-inferiority of FINEVISION HP trifocal IOL to the control IOL in mean photopic monocular logMAR BCDVA (best corrected distance visual acuity) for the first operative eyes.
Time frame: 150-180 days after surgery on the first eyes
Population: All-Implanted Analysis Set- First Operative Eyes with data available at the visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FINEVISION HP | Mean Photopic Monocular logMAR Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters in First Operative Eyes | 0.018 logMAR | Standard Error 0.005 |
| Control Product | Mean Photopic Monocular logMAR Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters in First Operative Eyes | -0.028 logMAR | Standard Error 0.0065 |
p-value: <0.000190% CI: [0.0316, 0.0592]t-test, 1 sided
Primary
Mean Photopic Monocular logMAR Distance Corrected Near Visual Acuity (DCNVA) for the First Operative Eyes.
VA was tested monocularly under photopic (well-lit) conditions using the manifest refraction adjusted for optical infinity and electronic ETDRS charts at a distance of 40 centimeters (cm) from the eye. Distance corrected visual acuity at near was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower value represents better visual acuity. The mean logMAR values of the two groups were compared to demonstrate superiority of FINEVISION HP trifocal IOL to the control in mean photopic monocular logMAR DCNVA for the first operative eyes.
Time frame: 150-180 days after surgery on the first eyes
Population: All-Implanted Analysis Set-First Operative Eyes with data at visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FINEVISION HP | Mean Photopic Monocular logMAR Distance Corrected Near Visual Acuity (DCNVA) for the First Operative Eyes. | 0.160 logMAR | Standard Error 0.0076 |
| Control Product | Mean Photopic Monocular logMAR Distance Corrected Near Visual Acuity (DCNVA) for the First Operative Eyes. | 0.551 logMAR | Standard Error 0.0111 |
p-value: <0.0001t-test, 2 sided
Primary
Percentage of 1st Operative Eyes With Secondary Surgical Interventions (SSIs) Related to Optical Properties of IOL for up to Month 12 (Visit 5)
The number of SSI's related to the optical properties of the IOL was calculated from the time of implantation up to Month 12. The percentage of SSIs was calculated as (# of first operative eyes with an SSI related to the optical properties of the IOL) divided by (# of first operative eyes with successful IOL implantation) times 100. The percentages were compared in the two groups to demonstrate noninferiority of FINEVISION HP IOL compared to AcrySof SN60AT IOL.
Time frame: Up to Month 12 (Day 360-420), post first eye implantation
Population: Safety Set (all eyes with successful IOL implantation) - First Operative Eyes
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| FINEVISION HP | Percentage of 1st Operative Eyes With Secondary Surgical Interventions (SSIs) Related to Optical Properties of IOL for up to Month 12 (Visit 5) | 1 Eyes |
| Control Product | Percentage of 1st Operative Eyes With Secondary Surgical Interventions (SSIs) Related to Optical Properties of IOL for up to Month 12 (Visit 5) | 0 Eyes |
90% CI: [-0.76, 1.36]
Secondary
Evaluate Visual Disturbances Using the Quality of Vision (QoV) Questionnaire and QoV Supplemental Questions at Month 12 (Visit 5)
The Quality of Vision (QoV) questionnaire was used to assess subjective visual disturbances reported by subjects receiving IOLs. The QoV asked the subject to rate the frequency, severity, and degree of bothersomeness for 10 items/visual disturbances in their everyday life based on the past week. The rating scales for frequency, severity, and degree of bothersomeness were: * Frequency: 0 (Never), 1 (Occasionally), 2 (Quite Often), 3 (Very Often) * Severity: 0 (Not at all), 1 (Mild), 2 (Moderate), 3 (Severe) * Bothersome: 0 (Not at all), 1 (A little), 2 (Quite), 3 (Very) Scores for each subscale (frequency, severity, degree of bothersomeness) ranging from 0 to 100, with higher scores indicating a higher degree of visual disturbances, were computed using a Rasch scoring algorithm which utilized data from the original validation of the QoV. Hypothesis testing was not planned for this outcome measure.
Time frame: Month 12 (Day 360-420), post-first eye implantation
Population: Safety Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FINEVISION HP | Evaluate Visual Disturbances Using the Quality of Vision (QoV) Questionnaire and QoV Supplemental Questions at Month 12 (Visit 5) | Frequency | 39.8 score on a scale | Standard Deviation 18.5 |
| FINEVISION HP | Evaluate Visual Disturbances Using the Quality of Vision (QoV) Questionnaire and QoV Supplemental Questions at Month 12 (Visit 5) | Severity | 31.8 score on a scale | Standard Deviation 16.25 |
| FINEVISION HP | Evaluate Visual Disturbances Using the Quality of Vision (QoV) Questionnaire and QoV Supplemental Questions at Month 12 (Visit 5) | Bothersomeness | 30.1 score on a scale | Standard Deviation 21.22 |
| Control Product | Evaluate Visual Disturbances Using the Quality of Vision (QoV) Questionnaire and QoV Supplemental Questions at Month 12 (Visit 5) | Frequency | 34.8 score on a scale | Standard Deviation 19.58 |
| Control Product | Evaluate Visual Disturbances Using the Quality of Vision (QoV) Questionnaire and QoV Supplemental Questions at Month 12 (Visit 5) | Severity | 29.3 score on a scale | Standard Deviation 17.4 |
| Control Product | Evaluate Visual Disturbances Using the Quality of Vision (QoV) Questionnaire and QoV Supplemental Questions at Month 12 (Visit 5) | Bothersomeness | 28.8 score on a scale | Standard Deviation 21.45 |
Secondary
Mean Photopic Monocular logMAR Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm for the First Operative Eyes.
VA was tested monocularly under photopic(well-lit) conditions using the manifest refraction adjusted for optical infinity and electronic ETDRS charts at a distance of 66 centimeters (cm) from the eye. DCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower value represents better visual acuity. The mean logMAR values of the two groups were compared to demonstrate superiority of FINEVISION HP trifocal IOL to the control in mean photopic monocular logMAR DCIVA for the first operative eyes.
Time frame: 150-180 days after surgery on the first eye
Population: All-Implanted Analysis Set- First Operative Eyes with data at visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FINEVISION HP | Mean Photopic Monocular logMAR Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm for the First Operative Eyes. | 0.161 logMAR | Standard Error 0.0063 |
| Control Product | Mean Photopic Monocular logMAR Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm for the First Operative Eyes. | 0.342 logMAR | Standard Error 0.0102 |
p-value: <0.0001t-test, 2 sided
Secondary
Number and Percentage of First Operative Eyes With Cumulative and Persistent Adverse Events at Month 12 (Visit 5) in Comparison to the ISO Safety and Performance Endpoint (SPE) Rates as Described in ISO 11979-7
The number and percentage of the first operative eyes with cumulative and persistent adverse events as noted in ISO 11979-7 were calculated for the two IOL groups and compared with the ISO Safety and Performance Endpoint (SPE) rates from ISO 11979-7 Table E.2. A p-value was calculated for each adverse event for each IOL group to determine the statistical significance of the difference in the percentages.
Time frame: Month 12 (Day 360-420), post-first eye implantation
Population: Safety Set - First Operative Eyes
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| FINEVISION HP | Number and Percentage of First Operative Eyes With Cumulative and Persistent Adverse Events at Month 12 (Visit 5) in Comparison to the ISO Safety and Performance Endpoint (SPE) Rates as Described in ISO 11979-7 | Cumulative : Lens dislocated from posterior chamber | 0 Eyes |
| FINEVISION HP | Number and Percentage of First Operative Eyes With Cumulative and Persistent Adverse Events at Month 12 (Visit 5) in Comparison to the ISO Safety and Performance Endpoint (SPE) Rates as Described in ISO 11979-7 | Cumulative : Secondary surgical intervention | 6 Eyes |
| FINEVISION HP | Number and Percentage of First Operative Eyes With Cumulative and Persistent Adverse Events at Month 12 (Visit 5) in Comparison to the ISO Safety and Performance Endpoint (SPE) Rates as Described in ISO 11979-7 | Cumulative : Endophthalmitis | 0 Eyes |
| FINEVISION HP | Number and Percentage of First Operative Eyes With Cumulative and Persistent Adverse Events at Month 12 (Visit 5) in Comparison to the ISO Safety and Performance Endpoint (SPE) Rates as Described in ISO 11979-7 | Persistent: Corneal stroma oedema | 0 Eyes |
| FINEVISION HP | Number and Percentage of First Operative Eyes With Cumulative and Persistent Adverse Events at Month 12 (Visit 5) in Comparison to the ISO Safety and Performance Endpoint (SPE) Rates as Described in ISO 11979-7 | Cumulative : Pupillary block | 0 Eyes |
| FINEVISION HP | Number and Percentage of First Operative Eyes With Cumulative and Persistent Adverse Events at Month 12 (Visit 5) in Comparison to the ISO Safety and Performance Endpoint (SPE) Rates as Described in ISO 11979-7 | Persistent: Cystoid macular oedema | 0 Eyes |
| FINEVISION HP | Number and Percentage of First Operative Eyes With Cumulative and Persistent Adverse Events at Month 12 (Visit 5) in Comparison to the ISO Safety and Performance Endpoint (SPE) Rates as Described in ISO 11979-7 | Cumulative : Hypopyon | 0 Eyes |
| FINEVISION HP | Number and Percentage of First Operative Eyes With Cumulative and Persistent Adverse Events at Month 12 (Visit 5) in Comparison to the ISO Safety and Performance Endpoint (SPE) Rates as Described in ISO 11979-7 | Persistent: Iritis | 1 Eyes |
| FINEVISION HP | Number and Percentage of First Operative Eyes With Cumulative and Persistent Adverse Events at Month 12 (Visit 5) in Comparison to the ISO Safety and Performance Endpoint (SPE) Rates as Described in ISO 11979-7 | Cumulative : Retinal detachment | 3 Eyes |
| FINEVISION HP | Number and Percentage of First Operative Eyes With Cumulative and Persistent Adverse Events at Month 12 (Visit 5) in Comparison to the ISO Safety and Performance Endpoint (SPE) Rates as Described in ISO 11979-7 | Persistent: Raised Intraocular Pressure (IOP) requiring treatment | 0 Eyes |
| FINEVISION HP | Number and Percentage of First Operative Eyes With Cumulative and Persistent Adverse Events at Month 12 (Visit 5) in Comparison to the ISO Safety and Performance Endpoint (SPE) Rates as Described in ISO 11979-7 | Cumulative : Cystoid macular oedema | 1 Eyes |
| Control Product | Number and Percentage of First Operative Eyes With Cumulative and Persistent Adverse Events at Month 12 (Visit 5) in Comparison to the ISO Safety and Performance Endpoint (SPE) Rates as Described in ISO 11979-7 | Persistent: Raised Intraocular Pressure (IOP) requiring treatment | 0 Eyes |
| Control Product | Number and Percentage of First Operative Eyes With Cumulative and Persistent Adverse Events at Month 12 (Visit 5) in Comparison to the ISO Safety and Performance Endpoint (SPE) Rates as Described in ISO 11979-7 | Cumulative : Cystoid macular oedema | 1 Eyes |
| Control Product | Number and Percentage of First Operative Eyes With Cumulative and Persistent Adverse Events at Month 12 (Visit 5) in Comparison to the ISO Safety and Performance Endpoint (SPE) Rates as Described in ISO 11979-7 | Cumulative : Hypopyon | 0 Eyes |
| Control Product | Number and Percentage of First Operative Eyes With Cumulative and Persistent Adverse Events at Month 12 (Visit 5) in Comparison to the ISO Safety and Performance Endpoint (SPE) Rates as Described in ISO 11979-7 | Cumulative : Endophthalmitis | 0 Eyes |
| Control Product | Number and Percentage of First Operative Eyes With Cumulative and Persistent Adverse Events at Month 12 (Visit 5) in Comparison to the ISO Safety and Performance Endpoint (SPE) Rates as Described in ISO 11979-7 | Cumulative : Lens dislocated from posterior chamber | 0 Eyes |
| Control Product | Number and Percentage of First Operative Eyes With Cumulative and Persistent Adverse Events at Month 12 (Visit 5) in Comparison to the ISO Safety and Performance Endpoint (SPE) Rates as Described in ISO 11979-7 | Cumulative : Pupillary block | 0 Eyes |
| Control Product | Number and Percentage of First Operative Eyes With Cumulative and Persistent Adverse Events at Month 12 (Visit 5) in Comparison to the ISO Safety and Performance Endpoint (SPE) Rates as Described in ISO 11979-7 | Cumulative : Retinal detachment | 0 Eyes |
| Control Product | Number and Percentage of First Operative Eyes With Cumulative and Persistent Adverse Events at Month 12 (Visit 5) in Comparison to the ISO Safety and Performance Endpoint (SPE) Rates as Described in ISO 11979-7 | Cumulative : Secondary surgical intervention | 1 Eyes |
| Control Product | Number and Percentage of First Operative Eyes With Cumulative and Persistent Adverse Events at Month 12 (Visit 5) in Comparison to the ISO Safety and Performance Endpoint (SPE) Rates as Described in ISO 11979-7 | Persistent: Corneal stroma oedema | 0 Eyes |
| Control Product | Number and Percentage of First Operative Eyes With Cumulative and Persistent Adverse Events at Month 12 (Visit 5) in Comparison to the ISO Safety and Performance Endpoint (SPE) Rates as Described in ISO 11979-7 | Persistent: Cystoid macular oedema | 1 Eyes |
| Control Product | Number and Percentage of First Operative Eyes With Cumulative and Persistent Adverse Events at Month 12 (Visit 5) in Comparison to the ISO Safety and Performance Endpoint (SPE) Rates as Described in ISO 11979-7 | Persistent: Iritis | 0 Eyes |
p-value: >0.05One-sided exact binomial test
p-value: >0.05One-sided exact binomial test
p-value: >0.05One-sided exact binomial test
p-value: >0.05One-sided exact binomial test
p-value: >0.05One-sided exact binomial test
p-value: >0.05One-sided exact binomial test
p-value: >0.05One-sided exact binomial test
p-value: >0.05One-sided exact binomial test
p-value: >0.05One-sided exact binomial test
p-value: >0.05One-sided exact binomial test
p-value: >0.05One-sided exact binomial test
p-value: >0.05One-sided exact binomial test
p-value: >0.05One-sided exact binomial test
p-value: >0.05One-sided exact binomial test
p-value: >0.05One-sided exact binomial test
p-value: >0.05One-sided exact binomial test
p-value: >0.05One-sided exact binomial test
p-value: >0.05One-sided exact binomial test
p-value: >0.05One-sided exact binomial test
p-value: >0.05One-sided exact binomial test
p-value: >0.05One-sided exact binomial test
p-value: >0.05One-sided exact binomial test