This study is a prospective, multicenter, randomized, double masked confirmatory trial comparing an investigational trifocal intraocular lens (IOL) and a commercially available monofocal IOL.
The study will include adult subjects with operable cataracts in both eyes who are eligible for phacoemulsification cataract surgery followed by IOL implantation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
539
Cataractous lens will be removed in the study eyes and the FINEVISION HP IOL will be implanted in the capsular bag.
Cataractous lens will be removed in the study eyes and the Alcon AcrySof SN60AT IOL will be implanted in the capsular bag.
Mitchell C Shultz MD/Shultz Chang Vision
Northridge, California, United States
Coastal Vision Medical Group
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
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
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.
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Orange, California, United States
Arbor Centers for Eye Care
Orland Park, Illinois, United States
Michael Washburn Center for Ophthalmic Research
Indianapolis, Indiana, United States
Vance Thompson Vision, MN Site
Alexandria, Minnesota, United States
Chu Vision Institute
Bloomington, Minnesota, United States
Ophthalmology Consultants, Ltd
St Louis, Missouri, United States
Vance Thompson Vision, MT Site
Bozeman, Montana, United States
Vance Thompson Vision NE Site
Omaha, Nebraska, United States
Center For Sight
Las Vegas, Nevada, United States
...and 10 more locations
Time frame: Up to Month 12 (Day 360-420), post first eye implantation
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
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
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
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
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
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
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