Evaluation of 3 Intraocular Lenses Following Lens Extraction

Study Overview
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Brief Summary
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The objective of this study is to evaluate the efficacy and subject satisfaction with three different FDA approved lenses for adults over 40 years of age who desire a reduction in spectacle dependence.

Official Title
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A Three Arm Prospective Clinical Evaluation of Three FDA Approved Intraocular Lenses Designed to Improve Distance, Intermediate and Near Vision Following Lens Extraction.

Conditions
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Cataract

Intervention / Treatment
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* Device: Crystalens AO
* Device: ReSTOR
* Device: Tecnis Multifocal IOL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must have a clinically documented diagnosis of age-related bilateral cataracts that are considered amenable to treatment with standard phacoemulsification cataract extraction. Subjects must require a spherical lens power from 10.00 D to 33.00 D Subjects must have the potential for corrected distance visual acuity (CDVA) of 20/32 or better in both eyes, as documented by a Potential Acuity Meter Exclusion Criteria: Subjects with conditions with increased risk of zonular rupture, such as pseudoexfoliation syndrome. Zonular rupture during cataract surgery may affect postoperative centration, tilt, and stability of the lens. Subjects who have any active inflammation or edema (swelling) of the cornea, including but not limited to the following: keratitis, keratoconjunctivitis, and keratouveitis. Subjects with visually significant diabetic retinopathy (proliferative or non-proliferative) which reduces potential acuity to 20/32 or worse.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Crystalens AO<br>Eligible subjects to undergo small incision cataract surgery and were implanted with the Crystalens AO bilaterally. | Device: Crystalens AO<br>* Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.<br>|
| Active Comparator: ReSTOR<br>Eligible subjects to undergo small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. | Device: ReSTOR<br>* ReSTOR surgically implanted bilaterally. Study observation up to 180 days.<br>|
| Active Comparator: Tecnis Multifocal IOL<br>Eligible subjects to undergo small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. | Device: Tecnis Multifocal IOL<br>* Tecnis surgically implanted bilaterally. Study observation up to 180 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Postoperative visit 3 (2-3 months) | 
| Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Postoperative visit 3 (2-3 months) | 
| Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Postoperative visit 3 (2-3 months) | 
| Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Postoperative visit 3 (2-3 months) | 
| Mesopic Monocular Contrast Sensitivity Without Glare 1.5 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Postoperative visit 4 ( 4-6 months) | 
| Mesopic Monocular Contrast Sensitivity Without Glare 3 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Postoperative visit 4 ( 4-6 months) | 
| Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Postoperative visit 4 ( 4-6 months) | 
| Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Postoperative visit 4 ( 4-6 months) | 
| Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Postoperative visit 4 ( 4-6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binocular Mesopic Contrast Sensitivity Without Glare 1.5 & 3 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 3 (2-3 months) | 
| Binocular Mesopic Contrast Sensitivity Without Glare 6 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 3 (2-3 months) | 
| Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 3 (2-3 months) | 
| Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 3 (2-3 months) | 
| Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 4 (4-6 months) | 
| Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 4 (4-6 months) | 
| Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 4 (4-6 months) | 
| Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 3 (2-3 months) | 
| Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 3 (2-3 months) | 
| Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 3 (2-3 months) | 
| Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 3 (2-3 months) | 
| Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 3 (2-3 months) | 
| Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 4 (4-6 months) | 
| Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 4 (4-6 months) | 
| Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 4 (4-6 months) | 
| Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 4 (4-6 months) | 
| Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 4 (4-6 months) | 
| Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 3 (2-3 months) | 
| Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 3 (2-3 months) | 
| Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 3 (2-3 months) | 
| Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 3 (2-3 months) | 
| Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 4 (4-6 months) | 
| Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 4 (4-6 months) | 
| Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 4 (4-6 months) | 
| Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 4 (4-6 months) | 
| Optical Scatter | Objective scatter index (OSI) was assessed using the Optical Quality Analysis System(OQAS) and summarized as a continuous variable. For this assessment, an OSI score of 1 or less represents good quality vision, 1-2 indicates some degradation but otherwise normal vision, 2-3 significant light scatter possibly requiring treatment, and scores over 4 severely compromised vision requiring intervention. | Visit 3 (2-3 months) | 
| Optical Scatter | Objective scatter index (OSI) was assessed using the Optical Quality Analysis System(OQAS) and summarized as a continuous variable. For this assessment, an OSI score of 1 or less represents good quality vision, 1-2 indicates some degradation but otherwise normal vision, 2-3 significant light scatter possibly requiring treatment, and scores over 4 severely compromised vision requiring intervention. | Visit 4 (4-6 months) | 
| Monocular Halo and Starburst | Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome. | Visit 3 (2-3 months) | 
| Monocular Halo and Starburst | Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome. | Visit 4 (4-6 months) | 
| Binocular Halo and Starburst | Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome. | Visit 3 (2-3 months) | 
| Binocular Halo and Starburst | Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome. | Visit 4 (4-6 months) | 
| Manifest Refraction | Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder. | Visit 3 (2-3 Months) | 
| Manifest Refraction | Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder. | Visit 4 (4-6 Months) | 
| Uncorrected Distance Visual Acuity | High Contrast Uncorrected Distance (UCDVA) measured at 32 inches, Intermediate (UCIVA) at 32 inches, and Near Visual Acuity (UCNVA) at 16 inches | Visit 3 (2-3 months) Visit 4 (4-6 months) | 
| Best-corrected Distance Visual Acuity | High Contrast Distance-Corrected Distance,(BCDVA), Intermediate (DCIVA), and Near Visual Acuity (DCNVA) | Visit 3 (2-3 months) Visit 4 (4-6 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intra Ocular Lens, Ocular surgery, Phacoemulsification