Three Intraocular Lenses Designed to Improve Distance, Intermediate and Near Vision Following Lens Extraction

Study Overview
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Brief Summary
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The objective of this study is to compare the contrast sensitivity, high and low contrast visual acuity (VA), glare meter outcomes, and subject satisfaction with three different FDA-approved intraocular lenses (IOLs) designed to improve distance, intermediate, and near vision following lens extraction in adults at least 40 years of age.

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 3.0
* Device: AMO Tecnis Multifocal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be undergoing primary IOL implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction. Subjects must require a spherical lens power from 10.00 diopters (D) to 33.00 D. Subjects must have the potential for corrected distance visual acuity (CDVA) of 20/32 or better in both eyes. Subjects must have stopped contact lens wear for at least two weeks for soft lens wearers or three weeks for gas permeable lens wearers prior to biometry and surgery. At the time of surgery, subjects must have an intact centered capsulorhexis, intact posterior capsule, and no zonular rupture. Subjects must have ≤ 1.25 D of preoperative corneal astigmatism in both eyes. Exclusion Criteria: Subjects with diagnoses of degenerative visual disorders (eg, macular degeneration, or other retinal disorders) that cause potential acuity losses to a level of 20/32 or worse. Subjects with conditions with increased risk of zonular rupture, such as pseudoexfoliation syndrome. 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 uncontrolled glaucoma. Subjects with previous retinal detachment. Subjects with visually significant diabetic retinopathy (proliferative or nonproliferative) which reduces potential acuity to 20/32 or worse. Subjects with rubella, bilateral congenital, traumatic, complicated or polar cataract. Subjects with marked microphthalmos or aniridia. Subjects who have had previous corneal surgery. Subjects with irregular corneal astigmatism. Subjects with amblyopia which reduces potential acuity to 20/32 or worse. Subjects with optic atrophy. Subjects with iris neovascularization. Subjects with clinically significant retinal pigment epithelium/macular changes which reduces potential acuity to 20/32 or worse. Subjects with chronic use of systemic steroids or immunosuppressive medications.

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>Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens | Device: Crystalens AO<br>* Bausch & Lomb model silicone multi-piece accommodating IOL.<br>|
| Active Comparator: ReSTOR 3.0<br>An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region. | Device: ReSTOR 3.0<br>* An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.<br>|
| Active Comparator: AMO Tecnis Multifocal<br>A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL | Device: AMO Tecnis Multifocal<br>* The Tecnis Multifocal foldable hydrophobic acrylic IOL, Model ZMA00 (Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocular Mesopic Contrast Sensitivity Without Glare (1.5, 3 Cycles/Degree) | A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 3 (day 30-60) | 
| Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) | A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 3 (day 30-60) | 
| Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) | A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 3 (day 30-60) | 
| Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) | A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 3 (day 30-60) | 
| Monocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) | A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 4 (day 120-180) | 
| Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) | A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 4 (day 120-180) | 
| Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) | A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 4 (day 120-180) | 
| Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) | A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 4 (day 120-180) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) | In two eye (Binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 3 (day 30-60) | 
| Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) | In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 3 (day 30-60) | 
| Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) | In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 3 (day 30-60) | 
| Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) | In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 3 (day 30-60) | 
| Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) | In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 4 (day 120-180) | 
| Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) | In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 4 (day 120-180) | 
| Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) | In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 4 (day 120-180) | 
| Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) | In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 4 (day 120-180) | 
| Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 3 (day 30-60) | 
| Monocular Mesopic Contrast Sensitivity With Glare (3 Cycles/Degree) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 3 (day 30-60) | 
| Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 3 (day 30-60) | 
| Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 3 (day 30-60) | 
| Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 3 (day 30-60) | 
| Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 4 (day 120-180) | 
| Monocular Mesopic Contrast Sensitivity With Glare(3 Cycles/Degree) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 4 (day 120-180) | 
| Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 4 (day 120-180) | 
| Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 4 (day 120-180) | 
| Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 4 (day 120-180) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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phacoemulsification, intraocular lens