Corrected VA With Long-Term Follow-Up After AcrySof® Intraocular Lens (IOL) Implantation

Study Overview
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Brief Summary
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The purpose of this study is to compare the long-term visual acuity (VA) with an acrylic IOL to a silicone or polymethylmethacrylate (PMMA) IOL in cataract patients. This study will take place in Japan.

Official Title
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Corrected VA With Long-Term Follow-Up After AcrySof® IOL Implantation

Conditions
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Pseudophakia

Intervention / Treatment
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* Device: Acrylic IOL
* Device: Silicone IOL
* Device: PMMA IOL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing to provide voluntary consent and able to comprehend and sign the informed consent form; Pseudophakic patients implanted with an Acrylic (AcrySof®), PMMA or silicone IOL from 1994 to 2000; Clear intraocular media in study eye; Best-corrected visual acuity (decimal) within 3 months post-implantation of 0.8 (decimal VA chart) or more in study eye; No ocular or systemic condition which may affect visual acuity in study eye; Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Complications that may impact visual acuity in study eye at the time of the prospective visit, such as glaucoma, diabetic retinitis, ocular inflammatory disease, retinal detachment, and others as specified in the protocol; Previous refractive surgery in study eye; Previous IOL exchange in study eye; Other protocol-specified exclusion criteria may apply.
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

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AcrySof IOL<br>Acrylic IOL, prior implantation (1994-2000) in one or both eyes | Device: Acrylic IOL<br>* Acrylic IOL for long-term implantation in the cataract patient<br>* Other names: AcrySof® Model MA60BM;|
| Active Comparator: Silicone IOL<br>Silicone IOL, prior implantation (1994-2000) in one or both eyes | Device: Silicone IOL<br>* Silicone IOL for long-term implantation in the cataract patient<br>|
| Active Comparator: PMMA IOL<br>PMMA IOL, prior implantation (1994-2000) in one or both eyes | Device: PMMA IOL<br>* Polymethylmethacrylate IOL for long-term implantation in the cataract patient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at the Long-Term, Post-Implantation Visit | Measurement of best corrected (with spectacles or other visual corrective devices) visual acuity (at both near and distance). Visual Acuity (VA) is measured in logMAR (logarithm of the minimum angle of resolution). A lower logMAR value indicates better visual acuity. One eye (study eye) contributed to the analysis. | Baseline (up to and including 3 months after implantation), long-term post-implantation visit (14-20 years after implantation) |