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

Alcon, a Novartis Company104 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

SINGLE

Enrollment

104

Conditions

Pseudophakia

Interventions

Acrylic IOLDEVICE

Acrylic IOL for long-term implantation in the cataract patient

Silicone IOLDEVICE

Silicone IOL for long-term implantation in the cataract patient

PMMA IOLDEVICE

Polymethylmethacrylate IOL for long-term implantation in the cataract patient

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Baseline (up to and including 3 months after implantation), long-term post-implantation visit (14-20 years after implantation)

Data from ClinicalTrials.gov

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