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

Not Applicable

Completed

• Conditions: Pseudophakia
• Interventions: Device: PMMA IOL; Device: Silicone IOL; Device: Acrylic IOL

• Registration Number: NCT02450799
• Lead Sponsor: Alcon, a Novartis Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-19
• Study First Submitted QC: 2015-05-19
• Study First Posted: 2015-05-21
• Study Start: 2015-06
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-10
• Results First Submitted: 2016-10-17
• Results First Submitted QC: 2016-10-17
• Last Update Submitted: 2016-10-17
• Results First Posted: 2016-12-09
• Last Update Posted: 2016-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PMMA IOL	PMMA IOL	PMMA IOL, prior implantation (1994-2000) in one or both eyes
Silicone IOL	Silicone IOL	Silicone IOL, prior implantation (1994-2000) in one or both eyes
AcrySof IOL	Acrylic IOL	Acrylic IOL, prior implantation (1994-2000) in one or both eyes

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at the Long-Term, Post-Implantation Visit	Baseline (up to and including 3 months after implantation), long-term post-implantation visit (14-20 years after implantation)	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.