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OpenTrials
Completed

NCT Number: NCT02450799

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

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.

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Key information

Conditions

Pseudophakia Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acrylic IOL

Device

Acrylic IOL for long-term implantation in the cataract patient

Other names: AcrySof® Model MA30BA, AcrySof® Model MA60BM

Silicone IOL

Device

Silicone IOL for long-term implantation in the cataract patient

PMMA IOL

Device

Polymethylmethacrylate IOL for long-term implantation in the cataract patient

Primary outcomes

  1. Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at the Long-Term, Post-Implantation Visit

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alcon, a Novartis Company

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 21, 2015
Registry last updated
Dec 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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