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

October 17, 2016 updated by: Alcon, a Novartis Company

Corrected VA With Long-Term Follow-Up After AcrySof® 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AcrySof IOL
Acrylic IOL, prior implantation (1994-2000) in one or both eyes
Device: Acrylic IOL
Acrylic IOL for long-term implantation in the cataract patient
Other Names:
  • AcrySof® Model MA30BA
  • AcrySof® Model MA60BM
Active Comparator: Silicone IOL
Silicone IOL, prior implantation (1994-2000) in one or both eyes
Device: Silicone IOL
Silicone IOL for long-term implantation in the cataract patient
Active Comparator: PMMA IOL
PMMA IOL, prior implantation (1994-2000) in one or both eyes
Device: PMMA IOL
Polymethylmethacrylate IOL for long-term implantation in the cataract patient

What is the study measuring?

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon, a Novartis Company

Investigators

  • Study Director: Group Manager, Clinical Dev., Alcon Japan, Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

May 19, 2015

First Submitted That Met QC Criteria

May 19, 2015

First Posted (Estimate)

May 21, 2015

Study Record Updates

Last Update Posted (Estimate)

December 9, 2016

Last Update Submitted That Met QC Criteria

October 17, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILQ245-P001
  • UMIN000017727 (Other Identifier: UMIN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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