Evaluation of Glistenings in Intraocular Lenses Implanted in Normal Patients Following Routine Cataract Extraction. (AVS Vs MA50BM)

September 14, 2015 updated by: Fry Eye Associates and Fry Eye Surgery Center

Evaluation of Glistenings in Intraocular Lenses AVS Model X-60 Vs AcrySof MA50-BM.

Evaluation of glistenings in intraocular lenses implanted in normal patients following routine cataract surgery. The lenses used will be Model X-60 made by the AVS company Vs AcrySof MA50BM made by the Alcon company.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Garden City, Kansas, United States, 67846
        • Fry Eye Associates

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years or older
  • Bilateral cataracts requiring surgery
  • Potential visual acuity of 20/40 or better in both eyes
  • Require IOL power in range of 15-25 diopters
  • Pupillary dilation of at least 6mm
  • Willing and able to provide informed consent and attend follow-up appointments to 3 years

Exclusion Criteria:

  • Any co-existing ocular disease or previous ocular surgery that would confound findings in the study, especially those effecting quality of vision. Examples include Macular degeneration amblyopia and prior epiretinal membrane peel.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: AcrySof MA50BM,AVS Model X-60
AcrySof MA50BM, AVS Model X-60
Device: Intraocular lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Glistenings between the Model X-60 made by the AVS company and AcrySof MA50BM made by the Alcon company.
Time Frame: The patient will be followed 1-2 days after surgery on the first eye and 1-2 days after surgery on the second eye,1-2 months after surgery on both eyes,4-6 months after surgery on both eyes and 1,2 and 3 yrs after surgery on both eyes.
Each patient will have the same testing at each visit. Photos will be taken of the glistenings,sent off and counted.
The patient will be followed 1-2 days after surgery on the first eye and 1-2 days after surgery on the second eye,1-2 months after surgery on both eyes,4-6 months after surgery on both eyes and 1,2 and 3 yrs after surgery on both eyes.

Collaborators and Investigators

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

Sponsor

Fry Eye Associates and Fry Eye Surgery Center

Collaborators

Bausch & Lomb Incorporated

Investigators

  • Principal Investigator: Luther Fry, MD, Fry Eye Associates

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, 2010

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

July 1, 2013

Study Registration Dates

First Submitted

May 26, 2010

First Submitted That Met QC Criteria

May 26, 2010

First Posted (Estimate)

May 27, 2010

Study Record Updates

Last Update Posted (Estimate)

September 15, 2015

Last Update Submitted That Met QC Criteria

September 14, 2015

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol Number 7248

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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