Evaluation of Glistenings in Intraocular Lenses Implanted in Normal Patients Following Routine Cataract Extraction.

NCT ID: NCT01131481

Last Updated: 2015-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Glistenings

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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AcrySof MA50BM,AVS Model X-60

AcrySof MA50BM, AVS Model X-60

Group Type OTHER

Intraocular lens

Intervention Type DEVICE

Interventions

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Intraocular lens

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role collaborator

Fry Eye Associates and Fry Eye Surgery Center

OTHER

Sponsor Role lead

Responsible Party

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Fry Eye Associates and Fry Eye Surgery Center

Principal Investigators

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Luther Fry, MD

Role: PRINCIPAL_INVESTIGATOR

Fry Eye Associates

Locations

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Fry Eye Associates

Garden City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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Protocol Number 7248

Identifier Type: -

Identifier Source: org_study_id

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