Efficacy of Topical Ketorolac Versus Placebo for Improving Visual Outcomes Following Multifocal IOL Implantation

NCT ID: NCT00433225

Last Updated: 2007-09-10

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

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study was to evaluate the efficacy of ketorolac 0.4% on quality of vision and macula thickening in patients undergoing cataract surgery using the ReStor® multifocal IOL.

Detailed Description

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Conditions

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Macula Thickening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Interventions

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Prednisolone Acetate

Intervention Type DRUG

Ketorolac 0.4%

Intervention Type DRUG

Gatifloxacin 0.3%

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males or females \> 50 years old
* Scheduled to undergo bilateral phacoemulsification with implantation of a multifocal IOL.
* Likely to complete all study visits and able to provide informed consent
* Visual potential of 20/25 or better

Exclusion Criteria

* · Prior use of topical ketorolac

* Known contraindications to any study medication or ingredients
* Active ocular diseases or uncontrolled systemic disease
* Active ocular allergies
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Innovative Medical

INDUSTRY

Sponsor Role lead

Principal Investigators

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Eric Donnenfeld

Role: PRINCIPAL_INVESTIGATOR

Ophthalmic Consultants of Long Island

Locations

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Ophthalmic Consultants of Long Island

Rockville Centre, New York, United States

Site Status

Countries

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United States

Other Identifiers

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5293

Identifier Type: -

Identifier Source: org_study_id