Treatment of Acute Pseudophakic Cystoid Macular Edema: Bromfenac 0.09% Versus Diclofenac Sodium 0.1% Versus Ketorolac Tromethamine 0.5%

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

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-03-31

Brief Summary

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To compare bromfenac 0.09%, diclofenac sodium 0.1%, and ketorolac tromethamine 0.5% ophthalmic solutions for the treatment of acute pseudophakic CME after cataract surgery.

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Detailed Description

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Conditions

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Acute Pseudophakic Cystoid Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Bromfenac

Intervention Type DRUG

1 drop (in the eye) Instill one drop in the affected eye twice daily for three months

2

Group Type ACTIVE_COMPARATOR

Ketorolac

Intervention Type DRUG

1 drop (in the eye) Instill one drop in the affected eye four times daily for three months

3

Group Type ACTIVE_COMPARATOR

Diclofenac

Intervention Type DRUG

1 drop (in the eye) Instill one drop in the affected eye four times daily for three months

Interventions

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Bromfenac

1 drop (in the eye) Instill one drop in the affected eye twice daily for three months

Intervention Type DRUG

Ketorolac

1 drop (in the eye) Instill one drop in the affected eye four times daily for three months

Intervention Type DRUG

Diclofenac

1 drop (in the eye) Instill one drop in the affected eye four times daily for three months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients must be diagnosed with acute pseudophakic CME within 12 months of cataract surgery
* Males and females 18 years and older
* Able to provide written informed consent

Exclusion Criteria

* Complicated cataract surgery, particularly posterior capsule rupture and vitreous loss
* Pre-Existing macular pathology, including macular edema, macular scar, macular hole, or macular pucker
* History of Uveitis
* Ipsilateral intraocular surgery prior to cataract surgery
* CME greater than one year duration

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No