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

Phase 4

Completed

• Conditions: Acute Pseudophakic Cystoid Macular Edema
• Interventions: Drug: Ketorolac; Drug: Bromfenac; Drug: Diclofenac

• Registration Number: NCT00595543
• Lead Sponsor: Bp Consulting, Inc

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-07
• Study First Submitted QC: 2008-01-15
• Study First Posted: 2008-01-16
• Status Verified: 2009-03
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Last Update Submitted: 2009-03-17
• Last Update Posted: 2009-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Ketorolac	-
1	Bromfenac	-
3	Diclofenac	-

Primary Outcome Measures

Name	Time	Method
Acute Pseudophakic Cystoid Macular Edema	5 months

Secondary Outcome Measures

Name	Time	Method
Visual Acuity	5 months

Trial Locations

Locations (1)

Soll Eye Associates; 🇺🇸 Philadelphia, Pennsylvania, United States