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

Bp Consulting

Status and phase: Completed; Phase 4

Conditions: Acute Pseudophakic Cystoid Macular Edema

Treatments: Drug: Ketorolac; Drug: Bromfenac; Drug: Diclofenac

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00595543

5349

Details and patient eligibility

About

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.

Enrollment: 166 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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166 participants in 3 patient groups

1

Active Comparator group

Treatment:

Drug: Bromfenac

2

Active Comparator group

Treatment:

Drug: Ketorolac

3

Active Comparator group

Treatment:

Drug: Diclofenac