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

This study has been completed.
Information provided by:
Bp Consulting, Inc Identifier:
First received: January 7, 2008
Last updated: March 17, 2009
Last verified: March 2009
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.

Condition Intervention Phase
Acute Pseudophakic Cystoid Macular Edema Drug: Bromfenac Drug: Ketorolac Drug: Diclofenac Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Bp Consulting, Inc:

Primary Outcome Measures:
  • Acute Pseudophakic Cystoid Macular Edema [ Time Frame: 5 months ]

Secondary Outcome Measures:
  • Visual Acuity [ Time Frame: 5 months ]

Estimated Enrollment: 166
Study Start Date: January 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Bromfenac
1 drop (in the eye) Instill one drop in the affected eye twice daily for three months
Active Comparator: 2 Drug: Ketorolac
1 drop (in the eye) Instill one drop in the affected eye four times daily for three months
Active Comparator: 3 Drug: Diclofenac
1 drop (in the eye) Instill one drop in the affected eye four times daily for three months


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00595543

United States, Pennsylvania
Soll Eye Associates
Philadelphia, Pennsylvania, United States, 19124
Sponsors and Collaborators
Bp Consulting, Inc
Principal Investigator: David Rho, MD Soll Eye Associates
  More Information

Responsible Party: David Rho, MD, Soll Eye Associates Identifier: NCT00595543     History of Changes
Other Study ID Numbers: 5349
Study First Received: January 7, 2008
Last Updated: March 17, 2009

Additional relevant MeSH terms:
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 18, 2017