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OpenTrials
Completed

NCT Number: NCT00595543

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

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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Key information

Conditions

Acute Pseudophakic Cystoid Macular Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Soll Eye Associates

Philadelphia, Pennsylvania, 19124, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bromfenac

Drug

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

Ketorolac

Drug

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

Diclofenac

Drug

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

Primary outcomes

  1. Acute Pseudophakic Cystoid Macular Edema

    Time frame: 5 months

Secondary outcomes

  1. Visual Acuity

    Time frame: 5 months

Sponsors and collaborators

Lead sponsor

Bp Consulting, Inc

Network

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 16, 2008
Registry last updated
Mar 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.