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Completed

NCT Number: NCT00469781

Bromfenac BID Plus Prednisolone Acetate BID Versus Bromfenac BID Plus Prednisolone QID for the Prevention of Cystoid Macular Edema and Retinal Thickening

The objective of this study is to determine if twice-daily dosing of prednisolone (Pred Forte) is as effective as four-times-daily dosing of prednisolone for the prevention of retinal thickening and cystoid macular edema (CME) when either regimen is used concomitantly with twice-daily bromfenac.

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Key information

Conditions

Cystoid Macular Edema, Eye Diseases Macular Degeneration Macular Edema Retinal Degeneration Retinal Diseases Retinal Thickening

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Center for Excellence in Eye Care

Miami, Florida, 33176, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • · Male or female > 18 years of age scheduled to undergo cataract surgery
  • Must be in good general health. Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (ie diabetics with normal retinal exams)
  • Expected visual outcome of 20/25 or better.
  • Ability to provide informed consent and likely to complete all study visits

Exclusion criteria

  • · Known contraindication to any study medication or any of their components
  • Uncontrolled systemic disease
  • Required use of ocular medications other than the study medications during the study
  • Abnormal pre-operative OCTs
  • Diabetic patients with a history of macular edema or diabetic retinopathy
  • AMD, epi-retinal membranes, retinal vein occlusion, or any pre-existing macular disease
  • Only one eye of each patient can be enrolled

Treatment and study plan

2. Xibrom (Bromfenac)

Drug

Group 1 and 2: 1 drop(Instill one drop in the eye that was operated on twice daily)3 days prior to surgery and 4 doses during dilation immediately before the procedure. Use for 4 weeks after surgery.

1. Pred Forte

Drug

Group 1 Instill one drop in the eye that was operated on four times a day starting on day of surgery and use for four weeks.

Group 2 Instill one drop in the eye that was operated on twice a day starting on day of surgery and use for four weeks.

Primary outcomes

  1. Cystoid Macular Edema

    Time frame: 11 months

Secondary outcomes

  1. Retinal Thickening

    Time frame: 11 months

Sponsors and collaborators

Lead sponsor

Center For Excellence In Eye Care

Other

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 7, 2007
Registry last updated
Sep 25, 2008

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.

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