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OpenTrials
Completed

NCT Number: NCT00348244

Ketorolac vs. Steroid in the Prevention of CME

Evaluate if the incidence of sub clinical CME can be significantly reduced by use of peri-operative Acular LS plus Pred Forte when compared with Pred Forte alone in normal cataract patients.

Completed

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dr. Wittpenn

Stony Brook, New York, 11790, United States

Who can participate

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 with surgeon expectation of 20/20 BCVA postoperatively
  • 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)
  • 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 if obtainable
  • Diabetic patients with a history of macular edema or diabetic retinopathy
  • AMD patients with less than a 20/20 surgical outcome expectation, epi-retinal membranes, retinal vein occlusion, or any pre-existing macular disease

Treatment and study plan

Ketorolac, Prednisolone Acetate

Drug

Sponsors and collaborators

Lead sponsor

Innovative Medical

Industry

Registry information

Official study title

A Masked Comparison of Acular LS Plus Steroid Versus Steroid Alone for the Prevention of Macular Leakage in Cataract Patients

Important dates

First posted
Jul 4, 2006
Registry last updated
Jan 17, 2007

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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