Status:

COMPLETED

Ketorolac vs. Steroid in the Prevention of CME

Lead Sponsor:

Innovative Medical

Conditions:

Cataract

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

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.

Eligibility Criteria

Inclusion

  • · 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

  • · 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

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00348244

Last Update

January 17 2007

Active Locations (1)

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1

Dr. Wittpenn

Stony Brook, New York, United States, 11790