Ketorolac vs. Steroid in the Prevention of CME

Phase 4

Completed

• Conditions: Cataract

• Registration Number: NCT00348244
• Lead Sponsor: Innovative Medical

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-06-30
• Study First Submitted QC: 2006-06-30
• Study First Posted: 2006-07-04
• Status Verified: 2007-01
• Last Update Submitted: 2007-01-15
• Last Update Posted: 2007-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

Dr. Wittpenn; 🇺🇸 Stony Brook, New York, United States