Ketorolac vs. Steroid in the Prevention of CME

Innovative Medical

Status and phase: Completed; Phase 4

Conditions: Cataract

Treatments: Drug: Ketorolac, Prednisolone Acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00348244

5152

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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