Overview

Ketorolac vs. Steroid in the Prevention of CME

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Details
Lead Sponsor:
Innovative Medical
Treatments:
Ketorolac
Ketorolac Tromethamine
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Criteria
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