Ketorolac vs. Steroid in the Prevention of CME

Sponsor

Innovative Medical (Industry)

Overall Status

Completed

CT.gov ID

NCT00348244

Collaborator

(none)

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Drug: Ketorolac, Prednisolone Acetate	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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