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Ketorolac vs. Steroid in the Prevention of CME

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00348244
Enrollment
Unknown
Registered
2006-07-04
Start date
Unknown
Completion date
Unknown
Last updated
2007-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

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.

Interventions

DRUGKetorolac, Prednisolone Acetate

Sponsors

Innovative Medical
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026