Ketorolac vs. Steroid in the Prevention of CME

NCT ID: NCT00348244

Last Updated: 2007-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cataract

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ketorolac, Prednisolone Acetate

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Innovative Medical

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

John Wittpenn, MD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmic Consultants of Long Island

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dr. Wittpenn

Stony Brook, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Wittpenn JR, Silverstein S, Heier J, Kenyon KR, Hunkeler JD, Earl M; Acular LS for Cystoid Macular Edema (ACME) Study Group. A randomized, masked comparison of topical ketorolac 0.4% plus steroid vs steroid alone in low-risk cataract surgery patients. Am J Ophthalmol. 2008 Oct;146(4):554-560. doi: 10.1016/j.ajo.2008.04.036. Epub 2008 Jul 2.

Reference Type DERIVED
PMID: 18599019 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5152

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Topical 0.4% Ketorolac and Vitreoretinal Surgery
NCT00576329 COMPLETED PHASE2/PHASE3
Oral Sedation in Vitreoretinal Surgery
NCT04346095 UNKNOWN PHASE4
Therapeutic Variables in Cataract Surgery
NCT00407017 COMPLETED PHASE4