Ketorolac vs. Steroid in the Prevention of CME - Full Text View

Sponsor:	Innovative Medical
Information provided by:	Innovative Medical
ClinicalTrials.gov Identifier:	NCT00348244

Purpose

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	Intervention	Phase
Cataract	Drug: Ketorolac, Prednisolone Acetate	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind
Official Title:	A Masked Comparison of Acular LS Plus Steroid Versus Steroid Alone for the Prevention of Macular Leakage in Cataract Patients

Resource links provided by NLM:

MedlinePlus related topics: Cataract

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Ketorolac Ketorolac tromethamine Medrol veriderm Methylprednisolone Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone

U.S. FDA Resources

Further study details as provided by Innovative Medical:

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00348244

Locations

United States, New York
Dr. Wittpenn
Stony Brook, New York, United States, 11790

Sponsors and Collaborators

Innovative Medical

Investigators

Principal Investigator:

John Wittpenn, MD

Ophthalmic Consultants of Long Island

More Information

No publications provided by Innovative Medical

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2008 Jul 2.

ClinicalTrials.gov Identifier:	NCT00348244 History of Changes
Other Study ID Numbers:	5152
Study First Received:	June 30, 2006
Last Updated:	January 15, 2007
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Cataract
Lens Diseases
Eye Diseases
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Ketorolac
Ketorolac Tromethamine
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids

Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics

ClinicalTrials.gov processed this record on February 09, 2012