Corneal Edema | Effect of Topical Brimonidine on Post Cataract Surgery Corneal Edema
Corneal Edema research study
What is the primary objective of this study?
Most patients undergoing cataract surgery suffer from corneal edema after the surgery. Brimonidine drops are a well known and safe Anti-glaucoma medication. the investigators have made several clinical observations that patients receiving Brimonidine drops had a faster resolution of their corneal edema even if they had normal intra-ocular pressure. The investigators believe that administering topical Brimonidine to patients with significant post operative corneal edema will hasten the resolution of their corneal edema.
Who is eligible to participate?
Inclusion Criteria: - 1 day after uneventful cataract surgery - corneal edema (grade 2 to 3) Exclusion Criteria: - glaucoma - higher than normal intraocular pressure (>23 mm Hg) - known sensitivity or contra indication to brimonidine - known sensitivity or contra indication to timolol - pre operative corneal or anterior segment disease - intraoperative complications - major ocular pathology other than corneal that reduced vision (retinal degeneration, optic neuropathy etc.) - pregnant women - children
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Brimonidine Tartrate 0.2%Brimonidine Tartrate 0.2% drops 1 drop twice a day for 1 month in the operated eye
Drug:Timolol maleate 0.5%timolol maleate 0.5% drops 1 drop twice a day for 1 month in the operated eye
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
brimonidine50 patients receiving Brimonidine Tartrate drops in the operated eye: 1 drop X2 a day for 1 month. they will also be administered the usual medications after cataract surgery (corticosteroids and antibiotics drops)
2 tmolol50 patients receiving timolol maleate 0.5% drops in the operated eye 1 drop X2 a day for 1 month. they will also be administered the usual medications after cataract surgery (corticosteroids and antibiotics drops)
350 patients will not receive any additional drug to the usual medications after cataract surgery (corticosteroids and antibiotics drops)
Start Date: January 2009
Completed Date: January 2010
Phase: Phase 3
Primary Outcome: central corneal thickness in micrometer
Secondary Outcome: grading of corneal edema (1-3)
Study sponsors, principal investigator, and references
Principal Investigator: Anat Robinson, MD
Lead Sponsor: Rabin Medical Center