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| Sponsor: | Rabin Medical Center |
|---|---|
| Information provided by: | Rabin Medical Center |
| ClinicalTrials.gov Identifier: | NCT00800423 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Corneal Edema Visual Acuity |
Drug: Brimonidine Tartrate 0.2% Drug: Timolol maleate 0.5% |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 3 Study of Brimonidine Tartrate Drops Efficacy in Reducing Post Operative Corneal Edema After Cataract Surgery |
| Estimated Enrollment: | 150 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | January 2010 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: brimonidine
50 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) |
Drug: Brimonidine Tartrate 0.2%
Brimonidine Tartrate 0.2% drops 1 drop twice a day for 1 month in the operated eye Other Name: ALPHAGAN P
|
|
Active Comparator: 2 tmolol
50 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) |
Drug: Timolol maleate 0.5%
timolol maleate 0.5% drops 1 drop twice a day for 1 month in the operated eye Other Names:
|
|
No Intervention: 3
50 patients will not receive any additional drug to the usual medications after cataract surgery (corticosteroids and antibiotics drops)
|
Most patients undergoing cataract surgery suffer from corneal edema after the surgery which temporarily reduces their visual acuity until corneal edema resolves over several weeks Brimonidine drops are a well known and safe Anti-glaucoma medication, used to lower intra ocular pressure.
there have been several clinical observations that patients receiving Brimonidine drops had a faster resolution of their corneal edema even in the presence of normal intra-ocular pressure.
The investigators postulated that administering topical Brimonidine to patients with significant post operative corneal edema will hasten their recovery and visual improvement.
In order to prove that Brimonidine drops contribute to faster resolution of cornel edema and visual improvement, the study will randomly compare 50 post cataract surgery patients (group A)who will be administered Brimonidine to 2 control groups (50 people in each group):
group B will be given topical timolol drops 0.5% (another well recognized anti glaucoma medication which reduces intra-ocular pressure by different mechanism than Brimonidine.
Group C will not be given any test drug. All 3 groups will receive the regular post operative medications which include corticosteroids and antibiotics.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Anat Robinson, MD | 9729377176 | robina@clalit.org.il |
| Contact: Omer Y Bialer, MD | 9729377171 | omerb@clalit.org.il |
| Israel | |
| Rabin medical center ophthalmology deparment | Not yet recruiting |
| Petah-Tikva, Israel, 49100 | |
| Contact: Weinberger Dov, MD 9729376101 dwin@clalit.org.il | |
| Contact: Omer bialer, MD 9729377171 omerb@clalit.org.il | |
| Sub-Investigator: omer y bialer, MD | |
| Principal Investigator: Anat Robinson, MD | |
| Principal Investigator: | Anat Robinson, MD | Rabin medical center, Clalit health services , Israel |
More Information
| Responsible Party: | Dr. Robinson Anat, Rabin Medical Center |
| ClinicalTrials.gov Identifier: | NCT00800423 History of Changes |
| Other Study ID Numbers: | 5189 |
| Study First Received: | November 30, 2008 |
| Last Updated: | December 1, 2008 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
|
corneal edema postoperative corneal edema central corneal thickness visual acuity |
postoperative brimonidine timolol cataract surgery |
|
Corneal Edema Edema Cataract Corneal Diseases Eye Diseases Signs and Symptoms Lens Diseases Timolol Brimonidine Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Antihypertensive Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists |
