Effect of Topical Brimonidine on Post Cataract Surgery Corneal Edema

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Rabin Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00800423
First received: November 30, 2008
Last updated: December 1, 2008
Last verified: November 2008
  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 3

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

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • central corneal thickness in micrometer [ Time Frame: day 0 (day of enrollment ), day 7, day 30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • grading of corneal edema (1-3) [ Time Frame: day 0 (day of enrollment), day 7, day 30 ] [ Designated as safety issue: No ]

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:
  • TILOPTIC
  • V-OPTIC
No Intervention: 3
50 patients will not receive any additional drug to the usual medications after cataract surgery (corticosteroids and antibiotics drops)

Detailed Description:

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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00800423

Contacts
Contact: Anat Robinson, MD 9729377176 robina@clalit.org.il
Contact: Omer Y Bialer, MD 9729377171 omerb@clalit.org.il

Locations
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         
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Anat Robinson, MD Rabin medical center, Clalit health services , Israel
  More Information

No publications provided

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

Keywords provided by Rabin Medical Center:
corneal edema
postoperative corneal edema
central corneal thickness
visual acuity
postoperative
brimonidine
timolol
cataract surgery

Additional relevant MeSH terms:
Cataract
Edema
Corneal Edema
Lens Diseases
Eye Diseases
Signs and Symptoms
Corneal 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

ClinicalTrials.gov processed this record on September 18, 2014