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Effect of Topical Brimonidine on Post Cataract Surgery Corneal Edema

Primary Purpose

Corneal Edema, Visual Acuity

Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Brimonidine Tartrate 0.2%
Timolol maleate 0.5%
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corneal Edema focused on measuring corneal edema, postoperative corneal edema, central corneal thickness, visual acuity, postoperative, brimonidine, timolol, cataract surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rabin medical center ophthalmology deparment

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

brimonidine

2 tmolol

3

Arm Description

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)

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)

50 patients will not receive any additional drug to the usual medications after cataract surgery (corticosteroids and antibiotics drops)

Outcomes

Primary Outcome Measures

central corneal thickness in micrometer

Secondary Outcome Measures

grading of corneal edema (1-3)

Full Information

First Posted
November 30, 2008
Last Updated
December 1, 2008
Sponsor
Rabin Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00800423
Brief Title
Effect of Topical Brimonidine on Post Cataract Surgery Corneal Edema
Official Title
Phase 3 Study of Brimonidine Tartrate Drops Efficacy in Reducing Post Operative Corneal Edema After Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
January 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Rabin Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Edema, Visual Acuity
Keywords
corneal edema, postoperative corneal edema, central corneal thickness, visual acuity, postoperative, brimonidine, timolol, cataract surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
brimonidine
Arm Type
Experimental
Arm Description
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)
Arm Title
2 tmolol
Arm Type
Active Comparator
Arm Description
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)
Arm Title
3
Arm Type
No Intervention
Arm Description
50 patients will not receive any additional drug to the usual medications after cataract surgery (corticosteroids and antibiotics drops)
Intervention Type
Drug
Intervention Name(s)
Brimonidine Tartrate 0.2%
Other Intervention Name(s)
ALPHAGAN P
Intervention Description
Brimonidine Tartrate 0.2% drops 1 drop twice a day for 1 month in the operated eye
Intervention Type
Drug
Intervention Name(s)
Timolol maleate 0.5%
Other Intervention Name(s)
TILOPTIC, V-OPTIC
Intervention Description
timolol maleate 0.5% drops 1 drop twice a day for 1 month in the operated eye
Primary Outcome Measure Information:
Title
central corneal thickness in micrometer
Time Frame
day 0 (day of enrollment ), day 7, day 30
Secondary Outcome Measure Information:
Title
grading of corneal edema (1-3)
Time Frame
day 0 (day of enrollment), day 7, day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anat Robinson, MD
Phone
9729377176
Email
robina@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Omer Y Bialer, MD
Phone
9729377171
Email
omerb@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anat Robinson, MD
Organizational Affiliation
Rabin medical center, Clalit health services , Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin medical center ophthalmology deparment
City
Petah-Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weinberger Dov, MD
Phone
9729376101
Email
dwin@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Omer bialer, MD
Phone
9729377171
Email
omerb@clalit.org.il
First Name & Middle Initial & Last Name & Degree
omer y bialer, MD
First Name & Middle Initial & Last Name & Degree
Anat Robinson, MD

12. IPD Sharing Statement

Learn more about this trial

Effect of Topical Brimonidine on Post Cataract Surgery Corneal Edema

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