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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%

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

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

NCT ID

NCT00800423

First Posted

November 30, 2008

Last Updated

December 1, 2008

Sponsor

Rabin Medical Center

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

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

Arm Title

2 tmolol

Arm Type

Active Comparator

Arm Description

Arm Title

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

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

robina@clalit.org.il

First Name & Middle Initial & Last Name or Official Title & Degree

Omer Y Bialer, MD

Phone

9729377171

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

dwin@clalit.org.il

First Name & Middle Initial & Last Name & Degree

Omer bialer, MD

Phone

9729377171

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

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Effect of Topical Brimonidine on Post Cataract Surgery Corneal Edema

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