Effect of Topical Brimonidine on Post Cataract Surgery Co... | NCT00800423

Studies
Effect of Topical Brimonidine on Post Cataract Surgery Corneal Edema

NCT00800423

Sponsor

Rabin Medical Center

Status

Unknown status

Last Update Posted

Dec 2, 2008Estimated

Enrollment

150Estimated

Phase

Phase 3

Conditions

Corneal Edema
Visual Acuity

Interventions

Brimonidine Tartrate 0.2%
Timolol maleate 0.5%

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Jan 2010Estimated

Completion Date

Jan 2010Estimated

First Submitted Date

Nov 30, 2008

First Submission Date that Met QC Criteria

Dec 1, 2008

First Posted Date

Dec 2, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2008

Last Update Posted Date

Dec 2, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
brimonidine	Experimental	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%
2 tmolol	Active Comparator	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%
3	No Intervention	50 patients will not receive any additional drug to the usual medications after cataract surgery (corticosteroids and antibiotics drops)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brimonidine Tartrate 0.2%	Drug	Brimonidine Tartrate 0.2% drops 1 drop twice a day for 1 month in the operated eye	brimonidine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
central corneal thickness in micrometer		day 0 (day of enrollment ), day 7, day 30

Secondary Outcomes

Measure	Description	Time Frame
grading of corneal edema (1-3)		day 0 (day of enrollment), day 7, day 30

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anat Robinson, MD	Contact	9729377176		robina@clalit.org.il
Omer Y Bialer, MD	Contact	9729377171		omerb@clalit.org.il

Overall Officials

Name	Affiliation	Role
Anat Robinson, MD	Rabin medical center, Clalit health services , Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rabin medical center ophthalmology deparment		Petah Tikva		49100	Israel

Condition Browse Module

MeSH Terms

ID	Term
D015715	Corneal Edema

Ancestor Terms

ID	Term
D003316	Corneal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068438	Brimonidine Tartrate

Ancestor Terms

ID	Term
D011810	Quinoxalines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided