Effect of Topical Brimonidine on Post Cataract Surgery Corneal Edema

NCT00800423 | Unknown Phase 3

• 1 other identifier: 5189
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Corneal Edema; Visual Acuity

Keywords

corneal edema; postoperative corneal edema; central corneal thickness; visual acuity; postoperative; brimonidine; timolol; cataract surgery

Outcome Measures

Primary Outcomes (1)

• central corneal thickness in micrometer

  day 0 (day of enrollment ), day 7, day 30

Secondary Outcomes (1)

• grading of corneal edema (1-3)

  day 0 (day of enrollment), day 7, day 30

Study Arms (3)

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

Brimonidine Tartrate 0.2% DRUG

Brimonidine Tartrate 0.2% drops 1 drop twice a day for 1 month in the operated eye

Also known as: ALPHAGAN P

brimonidine

Timolol maleate 0.5% DRUG

timolol maleate 0.5% drops 1 drop twice a day for 1 month in the operated eye

Also known as: TILOPTIC, V-OPTIC

2 tmolol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• day after uneventful cataract surgery
• corneal edema (grade 2 to 3)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Rabin medical center ophthalmology deparment

Petah Tikva, 49100, Israel

Location

MeSH Terms

Conditions

Corneal Edema

Interventions

Brimonidine Tartrate

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Anat Robinson, MD

  Rabin medical center, Clalit health services , Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anat Robinson, MD

CONTACT

9729377176; robina@clalit.org.il

Omer Y Bialer, MD

CONTACT

9729377171; omerb@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 30, 2008
• First Posted: December 2, 2008
• Study Start: January 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: December 2, 2008

Record last verified: 2008-11

Locations

IL (1)