Corneal Edema, Visual Acuity
Conditions
Keywords
corneal edema, postoperative corneal edema, central corneal thickness, visual acuity, postoperative, brimonidine, timolol, cataract surgery
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.
Interventions
Brimonidine Tartrate 0.2% drops 1 drop twice a day for 1 month in the operated eye
timolol maleate 0.5% drops 1 drop twice a day for 1 month in the operated eye
Sponsors
Rabin Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| central corneal thickness in micrometer | day 0 (day of enrollment ), day 7, day 30 |
Secondary
| Measure | Time frame |
|---|---|
| grading of corneal edema (1-3) | day 0 (day of enrollment), day 7, day 30 |
Countries
Israel
Contacts
Primary ContactAnat Robinson, MD
Backup ContactOmer Y Bialer, MD
Outcome results
None listed