Glaucoma
Conditions
Brief summary
This study will examine the efficacy of steroid vs NSAID treatment in relation to trabeculectomy wound management. Eligible study participants will be randomized to receive either steroid or NSAID topical treatment one week post-trabeculectomy. Each group will dose with their assigned study treatment until three months post-trabeculectomy. Study participants will be followed for twelve months post-trabeculectomy.
Interventions
DRUGBromfenac 0.07% Oph Susp
Bromfenac 0.07% Oph Susp to be used post-operatively (week 1 to month 3) by one treatment group.
DRUGDexamethasone
Topical dexamethasone to be used by all study participants for one week pre-trabeculectomy and by all study participants for one week post-trabeculectomy. At one week post-op, one of the treatment groups will continue to dose with dexamethasone.
Sponsors
Glaucoma Research Society of Canada
Cindy Hutnik
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
* Adult patients over the age of 18 years * Uncontrolled open angle glaucoma * Scheduled to undergo stand-alone trabeculectomy * No previous incisional glaucoma surgery * No ocular surgery of any kind in prior 6 months
Exclusion criteria
* steroids and/or NSAIDs contraindicated * poor corneal epithelial health
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target IOP | 12 months | the proportion of patients achieving a target IOP range (≤21, ≤18, ≤15 or ≤12 mmHg) at 12 months post-operatively |
Contacts
Primary ContactStudy Coordinator
Outcome results
None listed