An Investigator-Initiated Multicenter Prospective Clinical Trial to Examine the Efficacy of Peri-operative NSAID vs Steroid Treatment in Trabeculectomy Wound Management
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 150
- Primary Endpoint
- Target IOP
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
NSAID
Bromfenac 0.07% Oph Susp: used from one week post-op to three months post-op
Intervention: Bromfenac 0.07% Oph Susp (Drug)
Steroid
Dexamethasone: used from one week post-op to three months post-op
Intervention: Dexamethasone (Drug)
Outcomes
Primary Outcomes
Target IOP
Time Frame: 12 months
the proportion of patients achieving a target IOP range (≤21, ≤18, ≤15 or ≤12 mmHg) at 12 months post-operatively
Secondary Outcomes
No secondary outcomes reported
Investigators
Cindy Hutnik
Principal Investigator
Ivey Eye Institute