NCT03751059

NSAID vs Steroid in Trabeculectomy Wound Management

An Investigator-Initiated Multicenter Prospective Clinical Trial to Examine the Efficacy of Peri-operative NSAID vs Steroid Treatment in Trabeculectomy Wound Management

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Cindy Hutnik · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glaucoma

Interventions

Type	Name	Description
DRUG	Bromfenac 0.07% Oph Susp	Bromfenac 0.07% Oph Susp to be used post-operatively (week 1 to month 3) by one treatment group.
DRUG	Dexamethasone	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.

Timeline

• Start date: 2020-11-01
• Primary completion: 2021-09-01
• Completion: 2021-12-01
• First posted: 2018-11-23
• Last updated: 2020-10-19