Trial | NCT03751059  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    150
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 Started
Nov 30
2020
Anticipated
Primary Completion
Sep 30
2021
Anticipated
Study Completion
Dec 31
2021
Anticipated
Last Update
Oct 19
2020

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.

  • Other names: Bromfenac

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.

NSAID Active Comparator

Bromfenac 0.07% Oph Susp: used from one week post-op to three months post-op

Steroid Active Comparator

Dexamethasone: used from one week post-op to three months post-op

Criteria 

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
No Results Posted