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NCT03751059 Clinical Trial

NSAID vs Steroid in Trabeculectomy Wound Management

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03751059
Other study ID # TWM
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date November 2020
Est. completion date December 2021

Study information
Verified date October 2020
Source Ivey Eye Institute
Contact Study Coordinator
Phone 519.646.6100
Email rboyd24@uwo.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 150
Est. completion date December 2021
Est. primary completion date September 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.
• 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.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Cindy Hutnik Glaucoma Research Society of Canada

Outcome
Type Measure Description Time frame Safety issue
Primary Target IOP the proportion of patients achieving a target IOP range (=21, =18, =15 or =12 mmHg) at 12 months post-operatively 12 months
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