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
1 other identifier
interventional
150
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2020
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2018
CompletedFirst Posted
Study publicly available on registry
November 23, 2018
CompletedStudy Start
First participant enrolled
November 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedOctober 19, 2020
October 1, 2020
10 months
November 16, 2018
October 15, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Target IOP
the proportion of patients achieving a target IOP range (≤21, ≤18, ≤15 or ≤12 mmHg) at 12 months post-operatively
12 months
Study Arms (2)
NSAID
ACTIVE COMPARATORBromfenac 0.07% Oph Susp: used from one week post-op to three months post-op
Steroid
ACTIVE COMPARATORDexamethasone: used from one week post-op to three months post-op
Interventions
Bromfenac 0.07% Oph Susp to be used post-operatively (week 1 to month 3) by one treatment group.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- steroids and/or NSAIDs contraindicated
- poor corneal epithelial health
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cindy Hutniklead
- Glaucoma Research Society of Canadacollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cindy Hutnik, MD
Ivey Eye Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 16, 2018
First Posted
November 23, 2018
Study Start
November 1, 2020
Primary Completion
September 1, 2021
Study Completion
December 1, 2021
Last Updated
October 19, 2020
Record last verified: 2020-10