NSAID vs Steroid in Trabeculectomy Wound Management

Phase 4

• Conditions: Glaucoma
• Interventions: Drug: Dexamethasone; Drug: Bromfenac 0.07% Oph Susp

• Registration Number: NCT03751059
• Lead Sponsor: Cindy Hutnik

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-16
• Study First Submitted QC: 2018-11-20
• Study First Posted: 2018-11-23
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-15
• Last Update Posted: 2020-10-19
• Study Start: 2020-11
• Primary Completion: 2021-09
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

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Exclusion Criteria

• steroids and/or NSAIDs contraindicated
• poor corneal epithelial health

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Steroid	Dexamethasone	Dexamethasone: used from one week post-op to three months post-op
NSAID	Bromfenac 0.07% Oph Susp	Bromfenac 0.07% Oph Susp: used from one week post-op to three months post-op

Primary Outcome Measures

Name	Time	Method
Target IOP	12 months	the proportion of patients achieving a target IOP range (≤21, ≤18, ≤15 or ≤12 mmHg) at 12 months post-operatively