NSAID vs Steroid in Trabeculectomy Wound Management

Cindy Hutnik

Status and phase: Unknown; Phase 4

Conditions: Glaucoma

Treatments: Drug: Dexamethasone; Drug: Bromfenac 0.07% Oph Susp

Study type: Interventional

Funder types: Other

Identifiers

NCT03751059

TWM

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

NSAID

Active Comparator group

Description:

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

Treatment:

Drug: Bromfenac 0.07% Oph Susp

Steroid

Active Comparator group

Description:

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

Treatment:

Drug: Dexamethasone