Transconjunctival Needling Revision Versus Medical Treatment

Phase 2

Completed

• Conditions: Primary Open Angle Glaucoma
• Interventions: Procedure: Transconjunctival needling revision; Drug: Medical treatment

• Registration Number: NCT01887223
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

When the glaucoma filtering surgery failures (intraocular pressure rises again), the options is start to use the hypotensive eye drops again (medical treatment). However, in some cases (encapsulated blebs), there is a simple surgical revision that can revival the primary failure surgery. It calls transconjunctival needling revision. In this study, the investigators compare the efficacy of this revision versus medical treatment in 12-month follow up in eyes with encapsulated blebs.

Detailed Description

To compare the efficacy of transconjunctival needling revision (TNR) with 5-fluorouracil versus medical treatment (MT) in glaucomatous eyes with uncontrolled intraocular pressure (IOP) due to encapsulated bleb after trabeculectomy Prospective, randomized, interventional study. A total of forty eyes of 39 patients with elevated IOP and encapsulated bleb diagnosed at maximum 5 months after primary trabeculectomy with mitomycin C were included. The eyes were randomized to either TNR with 5-fluorouracil or MT (hypotensive eyedrops). A maximum of two TNR per patient was allowed in the needling arm. All eyes were followed up for 12 months. Success of treatment was defined as IOP ≤ 18mmHg and 20% reduction from baseline at last follow up.

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2013-06
• Study First Submitted: 2013-06-24
• Study First Submitted QC: 2013-06-24
• Study First Posted: 2013-06-26
• Last Update Submitted: 2013-06-26
• Last Update Posted: 2013-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Eyes with encapsulated blebs developed in 5 months or less following primary glaucoma filtering surgery (trabeculectomy) and intraocular pressure >= 20mmHg

Exclusion Criteria

• Previous other ocular surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transconjunctival needling revision	Transconjunctival needling revision	Eyes with primary glaucoma surgery failure with encapsulated bleb submitted to surgical revision
Medical treatment	Medical treatment	Eyes with primary glaucoma surgery failure with encapsulated blebs were treated with medical treatment (hypotensive eye drops)

Primary Outcome Measures

Name	Time	Method
Intraocular pressure	12 months

Trial Locations

Locations (1)

University of Sao Paulo General Hospital; 🇧🇷 Sao Paulo, Brazil