NCT01887223

Transconjunctival Needling Revision Versus Medical Treatment

Early Transconjunctival Needling Revision With 5-fluorouracil Versus Medical Treatment in Encapsulated Blebs: a 12-month Prospective Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Open Angle Glaucoma

Interventions

Type	Name	Description
PROCEDURE	Transconjunctival needling revision	Surgical revision. A 25 Gauge needle was inserted under the subconjunctival space and perforate the encapsulated bled. The encapsulated bleb was ruptured with sweeping movement up and down, back and forth.
DRUG	Medical treatment	Hypotensive eye drops are initialized one by one regarding intraocular pressure control. Nonspecific beta blocker and/or prostaglandin, followed by carbonic anhydrase inhibitors and/or selective alpha agonist.

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2013-06-26
• Last updated: 2013-06-27

Locations

1 site across 1 country: Brazil