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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01887223

Enrollment

Registered

2013-06-26

Start date

2010-05-31

Completion date

2011-06-30

Last updated

2013-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Open Angle Glaucoma

Keywords

Encapsulated blebs, trabeculectomy failure, glaucoma

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.

Interventions

PROCEDURETransconjunctival 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.

DRUGMedical 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Intraocular pressure	12 months

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026