Transconjunctival Needling Revision Versus Medical Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ricardo Suzuki, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01887223
First received: June 24, 2013
Last updated: June 26, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Primary Open Angle Glaucoma
Procedure: Transconjunctival needling revision
Drug: Medical treatment
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Transconjunctival Needling Revision With 5-fluorouracil Versus Medical Treatment in Encapsulated Blebs: a 12-month Prospective Study

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Intraocular pressure [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: May 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transconjunctival needling revision
Eyes with primary glaucoma surgery failure with encapsulated bleb submitted to surgical revision
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.
Active Comparator: Medical treatment
Eyes with primary glaucoma surgery failure with encapsulated blebs were treated with medical treatment (hypotensive eye drops)
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.
Other Names:
  • Timoptol 0,5%
  • Xalatan
  • Trusopt
  • Alphagan

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01887223

Locations
Brazil
University of Sao Paulo General Hospital
Sao Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Study Chair: Remo Susanna Jr., MD University of Sao Paulo General Hospital
Principal Investigator: Ricardo Suzuki, MD University of Sao Paulo General Hospital
  More Information

Publications:
Responsible Party: Ricardo Suzuki, Assistant professor of Ophthalmology at HCFMUSP, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01887223     History of Changes
Other Study ID Numbers: TNRVMT-RS
Study First Received: June 24, 2013
Last Updated: June 26, 2013
Health Authority: Brazil: CAPPesq from University of Sao Paulo General Hospital

Keywords provided by University of Sao Paulo General Hospital:
Encapsulated blebs
trabeculectomy failure
glaucoma

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on July 22, 2014