Transconjunctival Needling Revision Versus Medical Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01887223
Recruitment Status : Completed
First Posted : June 26, 2013
Last Update Posted : June 27, 2013
Information provided by (Responsible Party):
Ricardo Suzuki, 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.

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

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Intraocular pressure [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01887223

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

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ricardo Suzuki, Assistant professor of Ophthalmology at HCFMUSP, University of Sao Paulo General Hospital Identifier: NCT01887223     History of Changes
Other Study ID Numbers: TNRVMT-RS
First Posted: June 26, 2013    Key Record Dates
Last Update Posted: June 27, 2013
Last Verified: June 2013

Keywords provided by Ricardo Suzuki, University of Sao Paulo General Hospital:
Encapsulated blebs
trabeculectomy failure

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