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

June 24, 2013
June 26, 2013
May 2010
June 2011   (final data collection date for primary outcome measure)
Intraocular pressure [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01887223 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Transconjunctival Needling Revision Versus Medical Treatment
Early Transconjunctival Needling Revision With 5-fluorouracil Versus Medical Treatment in Encapsulated Blebs: a 12-month Prospective Study

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Primary Open Angle Glaucoma
  • 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.
    Other Names:
    • Timoptol 0,5%
    • Xalatan
    • Trusopt
    • Alphagan
  • Experimental: Transconjunctival needling revision
    Eyes with primary glaucoma surgery failure with encapsulated bleb submitted to surgical revision
    Intervention: Procedure: Transconjunctival needling revision
  • Active Comparator: Medical treatment
    Eyes with primary glaucoma surgery failure with encapsulated blebs were treated with medical treatment (hypotensive eye drops)
    Intervention: Drug: Medical treatment
Costa VP, Correa MM, Kara-Jose N. Needling versus medical treatment in encapsulated blebs. A randomized, prospective study. Ophthalmology. 1997 Aug;104(8):1215-20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01887223
TNRVMT-RS
No
Ricardo Suzuki, University of Sao Paulo General Hospital
University of Sao Paulo General Hospital
Not Provided
Study Chair: Remo Susanna Jr., MD University of Sao Paulo General Hospital
Principal Investigator: Ricardo Suzuki, MD University of Sao Paulo General Hospital
University of Sao Paulo General Hospital
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP