Transconjunctival Needling Revision Versus Medical Treatment

NCT01887223 — Phase 2, Completed, 40 participants, University of Sao Paulo General Hospital

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT01887223
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	40 (Actual)
Sponsor	University of Sao Paulo General Hospital (Other)
Conditions	Primary Open Angle Glaucoma
Interventions	Transconjunctival needling revision, Medical treatment (Procedure, drug)
Dates	start 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 in Brazil

-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.

Expand all sections · Collapse all

+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.

+Arms and interventions

Arm	Type	Interventions	Description
Transconjunctival needling revision	Experimental	Procedure: Transconjunctival needling revision	Eyes with primary glaucoma surgery failure with encapsulated bleb submitted to surgical revision
Medical treatment	Active comparator	Drug: Medical treatment	Eyes with primary glaucoma surgery failure with encapsulated blebs were treated with medical treatment (hypotensive eye drops)

Transconjunctival needling revision (Procedure): 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.
Medical treatment (Drug), also known as Timoptol 0,5%, Xalatan, Trusopt, Alphagan: 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.

+Outcome measures

Primary outcomes

Intraocular pressure [12 months]

+Eligibility

Sex: All

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

+Locations (1)

Facility	City	Country	Status
University of Sao Paulo General Hospital	São Paulo, São Paulo	Brazil

+Publications

Results publication: 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. doi: 10.1016/s0161-6420(97)30155-9. PMID 9261306
Results publication: Suzuki R, Susanna R Jr. Early transconjunctival needling revision with 5-fluorouracil versus medical treatment in encapsulated blebs: a 12-month prospective study. Clinics (Sao Paulo). 2013 Oct;68(10):1376-9. doi: 10.6061/clinics/2013(10)14. PMID 24212847

+Investigators

Remo Susanna Jr., MD, Study chair, University of Sao Paulo General Hospital
Ricardo Suzuki, MD, Principal investigator, University of Sao Paulo General Hospital