Transconjunctival Needling Revision Versus Medical Treatment
Primary Purpose
Primary Open Angle Glaucoma
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Transconjunctival needling revision
Medical treatment
Sponsored by
About this trial
This is an interventional treatment trial for Primary Open Angle Glaucoma focused on measuring Encapsulated blebs, trabeculectomy failure, glaucoma
Eligibility 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
Sites / Locations
- University of Sao Paulo General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Transconjunctival needling revision
Medical treatment
Arm Description
Eyes with primary glaucoma surgery failure with encapsulated bleb submitted to surgical revision
Eyes with primary glaucoma surgery failure with encapsulated blebs were treated with medical treatment (hypotensive eye drops)
Outcomes
Primary Outcome Measures
Intraocular pressure
Secondary Outcome Measures
Full Information
NCT ID
NCT01887223
First Posted
June 24, 2013
Last Updated
June 26, 2013
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01887223
Brief Title
Transconjunctival Needling Revision Versus Medical Treatment
Official Title
Early Transconjunctival Needling Revision With 5-fluorouracil Versus Medical Treatment in Encapsulated Blebs: a 12-month Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma
Keywords
Encapsulated blebs, trabeculectomy failure, glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transconjunctival needling revision
Arm Type
Experimental
Arm Description
Eyes with primary glaucoma surgery failure with encapsulated bleb submitted to surgical revision
Arm Title
Medical treatment
Arm Type
Active Comparator
Arm Description
Eyes with primary glaucoma surgery failure with encapsulated blebs were treated with medical treatment (hypotensive eye drops)
Intervention Type
Procedure
Intervention Name(s)
Transconjunctival needling revision
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Medical treatment
Other Intervention Name(s)
Timoptol 0,5%, Xalatan, Trusopt, Alphagan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intraocular pressure
Time Frame
12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Remo Susanna Jr., MD
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ricardo Suzuki, MD
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo General Hospital
City
Sao Paulo
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
9261306
Citation
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.
Results Reference
result
PubMed Identifier
24212847
Citation
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.
Results Reference
derived
Learn more about this trial
Transconjunctival Needling Revision Versus Medical Treatment
We'll reach out to this number within 24 hrs