Back to resultsStudy of PGA Suture in Ophthalmology
Primary Purpose
Glaucoma
Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Polyglycolic acid suture
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, Trabeculectomy, Sutures
Eligibility Criteria
Inclusion Criteria: Patients undergoing Trabeculectomy with IOL implantation Current residence within 60 kms of madurai Exclusion Criteria: Life threatening illness Immunosuppressive disorders Chronic infection
Sites / Locations
- Aravind Eye Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Suture characteristics
Secondary Outcome Measures
Bleb characteristics
Conjunctival status
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00351429
Brief Title
Study of PGA Suture in Ophthalmology
Official Title
Evaluating the Safety and Efficacy of Polyglycolic Acid Suture in Ophthalmic Surgical Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Aurolab
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the safety and efficacy of polyglycolic acid suture in ophthalmic surgical procedures
Detailed Description
The sutures are classified into non-absorbable and absorbable sutures. Violet braided polyglycolic acid suture is the synthetic absorbable suture used in wound closure in ophthalmology, cardiology, neurology and plastic & reconstructive surgeries. In ophthalmology, PGA sutures are used in Trabeculectomy (Glaucoma), Orbit and Oculoplasty, Lid and Socket Reconstruction, Squint, ptosis and retinal detachment surgeries.
Glaucoma patients who met the inclusion criteria were recruited for this study. Uniform surgery and suturing technique was performed in all patients (Trabeculectomy with IOL implantation). Surgeon assessed suture characteristics during surgery and wound integrity at the end of surgery.
Patients were followed up during 1 day, 1 month and 3 months post operatively. Visual acuity, Intraocular Pressure (IOP), suture characteristics, wound integrity, inflammation and conjunctival status were examined during each follow up visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Glaucoma, Trabeculectomy, Sutures
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Polyglycolic acid suture
Other Intervention Name(s)
Aurocryl
Intervention Description
PGA suture used in Trabeculectomy surgery
Primary Outcome Measure Information:
Title
Suture characteristics
Time Frame
1 month, 3 months
Secondary Outcome Measure Information:
Title
Bleb characteristics
Time Frame
1 month, 3 months
Title
Conjunctival status
Time Frame
1 month, 3 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing Trabeculectomy with IOL implantation
Current residence within 60 kms of madurai
Exclusion Criteria:
Life threatening illness
Immunosuppressive disorders
Chronic infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramaswamy Krishnadas, DO, Dip NB
Organizational Affiliation
Aravind Eye Hospital, Madurai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aravind Eye Hospital
City
Madurai
State/Province
Tamil Nadu
ZIP/Postal Code
625 020
Country
India
12. IPD Sharing Statement
Learn more about this trial
Study of PGA Suture in Ophthalmology
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