Study of PGA Suture in Ophthalmology
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluating the Safety and Efficacy of Polyglycolic Acid Suture in Ophthalmic Surgical Procedures|
- Suture characteristics [ Time Frame: 1 month, 3 months ] [ Designated as safety issue: No ]
- Bleb characteristics [ Time Frame: 1 month, 3 months ] [ Designated as safety issue: Yes ]
- Conjunctival status [ Time Frame: 1 month, 3 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2005|
|Study Completion Date:||May 2006|
|Primary Completion Date:||May 2006 (Final data collection date for primary outcome measure)|
Device: Polyglycolic acid suture
PGA suture used in Trabeculectomy surgery
Other Name: Aurocryl
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00351429
|Aravind Eye Hospital|
|Madurai, Tamil Nadu, India, 625 020|
|Principal Investigator:||Ramaswamy Krishnadas, DO, Dip NB||Aravind Eye Hospital, Madurai|