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Study of PGA Suture in Ophthalmology

Phase 4
Completed
Conditions
Glaucoma
Interventions
Device: Polyglycolic acid suture
Registration Number
NCT00351429
Lead Sponsor
Aurolab
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
50
Inclusion Criteria
  • Patients undergoing Trabeculectomy with IOL implantation
  • Current residence within 60 kms of madurai
Exclusion Criteria
  • Life threatening illness
  • Immunosuppressive disorders
  • Chronic infection

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
1Polyglycolic acid suture-
Primary Outcome Measures
NameTimeMethod
Suture characteristics1 month, 3 months
Secondary Outcome Measures
NameTimeMethod
Conjunctival status1 month, 3 months
Bleb characteristics1 month, 3 months

Trial Locations

Locations (1)

Aravind Eye Hospital

🇮🇳

Madurai, Tamil Nadu, India

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