Study of PGA Suture in Ophthalmology

Aurolab

Status and phase: Completed; Phase 4

Conditions: Glaucoma

Treatments: Device: Polyglycolic acid suture

Study type: Interventional

Funder types: Other

Identifiers

NCT00351429

1PN1010510

Details and patient eligibility

About

To evaluate the safety and efficacy of polyglycolic acid suture in ophthalmic surgical procedures

Full 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.

Enrollment: 50 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing Trabeculectomy with IOL implantation
• Current residence within 60 kms of madurai

Exclusion criteria

• Life threatening illness
• Immunosuppressive disorders
• Chronic infection

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

1

Experimental group

Treatment:

Device: Polyglycolic acid suture