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Study of PGA Suture in Ophthalmology

Evaluating the Safety and Efficacy of Polyglycolic Acid Suture in Ophthalmic Surgical Procedures

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00351429
Enrollment
50
Registered
2006-07-12
Start date
2005-10-31
Completion date
2006-05-31
Last updated
2009-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

Keywords

Glaucoma, Trabeculectomy, Sutures

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.

Interventions

DEVICEPolyglycolic acid suture

PGA suture used in Trabeculectomy surgery

Sponsors

Aurolab
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Life threatening illness * Immunosuppressive disorders * Chronic infection

Design outcomes

Primary

MeasureTime frame
Suture characteristics1 month, 3 months

Secondary

MeasureTime frame
Conjunctival status1 month, 3 months
Bleb characteristics1 month, 3 months

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026