Study of PGA Suture in Ophthalmology

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00351429
• Other study ID #: 1PN1010510
• Status: Completed
• Phase: Phase 4
• First received: July 11, 2006
• Last updated: February 10, 2009
• Start date: October 2005
• Est. completion date: May 2006

Study information

• Verified date: February 2009
• Source: Aurolab
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• Polyglycolic acid suture
PGA suture used in Trabeculectomy surgery

Locations

Country	Name	City	State
India	Aravind Eye Hospital	Madurai	Tamil Nadu

Sponsors (1)

Lead Sponsor	Collaborator
Aurolab

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suture characteristics		1 month, 3 months	No
Secondary	Bleb characteristics		1 month, 3 months	Yes
Secondary	Conjunctival status		1 month, 3 months	Yes