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OpenTrials
Completed

NCT Number: NCT00351429

Study of PGA Suture in Ophthalmology

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

Completed

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aravind Eye Hospital

Madurai, Tamil Nadu, 625 020, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Life threatening illness
  • Immunosuppressive disorders
  • Chronic infection

Treatment and study plan

Polyglycolic acid suture

Device

PGA suture used in Trabeculectomy surgery

Other names: Aurocryl

Primary outcomes

  1. Suture characteristics

    Time frame: 1 month, 3 months

Secondary outcomes

  1. Bleb characteristics

    Time frame: 1 month, 3 months

  2. Conjunctival status

    Time frame: 1 month, 3 months

Sponsors and collaborators

Lead sponsor

Aurolab

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jul 12, 2006
Registry last updated
Feb 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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