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Study of PGA Suture in Ophthalmology

This study has been completed.
Information provided by:
Aurolab Identifier:
First received: July 11, 2006
Last updated: February 10, 2009
Last verified: February 2009
To evaluate the safety and efficacy of polyglycolic acid suture in ophthalmic surgical procedures

Condition Intervention Phase
Glaucoma Device: Polyglycolic acid suture Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Safety and Efficacy of Polyglycolic Acid Suture in Ophthalmic Surgical Procedures

Resource links provided by NLM:

Further study details as provided by Aurolab:

Primary Outcome Measures:
  • Suture characteristics [ Time Frame: 1 month, 3 months ]

Secondary Outcome Measures:
  • Bleb characteristics [ Time Frame: 1 month, 3 months ]
  • Conjunctival status [ Time Frame: 1 month, 3 months ]

Enrollment: 50
Study Start Date: October 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: Polyglycolic acid suture
PGA suture used in Trabeculectomy surgery
Other Name: Aurocryl

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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00351429

Aravind Eye Hospital
Madurai, Tamil Nadu, India, 625 020
Sponsors and Collaborators
Principal Investigator: Ramaswamy Krishnadas, DO, Dip NB Aravind Eye Hospital, Madurai
  More Information

Responsible Party: A. Heber, Aurolab Identifier: NCT00351429     History of Changes
Other Study ID Numbers: 1PN1010510
Study First Received: July 11, 2006
Last Updated: February 10, 2009

Keywords provided by Aurolab:

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases processed this record on September 21, 2017