Study of PGA Suture in Ophthalmology

This study has been completed.
Sponsor:
Information provided by:
Aurolab
ClinicalTrials.gov Identifier:
NCT00351429
First received: July 11, 2006
Last updated: February 10, 2009
Last verified: February 2009
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bleb characteristics [ Time Frame: 1 month, 3 months ] [ Designated as safety issue: Yes ]
  • Conjunctival status [ Time Frame: 1 month, 3 months ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00351429

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

No publications provided

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

Keywords provided by Aurolab:
Glaucoma
Trabeculectomy
Sutures

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on October 02, 2014