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Study of PGA Suture in Ophthalmology

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ClinicalTrials.gov Identifier: NCT00351429
Recruitment Status : Completed
First Posted : July 12, 2006
Last Update Posted : February 11, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
To evaluate the safety and efficacy of polyglycolic acid suture in ophthalmic surgical procedures

Condition or disease Intervention/treatment Phase
Glaucoma Device: Polyglycolic acid suture Phase 4

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
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
Study Start Date : October 2005
Primary Completion Date : May 2006
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Glaucoma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Device: Polyglycolic acid suture
PGA suture used in Trabeculectomy surgery
Other Name: Aurocryl


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: A. Heber, Aurolab
ClinicalTrials.gov Identifier: NCT00351429     History of Changes
Other Study ID Numbers: 1PN1010510
First Posted: July 12, 2006    Key Record Dates
Last Update Posted: February 11, 2009
Last Verified: February 2009

Keywords provided by Aurolab:
Glaucoma
Trabeculectomy
Sutures

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases