Study of PGA Suture in Ophthalmology - Full Text View

Sponsored by:	Aurolab
Information provided by:	Aurolab
ClinicalTrials.gov Identifier:	NCT00351429

Purpose

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

Condition	Intervention	Phase
Glaucoma	Device: Polyglycolic acid suture	Phase IV

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Polyglycolic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Evaluating the Safety and Efficacy of Polyglycolic Acid Suture in Ophthalmic Surgical Procedures

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
1: Experimental	Device: Polyglycolic acid suture PGA suture used in Trabeculectomy surgery

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00351429

Locations

India, Tamil Nadu
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:	Aurolab ( A. Heber )
Study ID Numbers:	1PN1010510
Study First Received:	July 11, 2006
Last Updated:	May 23, 2008
ClinicalTrials.gov Identifier:	NCT00351429
Health Authority:	India: Ministry of Health

Keywords provided by Aurolab:

Glaucoma
Trabeculectomy
Sutures

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Hypertension
Ocular Hypertension

ClinicalTrials.gov processed this record on January 14, 2009