Study of PGA Suture in Ophthalmology

NCT ID: NCT00351429

Last Updated: 2009-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Glaucoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Polyglycolic acid suture

Intervention Type DEVICE

PGA suture used in Trabeculectomy surgery

Interventions

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Polyglycolic acid suture

PGA suture used in Trabeculectomy surgery

Intervention Type DEVICE

Other Intervention Names

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Aurocryl

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Life threatening illness
* Immunosuppressive disorders
* Chronic infection
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aurolab

OTHER

Sponsor Role lead

Responsible Party

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Aurolab

Principal Investigators

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Ramaswamy Krishnadas, DO, Dip NB

Role: PRINCIPAL_INVESTIGATOR

Aravind Eye Hospital, Madurai

Locations

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Aravind Eye Hospital

Madurai, Tamil Nadu, India

Site Status

Countries

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India

Other Identifiers

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1PN1010510

Identifier Type: -

Identifier Source: org_study_id

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