NCT00351429

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2005

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2006

Completed
Last Updated

February 11, 2009

Status Verified

February 1, 2009

Enrollment Period

7 months

First QC Date

July 11, 2006

Last Update Submit

February 10, 2009

Conditions

Glaucoma

Keywords

GlaucomaTrabeculectomySutures

Outcome Measures

Primary Outcomes (1)

  • Suture characteristics

    1 month, 3 months

Secondary Outcomes (2)

  • Bleb characteristics

    1 month, 3 months

  • Conjunctival status

    1 month, 3 months

Study Arms (1)

1

EXPERIMENTAL
Device: Polyglycolic acid suture

Interventions

Polyglycolic acid sutureDEVICE

PGA suture used in Trabeculectomy surgery

Also known as: Aurocryl
1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Life threatening illness
  • Immunosuppressive disorders
  • Chronic infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aravind Eye Hospital

Madurai, Tamil Nadu, 625 020, India

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Ramaswamy Krishnadas, DO, Dip NB

    Aravind Eye Hospital, Madurai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 11, 2006

First Posted

July 12, 2006

Study Start

October 1, 2005

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

February 11, 2009

Record last verified: 2009-02

Locations

IN(1)