NCT00453024

Brief Summary

When implanting an Ahmed glaucoma tube, a scleral flap is usually created to cover the tube, and the conjunctiva is stitched back in place with nylon 10-0 sutures. It is hypothesized that an equally safe or better method is using a bovine pericardial patch graft that can be secured in place over the tube with tissue glue, and using tissue glue to reposition the conjunctiva in place.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 28, 2007

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

May 14, 2008

Status Verified

May 1, 2008

First QC Date

March 27, 2007

Last Update Submit

May 12, 2008

Conditions

Advanced GlaucomaFailed Trabeculectomies

Keywords

Advanced glaucomaAhmed glaucoma implantAnterior segment optical coherence tomographyPericardial patch graftTissue glueScleral flapSutures

Outcome Measures

Primary Outcomes (2)

  • Anterior segment optical coherence tomography appearance and measurements of the overlying conjunctiva, areas above and beneath the pericardial patch graft or partial thickness scleral flap, anterior chamber depth

  • Intraocular pressure

Interventions

Pericardial graft & tissue gluePROCEDURE
scleral flap & suturesPROCEDURE

Eligibility Criteria

Age41 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • More than 40 years old
  • Able to give informed consent
  • Diagnosis of any type of glaucoma needing a Glaucoma drainage device (Ahmed tube implant) with or without lens extraction and intraocular lens implant because of uncontrolled intraocular pressures inspite of maximum tolerated medical therapy

You may not qualify if:

  • Inability to give informed consent
  • History of ocular infection or inflammation in the past two months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

RECRUITING

Related Publications (2)

  • Savini G, Zanini M, Barboni P. Filtering blebs imaging by optical coherence tomography. Clin Exp Ophthalmol. 2005 Oct;33(5):483-9. doi: 10.1111/j.1442-9071.2005.01066.x.

    PMID: 16181273BACKGROUND

  • Kahook MY, Noecker RJ. Fibrin glue-assisted glaucoma drainage device surgery. Br J Ophthalmol. 2006 Dec;90(12):1486-9. doi: 10.1136/bjo.2006.101253. Epub 2006 Aug 17.

    PMID: 16916877BACKGROUND

MeSH Terms

Interventions

Sutures

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

  • Paul Chew, FRCSEd,MMed

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cecilia Aquino, MD

CONTACT

67725317cel_aq@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 27, 2007

First Posted

March 28, 2007

Study Start

February 1, 2007

Study Completion

March 1, 2008

Last Updated

May 14, 2008

Record last verified: 2008-05

Locations

SG(1)