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Endoscopic Goniotomy for Infantile Glaucoma

NCT00338533 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2013-01-08

No results posted yet for this study

Summary

Glaucoma surgery is performed on children less than 3 years old for infantile glaucoma which untreated can cause blindness. Glaucoma is an uncontrolled high eye pressure in these children often due to incomplete development of the part of the eye which normally allows fluid to drain out of the eye. Two procedures are possible and equal in their success of lowering the eye pressure. However, one (the goniotomy procedure) is preferred since it takes 10 minutes rather than 1 hour (for the trabeculotomy procedure) to perform under general anesthesia. This is important in young children to reduce anesthesia exposure especially if both eyes need surgery. If the glaucoma has caused the cornea or front of the eye to become too cloudy, then the view is too poor to place a lens on the cornea and use a needle to perform the shorter procedure. However, a small endoscope which has been FDA approved for use in the eye will allow direct viewing of the area which needs treatment. A needle attached to this endoscope allows the shorter goniotomy to be performed rather than proceeding to the longer trabeculotomy procedure. The outcome measure of this study is anesthesia time and reduction in intraocular pressure .

Conditions

Interventions

DEVICE

endoscopic goniotomy

The goninotomy is performed through an endoscope; allowing the physician a better view of the structure within the eye

Sponsors & Collaborators

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • karen Joos, MD, PhD · Vanderbilt University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Week
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-04-30
Primary Completion
2007-07-31
Completion
2007-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00338533 on ClinicalTrials.gov