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Endoscopic Goniotomy for Infantile Glaucoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karen Joos, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00338533
First received: June 15, 2006
Last updated: January 6, 2013
Last verified: January 2013
  Purpose

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 .


Condition Intervention
Glaucoma
Device: endoscopic goniotomy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Goniotomy for Infantile Glaucoma

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Intraocular pressure reduction [ Time Frame: Postoperatively ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clearing of corneal edema [ Time Frame: Postoperatively ] [ Designated as safety issue: Yes ]

Enrollment: 7
Study Start Date: April 1997
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: endoscopic goniotomy
    The goninotomy is performed through an endoscope; allowing the physician a better view of the structure within the eye
Detailed Description:

b. The standard examination under anesthesia initially will be performed including measuring the child's intraocular pressure, measuring dimensions of the eye, examining the front of the eye under the operating microscope, examining the portion of the eye where the fluid drains, evaluating the back of the eye with an ultrasound, and possible documentation with photographs.

When the diagnosis is confirmed by this examination, the eye or eyes will be carefully evaluated for their clarity. If a standard goniotomy procedure can not be done, then the endoscopic goniotomy will be performed. The procedure is identical with: cleaning the eyelid skin, using a speculum to open the eyelids, making a small cut into the cornea, and placing a viscoelastic substance into the eye to maintain its shape. The procedure then differs since the inserted needle is attached to the viewing endoscope. I will then view the inside of the eye on a TV monitor in addition to looking through the operating microscope. This will allow me to directly see the structures which I will need to cut. Normally, I depend upon looking through a lens placed on the cornea which must be fairly clear so that I can see to cut the structures in the standard procedure. The procedure should not take much longer than the standard goniotomy and the same amount of tissue will be cut as in a standard goniotomy. The needle is then removed. The remainder of the procedure is identical which includes placing a stitch in the corneal incision, adjusting the amount of fluid in the eye so the pressure is not too low or high, giving a dilating drop, giving a steroid and antibiotic injection around the eye, giving steroid ointment and an eye patch.

  Eligibility

Ages Eligible for Study:   up to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • childhood glaucoma with corneal edema unable to perform goniotomy

Exclusion Criteria:

  • older than 3 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00338533

Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: karen Joos, MD, PhD Vanderbilt University
  More Information

Publications:
Responsible Party: Karen Joos, Associate Professor of Ophthalmology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00338533     History of Changes
Other Study ID Numbers: Vanderbilt IRB # 8542
Study First Received: June 15, 2006
Last Updated: January 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
childhood glaucoma

Additional relevant MeSH terms:
Glaucoma
Hydrophthalmos
Congenital Abnormalities
Eye Abnormalities
Eye Diseases
Glaucoma, Open-Angle
Infant, Newborn, Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on November 27, 2014