GlaucomaNCT00338533
Endoscopic Goniotomy for Infantile Glaucoma
A study testing endoscopic goniotomy in people with Glaucoma, run by Vanderbilt University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 week to 3 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- endoscopic goniotomy
- Type of treatment
- Medical device
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1997to Jul 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- childhood glaucoma with corneal edema unable to perform goniotomy
Who cannot join
- older than 3 years
Trial locations and contacts
1 site in 1 country.
About this study
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 .
Read the detailed description
- 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.
- Conditions
- Glaucoma
- Being tested
- endoscopic goniotomy
- Keywords
- childhood glaucoma
- Medical subject headings
- Glaucoma, Hydrophthalmos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic goniotomyDevice
The goninotomy is performed through an endoscope; allowing the physician a better view of the structure within the eye
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure reduction
Measured: Postoperatively
Secondary outcomes (1)
Clearing of corneal edema
Measured: Postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startApr 1997
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Joos, Vanderbilt University
- Investigators
- karen Joos, MD, PhD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00338533
- Sponsor's protocol ID
- Vanderbilt IRB # 8542
- Status last verified
- Jan 2013
- First submitted
- 15 Jun 2006
- Last updated
- 8 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Joos KM, Shen JH. An ocular endoscope enables a goniotomy despite a cloudy cornea. Arch Ophthalmol. 2001 Jan;119(1):134-5. No abstract available.
PubMed 11146740
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Goniotomy for Infantile Glaucoma
- ClinicalTrials.gov ID
- NCT00338533
- Acronym / sponsor ID
- Vanderbilt IRB # 8542
- Conditions
- Glaucoma
- Keywords
- childhood glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Apr 1997
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 20 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Detailed description
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 week to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- childhood glaucoma with corneal edema unable to perform goniotomy
Key exclusion criteria (1 listed)
- older than 3 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopic goniotomyThe goninotomy is performed through an endoscope; allowing the physician a better view of the structure within the eye | Device | – |
Primary outcome
Intraocular pressure reduction
Time frame: Postoperatively
1 secondary outcome
Clearing of corneal edema
Time frame: Postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2013.
- Results publication: PubMed 11146740Joos KM, Shen JH. An ocular endoscope enables a goniotomy despite a cloudy cornea. Arch Ophthalmol. 2001 Jan;119(1):134-5. No abstract available.
Related trials for Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma
Recruiting
Inflammatory Mediators of Glaucoma After Corneal Transplantation (AH-Tears)
Glaucoma, Corneal Transplantation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
karen Joos, MD, PhD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic goniotomy in people with Glaucoma, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure reduction (time frame: Postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00338533, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2013.