Back to resultsRelationship Between Topiramate Use and Ocular Angle Status
Primary Purpose
Glaucoma, Angle-Closure
Status
Unknown status
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
Topiramate
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma, Angle-Closure focused on measuring Side effects, Topiramate
Eligibility Criteria
Inclusion Criteria: Participants aged 18-75 with an indication for starting topiramate. Exclusion Criteria: Patients with known allergy or intolerance to topiramate. Recent exposure to topiramate (<3 months). Moderate to severe renal failure. Known history of renal calculi or hepatic failure Inability to give informed consent. Pregnant women or women of child-bearing age who do not practise an acceptable means of contraception. Patients known to have angle-closure glaucoma.
Sites / Locations
- Hong Kong Eye Hospital
- Prince of Wales Hospital
Outcomes
Primary Outcome Measures
Change(s) in ophthalmic parameters measured at baseline and after 4 weeks of treatment, including:
best-corrected visual acuity, refraction, Goldmann applanation tonometry, Gonioscopy, dilated fundus examination,
and ultrasound biomicroscopy of angle and anterior segment.
Secondary Outcome Measures
Full Information
NCT ID
NCT00153699
First Posted
September 8, 2005
Last Updated
October 30, 2007
Sponsor
Chinese University of Hong Kong
Collaborators
Hong Kong Eye Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00153699
Brief Title
Relationship Between Topiramate Use and Ocular Angle Status
Official Title
Relationship Between Topiramate Use and Ocular Angle Status: A Prospective Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Unknown status
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
Hong Kong Eye Hospital
4. Oversight
5. Study Description
Brief Summary
We test the hypothesis whether topiramate narrows the angles which may render Asians more likely to suffer from acute angle closure glaucoma.
Detailed Description
Topiramate is approved for the treatment of epilepsy and prophylaxis of migraine attacks. There were case reports of acute angle closure glaucoma (AACG) associated with its use. AACG is particularly common in Asians because of a higher prevalence of narrow angle., we test the hypothesis whether topiramate narrows the angles which may render them more likely to suffer from AACG.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Angle-Closure
Keywords
Side effects, Topiramate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Topiramate
Primary Outcome Measure Information:
Title
Change(s) in ophthalmic parameters measured at baseline and after 4 weeks of treatment, including:
Time Frame
4 weeks
Title
best-corrected visual acuity, refraction, Goldmann applanation tonometry, Gonioscopy, dilated fundus examination,
Time Frame
4 weeks
Title
and ultrasound biomicroscopy of angle and anterior segment.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants aged 18-75 with an indication for starting topiramate.
Exclusion Criteria:
Patients with known allergy or intolerance to topiramate.
Recent exposure to topiramate (<3 months).
Moderate to severe renal failure.
Known history of renal calculi or hepatic failure
Inability to give informed consent.
Pregnant women or women of child-bearing age who do not practise an acceptable means of contraception.
Patients known to have angle-closure glaucoma.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dexter YL Leung, MRCS
Organizational Affiliation
Hong Kong Eye Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Howan Leung, MRCP
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hong Kong Eye Hospital
City
Kowloon
Country
Hong Kong
Facility Name
Prince of Wales Hospital
City
Shatin
Country
Hong Kong
12. IPD Sharing Statement
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Relationship Between Topiramate Use and Ocular Angle Status
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