Relationship Between Topiramate Use and Ocular Angle Status

Verified by: Chinese University of Hong Kong, October 2007
First Received: September 8, 2005 | Last Updated: October 30, 2007 | Phase: Phase 4 | Start Date: September 2004
Overall Status: Active, not recruiting | Estimated Enrollment: 15
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We test the hypothesis whether topiramate narrows the angles which may render Asians more likely to suffer from acute angle closure glaucoma...

Brief Summary

Official Title: “Relationship Between Topiramate Use and Ocular Angle Status: A Prospective Pilot Study”

We test the hypothesis whether topiramate narrows the angles which may render Asians more likely to suffer from acute angle closure glaucoma.

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Detailed Clinical Trial 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.

Intervention(s) in this Clinical Trial

  • Drug: Topiramate

Outcome Measures for this Clinical Trial

Primary Measures

  • Change(s) in ophthalmic parameters measured at baseline and after 4 weeks of treatment, including:
    • Time Frame: 4 weeks
  • best-corrected visual acuity, refraction, Goldmann applanation tonometry, Gonioscopy, dilated fundus examination,
    • Time Frame: 4 weeks
  • and ultrasound biomicroscopy of angle and anterior segment.
    • Time Frame: 4 weeks

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Chinese University of Hong Kong Other

Overall Clinical Trial Officials and Contacts

Dexter YL Leung, MRCS Principal Investigator Hong Kong Eye Hospital  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00153699

Study ID Number: CRE-2004.310

ClinicalTrials.gov Identifier: NCT00153699

Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00153699