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Relationship Between Topiramate Use and Ocular Angle Status

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2007 by Chinese University of Hong Kong.
Recruitment status was:  Active, not recruiting
Sponsor:
Collaborator:
Hong Kong Eye Hospital
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00153699
First received: September 8, 2005
Last updated: October 30, 2007
Last verified: October 2007
  Purpose
We test the hypothesis whether topiramate narrows the angles which may render Asians more likely to suffer from acute angle closure glaucoma.

Condition Intervention Phase
Glaucoma, Angle-Closure Drug: Topiramate Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Relationship Between Topiramate Use and Ocular Angle Status: A Prospective Pilot Study

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome 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 ]

Estimated Enrollment: 15
Study Start Date: September 2004
Estimated Study Completion Date: July 2007
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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  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: NCT00153699

Locations
Hong Kong
Hong Kong Eye Hospital
Kowloon, Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Hong Kong Eye Hospital
Investigators
Principal Investigator: Dexter YL Leung, MRCS Hong Kong Eye Hospital
Principal Investigator: Howan Leung, MRCP Chinese University of Hong Kong
  More Information

ClinicalTrials.gov Identifier: NCT00153699     History of Changes
Obsolete Identifiers: NCT00518063
Other Study ID Numbers: CRE-2004.310
Study First Received: September 8, 2005
Last Updated: October 30, 2007

Keywords provided by Chinese University of Hong Kong:
Side effects
Topiramate

Additional relevant MeSH terms:
Glaucoma, Angle-Closure
Glaucoma
Ocular Hypertension
Eye Diseases
Topiramate
Anticonvulsants
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents

ClinicalTrials.gov processed this record on June 28, 2017