We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Relationship Between Topiramate Use and Ocular Angle Status

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00153699
Recruitment Status : Unknown
Verified October 2007 by Chinese University of Hong Kong.
Recruitment status was:  Active, not recruiting
First Posted : September 12, 2005
Last Update Posted : October 31, 2007
Sponsor:
Collaborator:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Glaucoma, Angle-Closure Drug: Topiramate Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relationship Between Topiramate Use and Ocular Angle Status: A Prospective Pilot Study
Study Start Date : September 2004
Estimated Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Glaucoma
Drug Information available for: Topiramate
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: October 31, 2007
Last Verified: October 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