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Relationship Between Topiramate Use and Ocular Angle Status - Article


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Glaucoma


Clinical Trial: Relationship Between Topiramate Use and Ocular Angle Status

This study has been completed.

Sponsors and Collaborators: Chinese University of Hong Kong
Hong Kong Eye Hospital
Information provided by: Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00153699

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 IV

MedlinePlus related topics:  Glaucoma

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

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

Further Study Details: 
Primary Outcomes: 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; - Ultrasound biomicroscopy of angle and anterior segment
Expected Total Enrollment:  15

Study start: September 2004;  Study completion: May 2005
Last follow-up: February 2005;  Data entry closure: April 2005

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   -   75 Years,  Genders Eligible for Study:  Both
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.

Location Information


Hong Kong
      Prince of Wales Hospital, Shatin,  Hong Kong

      Hong Kong Eye Hospital, Kowloon,  Hong Kong

Study chairs or principal investigators

Dexter YL Leung, MRCS,  Principal Investigator,  Hong Kong Eye Hospital   
Howan Leung, MRCP,  Principal Investigator,  Chinese University of Hong Kong   

More Information

Study ID Numbers:  CRE-2004.310
Last Updated:  September 9, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00153699
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
ClinicalTrials.gov processed this record on 2005-09-13


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