Relationship Between Topiramate Use and Ocular Angle Status - Tabular View

Tracking Information

First Received Date ^ICMJE

September 8, 2005

Last Updated Date

October 30, 2007

Start Date ^ICMJE

September 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Change(s) in ophthalmic parameters measured at baseline and after 4 weeks of treatment, including:
- Goldmann applanation tonometry
- Ultrasound biomicroscopy of angle and anterior segment
- Best-corrected visual acuity
- Refraction
- Gonioscopy
- Dilated fundus examination

Change History

Complete list of historical versions of study NCT00153699 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Relationship Between Topiramate Use and Ocular Angle Status

Official Title ^ICMJE

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

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Condition ^ICMJE

Glaucoma, Angle-Closure

Intervention ^ICMJE

Drug: Topiramate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Hong Kong

Administrative Information

NCT ID ^ICMJE

NCT00153699

Responsible Party

Study ID Numbers ^ICMJE

CRE-2004.310

Study Sponsor ^ICMJE

Chinese University of Hong Kong

Collaborators ^ICMJE

Hong Kong Eye Hospital

Investigators ^ICMJE

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

Information Provided By

Chinese University of Hong Kong

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP