Relationship Between Topiramate Use and Ocular Angle Status

This study is ongoing, but not recruiting participants.

First Received: September 8, 2005 Last Updated: October 30, 2007 History of Changes

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

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

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Topiramate

U.S. FDA Resources

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
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00153699

Locations

Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong
Hong Kong Eye Hospital
Kowloon, 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

No publications provided

Study ID Numbers:	CRE-2004.310
Study First Received:	September 8, 2005
Last Updated:	October 30, 2007
ClinicalTrials.gov Identifier:	NCT00153699 History of Changes
Health Authority:	Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:

Side effects
Topiramate

Study placed in the following topic categories:

Anti-Obesity Agents
Glaucoma
Eye Diseases
Topiramate
Glaucoma, Angle-Closure

Neuroprotective Agents
Anticonvulsants
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Eye Diseases
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Pharmacologic Actions
Anti-Obesity Agents
Glaucoma

Therapeutic Uses
Topiramate
Glaucoma, Angle-Closure
Central Nervous System Agents
Anticonvulsants
Ocular Hypertension

ClinicalTrials.gov processed this record on July 02, 2009