Relationship Between Topiramate Use and Ocular Angle Status

Glaucoma, Angle-Closure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00153699
• Other study ID #: CRE-2004.310
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 8, 2005
• Last updated: October 30, 2007
• Start date: September 2004
• Est. completion date: July 2007

Study information

• Verified date: October 2007
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

We test the hypothesis whether topiramate narrows the angles which may render Asians more likely to suffer from acute angle closure glaucoma.

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.

Other known NCT identifiers

• NCT00518063

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma, Angle-Closure

Intervention

Drug:
• Topiramate

Locations

Country	Name	City	State
Hong Kong	Hong Kong Eye Hospital	Kowloon
Hong Kong	Prince of Wales Hospital	Shatin

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Hong Kong Eye Hospital

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change(s) in ophthalmic parameters measured at baseline and after 4 weeks of treatment, including:		4 weeks
Primary	best-corrected visual acuity, refraction, Goldmann applanation tonometry, Gonioscopy, dilated fundus examination,		4 weeks
Primary	and ultrasound biomicroscopy of angle and anterior segment.		4 weeks