NCT00153699

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2004

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

October 31, 2007

Status Verified

October 1, 2007

First QC Date

September 8, 2005

Last Update Submit

October 30, 2007

Conditions

Glaucoma, Angle-Closure

Keywords

Side effectsTopiramate

Outcome Measures

Primary Outcomes (3)

  • Change(s) in ophthalmic parameters measured at baseline and after 4 weeks of treatment, including:

    4 weeks

  • best-corrected visual acuity, refraction, Goldmann applanation tonometry, Gonioscopy, dilated fundus examination,

    4 weeks

  • and ultrasound biomicroscopy of angle and anterior segment.

    4 weeks

Interventions

TopiramateDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants aged 18-75 with an indication for starting topiramate.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hong Kong Eye Hospital

Kowloon, Hong Kong

Location

Prince of Wales Hospital

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Glaucoma, Angle-Closure

Interventions

Topiramate

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • Dexter YL Leung, MRCS

    Hong Kong Eye Hospital

    PRINCIPAL INVESTIGATOR

  • Howan Leung, MRCP

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

September 1, 2004

Study Completion

July 1, 2007

Last Updated

October 31, 2007

Record last verified: 2007-10

Locations

HK(2)