Relationship Between Topiramate Use and Ocular Angle Status | NCT00153699

Studies
Relationship Between Topiramate Use and Ocular Angle Status

NCT00153699

Sponsor

Chinese University of Hong Kong

Status

Unknown status

Last Update Posted

Oct 31, 2007Estimated

Enrollment

15Estimated

Phase

Phase 4

Conditions

Glaucoma, Angle-Closure

Interventions

Topiramate

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2004

Primary Completion Date

Not provided

Completion Date

Jul 2007Estimated

First Submitted Date

Sep 8, 2005

First Submission Date that Met QC Criteria

Sep 8, 2005

First Posted Date

Sep 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 30, 2007

Last Update Posted Date

Oct 31, 2007Estimated

Name	Class
Hong Kong Eye Hospital	OTHER

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Name	Type	Description	Arm Group Labels	Other Names
Topiramate	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hong Kong Eye Hospital		Kowloon			Hong Kong
Prince of Wales Hospital

Condition Browse Module

MeSH Terms

ID	Term
D015812	Glaucoma, Angle-Closure

Ancestor Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077236	Topiramate

Ancestor Terms

ID	Term
D005632	Fructose
D006601	Hexoses
D009005	Monosaccharides
D000073893	Sugars
D002241

Browse Leaves

Not provided

Browse Branches

Not provided