Glaucoma, Angle-ClosurePhase 4NCT00153699
Relationship Between Topiramate Use and Ocular Angle Status
A Phase 4 study testing Topiramate in people with Glaucoma, Angle-Closure, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
Trial summary
We test the hypothesis whether topiramate narrows the angles which may render Asians more likely to suffer from acute angle closure glaucoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glaucoma, Angle-Closure
- What is being tested?
- Topiramate
- How many people
- 15 participants
- Where
- 2 sitesHong Kong
- Study dates
- Sep 2004to Jul 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged 18-75 with an indication for starting topiramate.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Hong Kong Eye Hospital
Kowloon
Prince of Wales Hospital
Shatin
About this study
Official title: Relationship Between Topiramate Use and Ocular Angle Status: A Prospective Pilot Study
We test the hypothesis whether topiramate narrows the angles which may render Asians more likely to suffer from acute angle closure glaucoma.
Read the 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.
- Conditions
- Glaucoma, Angle-Closure
- Being tested
- Topiramate
- Keywords
- Side effects, Topiramate
- Medical subject headings
- Glaucoma, Angle-Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopiramateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change(s) in ophthalmic parameters measured at baseline and after 4 weeks of treatment, including:
Measured: 4 weeks
best-corrected visual acuity, refraction, Goldmann applanation tonometry, Gonioscopy, dilated fundus examination,
Measured: 4 weeks
and ultrasound biomicroscopy of angle and anterior segment.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startSep 2004
- Study completionJul 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Angle-ClosureStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hong Kong Eye Hospital
- Investigators
- Dexter YL Leung, MRCS, Principal investigator, Hong Kong Eye HospitalHowan Leung, MRCP, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153699
- Sponsor's protocol ID
- CRE-2004.310
- Status last verified
- Oct 2007
- First submitted
- 8 Sep 2005
- Last updated
- 31 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Topiramate Use and Ocular Angle Status: A Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT00153699
- Acronym / sponsor ID
- CRE-2004.310
- Conditions
- Glaucoma, Angle-Closure
- Keywords
- Side effects, Topiramate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Hong Kong Eye Hospital
- Study start
- Sep 2004
- Study completion
- Jul 2007 (estimated)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants aged 18-75 with an indication for starting topiramate.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topiramate | Drug | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dexter YL Leung, MRCS principal investigator
Hong Kong Eye Hospital
Howan Leung, MRCP principal investigator
Chinese University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topiramate in people with Glaucoma, Angle-Closure, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change(s) in ophthalmic parameters measured at baseline and after 4 weeks of treatment, including: (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2007.