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GlaucomaNCT00324181

Psychopathology of Normal-tension Glaucoma in Hong Kong Chinese Out-patient

An observational study of Glaucoma, run by Chinese University of Hong Kong at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

It is suggested the pathogenesis of normal-tension glaucoma (NTG) involves vascular dysregulation. In the past studies, it is well documented that many physical problems related to vascular dysregulation, such as angina pectoris (Friedman M et al 1974; Russek HI et al 1976), migraine (Diener HC et al 1994), primary… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Glaucoma
How many people
100 participants
Where
1 siteChina
Study dates
Jun 2006to Jun 2010
Phase
Observational
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Glaucoma patients from a tertiary University Ophthalmic clinic setting

Who may be able to join

  • Cantonese-speaking Chinese
  • Aged from 18 to 65
  • Attending university-affiliated glaucoma clinic from August, 2005 to June, 2006 with written consent Inclusion criteria of control
  • Those just receiving routine fundi examination without any ophthalmologic follow-up afterwards
  • Cantonese-speaking Chinese
  • Aged from 18 to 65
  • With written consent

Who cannot join

  • Psychoses
  • Psychiatric condition warranting hospitalization Exclusion criteria of control
  • Previous or current ocular or general acute or chronic disease
  • Taking any medication
  • Psychoses
  • Psychiatric condition warranting hospitalization

Trial locations and contacts

1 site in 1 country.

China1 site
  • Department of Psychiatry, Kowloon Hospital, Hong Kong

    Hong Kong

Other trials in China

About this study

It is suggested the pathogenesis of normal-tension glaucoma (NTG) involves vascular dysregulation. In the past studies, it is well documented that many physical problems related to vascular dysregulation, such as angina pectoris (Friedman M et al 1974; Russek HI et al 1976), migraine (Diener HC et al 1994), primary Raynaud's disease (Wagner HH et al 1993) and stroke (Gainotti G, et al, 2001; Hayee Ma et al 2001), are associated with a high risk of depressive illness. So, NTG, being a disease involving vascular dysregulation, is postulated to be associated with psychopathology.

Glaucoma increases after 40 year-old and the number of people over this age in Hong Kong is rapidly growing. However, we have no knowledge about the link between psychopathology and NTG in Hong Kong. The present study is sought to overcome the limitation in previous research and the goals of present study are:

Read more
  • To identify the prevalence of psychopathology of normal-tension glaucoma Hong Kong Chinese Out-patients attending a university-affiliated glaucoma clinic.
  • To determine whether there are any differences among NTG patients, patients with glaucoma other than NTG and control in terms of psychopathology and quality of life.

Designs:

Case-control study to compare among patients with normal-tension glaucoma (NTG), patients with glaucoma other than normal-tension glaucoma (OTNTG) and control in terms of psychopathology and quality of life

Read the detailed description

Patients with chronic medical illness have been shown to have higher rates of depression and other psychopathology (Kimmel PL et al, 1998; Amato L et al, 1996). Glaucoma is a chronic, progressive ophthalmologic disease. Treatment may involve the use of multiple medications and surgery. Despite therapy, many patients continue to worsen, and some may even lose vision. Because of this threat of potential loss of vision and the known depression-related side effects of some of topical glaucoma medication, particular beta-blocker (Cove-Smith JR et al, 1985), it can be necessary hypothesized that glaucoma patient may have an increased prevalence of depression and other psychopathology. It is also reasonable to apply similar hypothesis on the patients with normal-tension glaucoma.

Normal-tension glaucoma (NTG) is a type of open-angle glaucoma defined as an optic neuropathy with visual-field defects together normal distribution of intraocular pressure (<21 mmHg) over a period of twenty-four hour as well as normal chamber-angle anatomy (Levene RZ, 1980). NTG is associated with different vasospastic syndrome including higher incidence of migraine (Phelps CD et al, 1985), angina pectoris (Goldberg I et al, 1981), silent myocardial ischemia (Kaiser HJ et al, 1993) and ocular vasopasm (Flammer J et al, 1991; Flammer J et al 1987; Orgul S et al 1995). Such associated clinical characteristics suggest that the pathogenesis of NTG involves vascular dysregulation. In the past studies, it is well documented that many physical problems related to vascular dysregulation, such as angina pectoris (Friedman M et al 1974; Russek HI et al 1976), migraine (Diener HC et al 1994), primary Raynaud's disease (Wagner HH et al 1993) and stroke (Gainotti G, et al, 2001; Hayee Ma et al 2001), are associated with a high risk of depressive illness. So, NTG, being a disease involving vascular dysregulation, is postulated to be associated with psychopathology.

Conditions
Glaucoma
Keywords
normal-tension glaucoma, psychopathology, Hong Kong
Medical subject headings
Glaucoma, Low Tension Glaucoma

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2006 (estimated)
  2. Study startJun 2006
  3. Primary completionJun 2010 (estimated)
  4. Study completionJun 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00324181
Sponsor's protocol ID
CRE-2006.060
Status last verified
Aug 2009
First submitted
8 May 2006
Last updated
4 Aug 2009
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Glaucoma, run by Chinese University of Hong Kong at 1 site in China.

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 7 inclusion and 6 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 4 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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.

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.

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 4 Aug 2009.

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