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.
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.
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.
- First posted10 May 2006 (estimated)
- Study startJun 2006
- Primary completionJun 2010 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Karina Chan, MBChB, MRCPsych, Principal investigator, Department of Psychiatry, Kowloon Hospital, Hong KongDexter Leung, MBChB, FRCS, Study director, Chinese University of Hong KongSing Lee, MD, MRCPsych, Study director, Department of Psychiatry, CUHKDennis Lam, MD, FRCOphth, Study chair, Chinese University of Hong Kong
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychopathology of Normal-tension Glaucoma in Hong Kong Chinese Out-patient
- ClinicalTrials.gov ID
- NCT00324181
- Acronym / sponsor ID
- CRE-2006.060
- Conditions
- Glaucoma
- Keywords
- normal-tension glaucoma, psychopathology, Hong Kong
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 10 May 2006 (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.
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:
- 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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Glaucoma patients from a tertiary University Ophthalmic clinic setting
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- Psychoses
- Psychiatric condition warranting hospitalization Exclusion criteria of control
- Previous or current ocular or general acute or chronic disease
- Taking any medication
- Psychoses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2009.
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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.
Karina Chan, MBChB, MRCPsych principal investigator
Department of Psychiatry, Kowloon Hospital, Hong Kong
Dexter Leung, MBChB, FRCS study director
Chinese University of Hong Kong
Sing Lee, MD, MRCPsych study director
Department of Psychiatry, CUHK
1 site in 1 country: see every site and its status.
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.