NCT00324181

Brief 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 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

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2006

Completed
22 days until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

August 4, 2009

Status Verified

August 1, 2009

Enrollment Period

4 years

First QC Date

May 8, 2006

Last Update Submit

August 3, 2009

Conditions

Keywords

normal-tension glaucomapsychopathologyHong Kong

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Glaucoma patients from a tertiary University Ophthalmic clinic setting

You may qualify if:

  • Cantonese-speaking Chinese
  • Aged from 18 to 65
  • Those just receiving routine fundi examination without any ophthalmologic follow-up afterwards
  • Cantonese-speaking Chinese
  • Aged from 18 to 65
  • With written consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, Kowloon Hospital, Hong Kong

Hong Kong, China

Location

MeSH Terms

Conditions

GlaucomaLow Tension Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesOptic Nerve Diseases

Study Officials

  • Karina Chan, MBChB, MRCPsych

    Department of Psychiatry, Kowloon Hospital, Hong Kong

    PRINCIPAL INVESTIGATOR
  • Dexter Leung, MBChB, FRCS

    Chinese University of Hong Kong

    STUDY DIRECTOR
  • Sing Lee, MD, MRCPsych

    Department of Psychiatry, CUHK

    STUDY DIRECTOR
  • Dennis Lam, MD, FRCOphth

    Chinese University of Hong Kong

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 8, 2006

First Posted

May 10, 2006

Study Start

June 1, 2006

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

August 4, 2009

Record last verified: 2009-08

Locations