NCT00321386

Brief Summary

To obtain demographic and baseline ophthalmic parameters (such as Intraocular Pressure profiles, disc morphological characteristics, central corneal thickness, peripapillary retinal nerve fibre layer thickness and its serial changes, visual field changes, severity of any medical associations-e.g. hypertension, migraine, strokes, silent cerebral infarcts) with non-invasive measurements, in Chinese Patients with Normal Tension Glaucoma

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
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2003

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

June 28, 2011

Status Verified

June 1, 2011

Enrollment Period

5 years

First QC Date

May 1, 2006

Last Update Submit

June 27, 2011

Conditions

Keywords

GlaucomaOpen AngleNormal Tension

Eligibility Criteria

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

Patients with Normal Tension Glaucoma recruited from a teritary University Eye Hospital setting.

You may qualify if:

  • All Chinese patients with age\>18 years old with Normal Tension Glaucoma will be recruited

You may not qualify if:

  • Diseases that precluded accurate measurement of IOP, visual acuity, retinal nerve fiber layer thickness, and visual field tests.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hong Kong Eye Hospital

Hong Kong, Hong Kong

RECRUITING

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (5)

  • Drance S, Anderson DR, Schulzer M; Collaborative Normal-Tension Glaucoma Study Group. Risk factors for progression of visual field abnormalities in normal-tension glaucoma. Am J Ophthalmol. 2001 Jun;131(6):699-708. doi: 10.1016/s0002-9394(01)00964-3.

    PMID: 11384564BACKGROUND
  • Leung DY, Tham CC, Li FC, Kwong YY, Chi SC, Lam DS. Silent cerebral infarct and visual field progression in newly diagnosed normal-tension glaucoma: a cohort study. Ophthalmology. 2009 Jul;116(7):1250-6. doi: 10.1016/j.ophtha.2009.02.003. Epub 2009 May 30.

  • Leung DY, Li FC, Kwong YY, Tham CC, Chi SC, Lam DS. Simvastatin and disease stabilization in normal tension glaucoma: a cohort study. Ophthalmology. 2010 Mar;117(3):471-6. doi: 10.1016/j.ophtha.2009.08.016. Epub 2010 Jan 4.

  • Leung DY, Kwong YY, Li FC, Tham CC, Chi SC, Lam DS. Comparison of the clinical characteristics of normal tension glaucoma patients with pretreatment intraocular pressures in the high-teens and low-teens. Br J Ophthalmol. 2010 May;94(5):663-5. doi: 10.1136/bjo.2009.163014. No abstract available.

  • Leung DY, Iliev ME, Chan P, Baig N, Chi SC, Tham CC, Lam DS. Pressure-cornea-vascular index (PCVI) for predicting disease progression in normal tension glaucoma. Br J Ophthalmol. 2011 Aug;95(8):1106-10. doi: 10.1136/bjo.2009.175992. Epub 2010 Aug 7.

Biospecimen

Retention: SAMPLES WITH DNA

Blood taking for glaucoma genetics analysis shall be performed.

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • LEUNG YL Dexter, MBChB, FRCS

    Glaucoma Service, Hong Kong Eye Hospital

    PRINCIPAL INVESTIGATOR
  • LAM SC Dennis, MD, FRCOphth

    Chinese University of Hong Kong

    STUDY CHAIR

Central Study Contacts

LEUNG YL Dexter, MBChB, FRCS

CONTACT

Study Design

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

Study Record Dates

First Submitted

May 1, 2006

First Posted

May 3, 2006

Study Start

December 1, 2003

Primary Completion

December 1, 2008

Study Completion

December 1, 2012

Last Updated

June 28, 2011

Record last verified: 2011-06

Locations