NCT00772993

Brief Summary

Glaucoma is presumed to be an axonal disease which starts at the lamina cribrosa. This assumption has led to the monitoring of the retinal nerve fiber layer thickness for the diagnosis and monitoring of progression of glaucoma. However, varying disc size, myopia and tilted discs affect the thickness of the retinal nerve fiber layer. This study aims to ascertain the ration of the retinal nerve fiber layer against full retina as a predictor of glaucoma diagnosis and progression.

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
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2008

Shorter than P25 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

Study Start

First participant enrolled

October 1, 2008

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

October 16, 2008

Status Verified

October 1, 2008

Enrollment Period

2 months

First QC Date

October 15, 2008

Last Update Submit

October 15, 2008

Conditions

GlaucomaMyopia

Keywords

glaucomamyopiamyopia with glaucomanormal control

Outcome Measures

Primary Outcomes (1)

  • Ratio of RNFL / Full thickness retina

    2 months

Study Arms (4)

1

Primary open angle glaucoma

2

Normal Control

3

Myopia with no evidence of glaucoma

4

Myopia with evidence og glaucoma

Eligibility Criteria

Age10 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

prospective consecutive recruitment from a tertialry glaucoma subspecialty practise

You may qualify if:

  • Primary open angle glaucoma
  • Myopia
  • Myopia with evidence of glaucoma
  • Normal controls

You may not qualify if:

  • Evidence of retinal disease
  • BCVA \< 0.4
  • Secondary glaucoma due to intraocular inflammation
  • Lens induced glaucoma
  • Tumor induced glaucoma
  • Neovascular glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Vision Research, Department of Ophthalmology, Severance Hospital, Yonsei University School of Medicine

Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Conditions

GlaucomaMyopia

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesRefractive Errors

Central Study Contacts

Chan Yun Kim, MD,PhD.

CONTACT

82-2-2228-3570kangeye@hotmail.com

Sung Yong Kang, MD

CONTACT

82-2-2228-3570kangeye@yuhs.ac

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 15, 2008

First Posted

October 16, 2008

Study Start

October 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

October 16, 2008

Record last verified: 2008-10

Locations

KR(1)