NCT00741130

Brief Summary

Because the measurement of the retinal nerve fiber layer thickness is very sensitive to the position of measurement, it may be incorrect in patients with the tilted disc. In the present study, the corrected RNFL thickness by the optic nerve head configuration using the Cirrus HD OCT will be evaluated. If the corrected RNFL thickness is more sensitive to detect the localized RNFL defect, the present software should be upgrade to reflect the optic nerve head configuration.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

August 26, 2008

Status Verified

August 1, 2008

Enrollment Period

3 months

First QC Date

August 25, 2008

Last Update Submit

August 25, 2008

Conditions

GlaucomaMyopia

Keywords

retinal nerve fiber layeroptic nerve headCirrus OCT

Outcome Measures

Primary Outcomes (1)

  • the Cirrus HD OCT

    when the OCT images are taking

Secondary Outcomes (3)

  • automated visual field

    when the OCT images are taking

  • red-free fundus photo

    when the OCT images are taking

  • refractive errors

    when the OCT images are taking

Study Arms (2)

C

normal volunteers

G

glaucoma patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Volunteers of our opthalmologic clinic

You may qualify if:

  • normal controls or glaucoma patients
  • signal intensity of the OCT image \> 8
  • cooperative subjects

You may not qualify if:

  • spherical equivalent refractive errors \> +4 diopters or \< -4 diopters
  • significant media opacity
  • previous intraocular surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gong Je Seong

Seoul, 135-720, South Korea

RECRUITING

MeSH Terms

Conditions

GlaucomaMyopia

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesRefractive Errors

Study Officials

  • Gong Je Seong, MD, PhD

    Yonsei University

    STUDY CHAIR

Central Study Contacts

Gong Je Seong, MD, PhD

CONTACT

82-2-2019-3441gjseong@yuhs.ac

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 25, 2008

First Posted

August 26, 2008

Study Start

July 1, 2008

Primary Completion

October 1, 2008

Study Completion

January 1, 2009

Last Updated

August 26, 2008

Record last verified: 2008-08

Locations

KR(1)