NCT00766389

Brief Summary

The Cirrus HD OCT, a new spectral domain optical coherence tomography (OCT), has better resolution than the previous time domain Stratus OCT. Discriminating ability of these two OCTs for diagnosis of glaucoma and judgement of disease progression will be studied.

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
200

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

October 6, 2008

Status Verified

October 1, 2008

Enrollment Period

2 months

First QC Date

October 3, 2008

Last Update Submit

October 3, 2008

Conditions

Glaucoma

Keywords

GlaucomaRetinal nerve fiber layerCirrus OCTStratus OCT

Outcome Measures

Primary Outcomes (1)

  • Retinal nerve fiber layer thickness

    When the OCT images are taking

Secondary Outcomes (4)

  • Visual field

    When the OCT images are taking

  • Red-free fundus photo

    When the OCT images are taking

  • Intraocular pressure

    When the OCT images are taking

  • Central corneal thickness

    When the OCT images are taking

Study Arms (2)

1

Defined glaucoma patients

2

Glaucoma suspects and normal controls

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Defined glaucoma patients and glaucoma suspects

You may qualify if:

  • Retinal nerve fiber layer analysis with Cirrus OCT and Stratus OCT within 1 month

You may not qualify if:

  • Intraocular surgeries history
  • High refractive error ( \< -4.00 diopters, or \> + 4.00 diopters)
  • Media opacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gong Je Seong

Seoul, 135-720, South Korea

RECRUITING

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

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 CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 3, 2008

First Posted

October 6, 2008

Study Start

October 1, 2008

Primary Completion

December 1, 2008

Study Completion

February 1, 2009

Last Updated

October 6, 2008

Record last verified: 2008-10

Locations

KR(1)