NCT00742196

Brief Summary

Retinal nerve fiber layer (RNFL) thickness measurement on the parapapillary atrophy is incorrect. Because a new spectral domain OCT, the Cirrus HD OCT, uses a movable circle to analyze the RNFL thickness, we may suggest a new analysis strategy for the parapapillary atrophy.

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 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

First Submitted

Initial submission to the registry

August 26, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 27, 2008

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

August 27, 2008

Status Verified

August 1, 2008

Enrollment Period

3 months

First QC Date

August 26, 2008

Last Update Submit

August 26, 2008

Conditions

Glaucoma

Keywords

Parapapillary atrophyRetinal nerve fiber layer thicknessGlaucomaCirrus OCT

Outcome Measures

Primary Outcomes (2)

  • Retinal nerve fiber layer thickness

    when the OCT images are taking

  • Size of parapapillary atrophy

    when the OCT images are taking

Study Arms (2)

1

No parapapillary atrophy

2

Parapapillary atrophy

Eligibility Criteria

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

Subjects with or without parapapillary atrophy

You may qualify if:

  • Qualified OCT images (signal strength \> or = 8)

You may not qualify if:

  • Previous intraocular surgery history
  • Media opacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gong Je Seong

Seoul, 135-720, South Korea

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Gong Je Seong, MD, PhD

    Yonsei University

    PRINCIPAL INVESTIGATOR

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

August 26, 2008

First Posted

August 27, 2008

Study Start

September 1, 2008

Primary Completion

December 1, 2008

Study Completion

March 1, 2009

Last Updated

August 27, 2008

Record last verified: 2008-08

Locations

KR(1)