NCT00838422

Brief Summary

The purpose of this study is to assess the repeatability, reproducibility, and agreement of central corneal thickness measured by Fourier Domain Optical Coherence tomography (FD-OCT, OptoVue, USA) with anterior corneal module, 20MHz ultrasound pachymetry equipped with Ocular response analyzer (ORA, Reichert Ophthalmic Instruments, USA) and 10MHz Ultrasound Pachymetry (USP).

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 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

June 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 6, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

February 6, 2009

Status Verified

February 1, 2009

Enrollment Period

7 months

First QC Date

February 4, 2009

Last Update Submit

February 5, 2009

Conditions

Keratitis

Outcome Measures

Primary Outcomes (1)

  • Repeatability and reproducibility of corneal thickness measurement

    3 months

Secondary Outcomes (1)

  • Comparing central corneal thickness measurement among FD-OCT, ORA, and USP

    3 months

Study Arms (1)

FD-OCT, ORA, USP

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteer who has no prior ocular disease history and prior intraocular surgical history

You may qualify if:

  • Healthy Volunteers

You may not qualify if:

  • Patients who had history of prior ocular surgery, ocular abnormalities other than cataract or refractive error or were unable to cooperate in the examination were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

Banqiao District, Taipei, 220, Taiwan

RECRUITING

MeSH Terms

Conditions

Keratitis

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Officials

  • Shu-Wen Chang, MD

    Far Eastern Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu-Wen Lo, MD

CONTACT

02-89667000swchang2007@ntu.edu.tw

Study Design

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

Study Record Dates

First Submitted

February 4, 2009

First Posted

February 6, 2009

Study Start

June 1, 2008

Primary Completion

January 1, 2009

Study Completion

June 1, 2009

Last Updated

February 6, 2009

Record last verified: 2009-02

Locations

TW(1)