NCT01316003

Brief Summary

The aim of this study is to investigate the incidence and possible causes of obscured or disrupted cone outer segment tips line at fovea in spectral-domain optical coherence tomography images of normal eyes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 16, 2011

Completed
Last Updated

August 2, 2012

Status Verified

July 1, 2012

Enrollment Period

1 year

First QC Date

March 15, 2011

Last Update Submit

July 31, 2012

Conditions

Healthy

Keywords

cone outer segment tips lineOptical coherence tomography

Outcome Measures

Primary Outcomes (1)

  • Microstructural analysis by Spectral domain optical coherence tomography

    SD-OCT images of 6 mm scans were taken using Cirrus HD-OCT (OCT 4000, Carl Zeiss Meditec, Dublin, CA) with 5 line raster (5LR) and high-definition 5 line raster (HD5LR) modes.

    one year

Secondary Outcomes (1)

  • Visual acuity

    one year

Study Arms (1)

Normal subjects

Thirty-seven eyes of 37 individuals without eye diseases

Other: Optical coherence tomography

Interventions

Optical coherence tomographyOTHER

Optical coherence tomography

Also known as: Cirrus HD-OCT (Carl Zeiss Meditec)
Normal subjects

Eligibility Criteria

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

Thirty-seven eyes of 37 individuals without eye diseases

You may qualify if:

  • individuals without eye diseases

You may not qualify if:

  • individuals with eye diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyorin Eye Center

Mitaka, Tokyo, 181-8611, Japan

Location

Related Publications (1)

  • Rii T, Itoh Y, Inoue M, Hirakata A. Foveal cone outer segment tips line and disruption artifacts in spectral-domain optical coherence tomographic images of normal eyes. Am J Ophthalmol. 2012 Mar;153(3):524-529.e1. doi: 10.1016/j.ajo.2011.08.021. Epub 2011 Oct 21.

    PMID: 22018706DERIVED

MeSH Terms

Interventions

Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Makoto Inoue, MD

    Kyorin Eye Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 15, 2011

First Posted

March 16, 2011

Study Start

March 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

August 2, 2012

Record last verified: 2012-07

Locations

JP(1)