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CompletedNCT01316003Updated Aug 2, 2012

Distinction of Cone Outer Segment Tips by Spectral-Domain Optical Coherence Tomography in Normal Eyes

An observational study in Healthy, sponsored by Kyorin University. Completed at 1 site in Japan. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-08-02.

Sponsored by Kyorin University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
37
Ages
20 Years to 80 Years
Sex
All
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Study 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.

Read the detailed description

Thirty-seven eyes of 37 individuals without eye diseases were included in this study. Optical Coherence Tomography (OCT) images were taken using Cirrus HD-OCT (Carl Zeiss Meditec) with 5 line raster and high-definition 5 line raster modes. Images with signal strength weaker than 5/10 were excluded. Distinction of COST line and the integrity of COST line, external limiting membrane, and the photoreceptor inner segment and outer segment junction at the fovea were recorded. Demographic data, refractive error of the eyes, signal strengths of the OCT images were acquired for analysis.

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Conditions studied

  • Healthy

Keywords

  • cone outer segment tips line
  • Optical coherence tomography
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In context

Lead sponsor

Kyorin University is the lead sponsor of 33 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Thirty-seven eyes of 37 individuals without eye diseases

Inclusion criteria

  • individuals without eye diseases

Exclusion criteria

Exclusion Criteria:

  • individuals with eye diseases
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
37 participants (actual)

Groups and cohorts

  • Normal subjects

    Thirty-seven eyes of 37 individuals without eye diseases

    Other: Optical coherence tomography

Interventions

  • OtherOptical coherence tomography

    Optical coherence tomography

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

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What researchers measure

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.

    Time frame: one year

Secondary outcomes

  1. Visual acuity

    Each subject had a routine eye examination including measuring best-corrected visual acuity (BCVA) and intraocular pressure.

    Time frame: one year

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Study locations

1 site
  • Kyorin Eye Center
    Mitaka, Tokyo 181-8611, Japan
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References and documents

Publications

  • 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. PubMed 22018706 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01316003
Lead sponsor
Kyorin University
Responsible party
Makoto Inoue (Associate professor, Kyorin University) — Principal investigator
First posted
Mar 16, 2011
Start date
Mar 2010
Primary completion
Mar 2011
Completion
Mar 2011
Last update
Aug 2, 2012

Study contacts

Makoto Inoue, MD
principal investigator · Kyorin Eye Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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