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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Makoto Inoue, Kyorin University
ClinicalTrials.gov Identifier:
NCT01316003
First received: March 15, 2011
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Healthy
Other: Optical coherence tomography

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Distinction of Cone Outer Segment Tips by Spectral-Domain Optical Coherence Tomography in Normal Eyes

Further study details as provided by Kyorin University:

Primary Outcome Measures:
  • Microstructural analysis by Spectral domain optical coherence tomography [ Time Frame: one year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Visual acuity [ Time Frame: one year ] [ Designated as safety issue: No ]
    Each subject had a routine eye examination including measuring best-corrected visual acuity (BCVA) and intraocular pressure.


Enrollment: 37
Study Start Date: March 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Normal subjects
Thirty-seven eyes of 37 individuals without eye diseases
Other: Optical coherence tomography
Optical coherence tomography
Other Name: Cirrus HD-OCT (Carl Zeiss Meditec)

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Thirty-seven eyes of 37 individuals without eye diseases

Criteria

Inclusion Criteria:

  • individuals without eye diseases

Exclusion Criteria:

  • individuals with eye diseases
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01316003

Locations
Japan
Kyorin Eye Center
Mitaka, Tokyo, Japan, 181-8611
Sponsors and Collaborators
Kyorin University
Investigators
Principal Investigator: Makoto Inoue, MD Kyorin Eye Center
  More Information

No publications provided by Kyorin University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Makoto Inoue, Associate professor, Kyorin University
ClinicalTrials.gov Identifier: NCT01316003     History of Changes
Other Study ID Numbers: KyorinEye004
Study First Received: March 15, 2011
Last Updated: July 31, 2012
Health Authority: Japan: Institutional Review Board

Keywords provided by Kyorin University:
cone outer segment tips line
Optical coherence tomography

ClinicalTrials.gov processed this record on September 18, 2014