HealthyNCT01316003
Distinction of Cone Outer Segment Tips by Spectral-Domain Optical Coherence Tomography in Normal Eyes
An observational study of Healthy, run by Kyorin University at 1 site in Japan.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Optical coherence tomography
- How many people
- 37 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2010to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Thirty-seven eyes of 37 individuals without eye diseases
Who may be able to join
- individuals without eye diseases
Who cannot join
- individuals with eye diseases
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healthy
- Being tested
- Optical coherence tomography
- Keywords
- cone outer segment tips line, Optical coherence tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomographyOther
Also called Cirrus HD-OCT (Carl Zeiss Meditec)
Optical coherence tomography
| Study group | Role | What they receive |
|---|---|---|
| Normal subjects | Thirty-seven eyes of 37 individuals without eye diseases Receives: Other: Optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (1)
Visual acuity
Each subject had a routine eye examination including measuring best-corrected visual acuity (BCVA) and intraocular pressure.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study startMar 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyorin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Makoto Inoue, Kyorin University
- Investigators
- Makoto Inoue, MD, Principal investigator, Kyorin Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01316003
- Sponsor's protocol ID
- KyorinEye004
- Status last verified
- Jul 2012
- First submitted
- 15 Mar 2011
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distinction of Cone Outer Segment Tips by Spectral-Domain Optical Coherence Tomography in Normal Eyes
- ClinicalTrials.gov ID
- NCT01316003
- Acronym / sponsor ID
- KyorinEye004
- Conditions
- Healthy
- Keywords
- cone outer segment tips line, Optical coherence tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Kyorin UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 16 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal subjects | – | Other: Optical coherence tomographyThirty-seven eyes of 37 individuals without eye diseases |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Thirty-seven eyes of 37 individuals without eye diseases
Key inclusion criteria (1 listed)
- individuals without eye diseases
Key exclusion criteria (1 listed)
- individuals with eye diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical coherence tomographyAlso: Cirrus HD-OCT (Carl Zeiss Meditec)Optical coherence tomography | Other | Normal subjects |
Primary outcome
Microstructural analysis by Spectral domain optical coherence tomography
Time frame: one year
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.
1 secondary outcome
Visual acuity
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2012.
- Derived from this study: PubMed 22018706Rii 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Makoto Inoue, MD principal investigator
Kyorin Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Kyorin University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microstructural analysis by Spectral domain optical coherence tomography (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01316003, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2012.