Optical TomographyNCT01115881
Relationship Between Macular Thickness Measurement and Signal Strength in Optical Coherence Tomography
An observational study of Optical Tomography, run by Meir Medical Center at 1 site in Israel.
Trial summary
Signal strength is a parameter introduced in analysis software version 4.0.1, of the OCT stratus, that combines SNR and uniformity of the signal within a scan The scale of signal strength ranges from 1 to 10, with 1 representing poor image quality and 10 representing excellent image quality It has been showed that… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Optical Tomography
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- May 2010to May 2013
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy
Who may be able to join
- healthy subjects in this study other than refractive error, all included eyes had no concurrent ocular pathologic features BCVA of at least 20/30, and had spherical refractive error within the range of
- 4.00 D to 4.00 D
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Macular Thickness Measurement and Signal Strength Using Stratus Optical Coherence Tomography
Signal strength is a parameter introduced in analysis software version 4.0.1, of the OCT stratus, that combines SNR and uniformity of the signal within a scan The scale of signal strength ranges from 1 to 10, with 1 representing poor image quality and 10 representing excellent image quality It has been showed that signal strength has a better image quality discriminating ability than SNR The operation manual recommends a minimum signal strength of 5 for macular thickness measurement There is no consensus on the level of signal strength above which should be considered to be good quality The inclusion Criteria for acceptable signal strength varies widely in the literature the purpose of our study is to examine the relationship between signal strength and macular thickness measured by stratus OCT
- Conditions
- Optical Tomography
- Keywords
- To examine the relationship between signal strength and macular thickness measured by stratus OCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optical TomographyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ori Segal, M.D, Principal investigator, Sackler school of medicine Tel-Aviv university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115881
- Sponsor's protocol ID
- OCT-1
- Status last verified
- Jan 2010
- First submitted
- 2 May 2010
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Macular Thickness Measurement and Signal Strength Using Stratus Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT01115881
- Acronym / sponsor ID
- OCT-1
- Conditions
- Optical Tomography
- Keywords
- To examine the relationship between signal strength and macular thickness measured by stratus OCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 4 May 2010 (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.
Signal strength is a parameter introduced in analysis software version 4.0.1, of the OCT stratus, that combines SNR and uniformity of the signal within a scan The scale of signal strength ranges from 1 to 10, with 1 representing poor image quality and 10 representing excellent image quality It has been showed that signal strength has a better image quality discriminating ability than SNR The operation manual recommends a minimum signal strength of 5 for macular thickness measurement There is no consensus on the level of signal strength above which should be considered to be good quality The inclusion Criteria for acceptable signal strength varies widely in the literature the purpose of our study is to examine the relationship between signal strength and macular thickness measured by stratus OCT
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy
Key inclusion criteria (2 listed)
- healthy subjects in this study other than refractive error, all included eyes had no concurrent ocular pathologic features BCVA of at least 20/30, and had spherical refractive error within the range of
- 4.00 D to 4.00 D
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 27 Sep 2016.
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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.
Ori Segal, M.D principal investigator
Sackler school of medicine Tel-Aviv university
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 Optical Tomography, run by Meir Medical Center at 1 site in Israel.
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 2 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 27 Sep 2016. 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 Israel. 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.
Where can I read the original study information?
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 27 Sep 2016.