Nerve Fiber Bundle DefectNCT02700750
Relation Between Macular and RNFL Thickness Measurement and Quality Grading in OCT
A study testing OCT exam in people with Nerve Fiber Bundle Defect, run by Meir Medical Center.
Trial summary
The investigators will enroll and scan normal eyes of healthy individuals using the Spectralis OCT. Each scan is graded on a scale of 0-40, with 0 representing the lowest quality and 40 the best possible one. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nerve Fiber Bundle Defect
- What is being tested?
- OCT exam
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Mar 2017
- Phase
- Interventional
- 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
Who may be able to join
None listed.
Who cannot join
- Any history or evidence of eye disease or surgery.
- Intraocular pressure (IOP) more than 22 mm Hg.
About this study
The investigators will enroll and scan normal eyes of healthy individuals using the Spectralis OCT. Each scan is graded on a scale of 0-40, with 0 representing the lowest quality and 40 the best possible one. Each of the participants will be scanned numerous times using this noninvasive imaging tool, while trying to get as many scans as possible of different quality. The differences in the parameters between the scans will then be recoded.
Collected data will include age, sex, subjects' refractive status, visual acuity, full slit lamp exam and the participants' OCT characteristics and measurements.
Read the detailed description
The investigators will enroll and scan 200 normal eyes of 100 healthy individuals using the Spectralis OCT. Each scan is graded on a scale of 0-40, with 0 representing the lowest quality and 40 the best possible one. Each of the subjects will be scanned numerous times using this noninvasive imaging tool, while trying to get as many scans as possible of different quality. The differences in the parameters between the scans will then be recoded.
Collected data will include age, sex, subjects' refractive status, visual acuity, full slit lamp exam and the participants' OCT characteristics and measurements.
- Conditions
- Nerve Fiber Bundle Defect
- Being tested
- OCT exam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT examDevice
OCT exam
| Study group | Role | What they receive |
|---|---|---|
| OCT exam | Other | OCT exam No Arm No Intervention Receives: Device: OCT exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between quality grading and retinal and RNFL thickness
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve Fiber Bundle DefectStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ori Segal, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700750
- Sponsor's protocol ID
- 294-15
- Status last verified
- Mar 2016
- First submitted
- 21 Feb 2016
- Last updated
- 7 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Macular and RNFL Thickness Measurement and Quality Grading in OCT
- ClinicalTrials.gov ID
- NCT02700750
- Acronym / sponsor ID
- 294-15
- Conditions
- Nerve Fiber Bundle Defect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 7 Mar 2016 (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 investigators will enroll and scan normal eyes of healthy individuals using the Spectralis OCT. Each scan is graded on a scale of 0-40, with 0 representing the lowest quality and 40 the best possible one. Each of the participants will be scanned numerous times using this noninvasive imaging tool, while trying to get as many scans as possible of different quality. The differences in the parameters between the scans will then be recoded.
Collected data will include age, sex, subjects' refractive status, visual acuity, full slit lamp exam and the participants' OCT characteristics and measurements.
Detailed description
The investigators will enroll and scan 200 normal eyes of 100 healthy individuals using the Spectralis OCT. Each scan is graded on a scale of 0-40, with 0 representing the lowest quality and 40 the best possible one. Each of the subjects will be scanned numerous times using this noninvasive imaging tool, while trying to get as many scans as possible of different quality. The differences in the parameters between the scans will then be recoded.
Collected data will include age, sex, subjects' refractive status, visual acuity, full slit lamp exam and the participants' OCT characteristics and measurements.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OCT exam | Other | Device: OCT examOCT exam No Arm No Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Any history or evidence of eye disease or surgery.
- Intraocular pressure (IOP) more than 22 mm Hg.
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 |
|---|---|---|
| OCT examOCT exam | Device | OCT exam |
Primary outcome
correlation between quality grading and retinal and RNFL thickness
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2016.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing OCT exam in people with Nerve Fiber Bundle Defect, run by Meir Medical Center.
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 0 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
correlation between quality grading and retinal and RNFL thickness (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
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 7 Mar 2016.