HealthyS-2013-3NCT02014688
Optical Coherence Tomography (OCT) Normative Data Collection Study
An observational study of Healthy, run by Heidelberg Engineering GmbH at 1 site in United States.
Trial summary
This study is being initiated to create a normal database including measures of optic nerve head (ONH), peripapillary retinal nerve fiber layer (RNFL), and macula using the Heidelberg Spectralis OCT device. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Oct 2014
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Recruitment will be from persons who respond to recruitment initiatives at the individual centers or have signed a release saying that they are willing to be approached for participation in research. At least 87 subjects (enrollment target: 135 subjects) will be selected from qualifying normal volunteers. Age range will be from ≥18 to 90 years. The age of the subjects will be defined by their month of birth versus the month of giving consent to participate in this study. A subject who is 40 years and 11 months old will be counted as being in the age group "31 to 40 years". Each site will attempt to recruit subjects in about equal numbers in each age group. The distribution in the age groups should be fairly equal among subjects in each ethnic group alone.
Who may be able to join
- Subject is not an employee of the eye clinic.
- Age ≥18 to 90.
- Able and willing to undergo the test procedures, give consent, and to follow instructions.
- Healthy eye without prior intraocular surgery (except cataract surgery) and without clinically significant vitreal, retinal or choroidal diseases, clinically significant diabetic retinopathy (subject may have diabetes), or disease of the optic nerve. Small Drusen are acceptable in older subjects.
- Hispanic Descent, Black or African American Descent, Asian Descent, American Indian or Alaskan Native Descent
- Negative history of glaucoma.
Show all 12Show fewer
- Intraocular pressure ≤21mmHg.
- Best corrected visual acuity ≥0.5.
- Refraction between +6 and -6 diopters and astigmatism ≤ 2 diopters.
- Normal visual field with Glaucoma Hemifield Test and Mean Deviation within normal limits, or not abnormal visual field by judgment of the ophthalmologist.
- Clinically normal appearance of the optic disc, with normal appearing neuroretinal rim with respect to color and shape. The optic disc is examined ophthalmoscopically and by evaluation of stereo photographs.
- When both eyes are eligible, both eyes enter the study.
Who cannot join
- Unreliable visual field. The reliability indices should be used as guide as well as the perimetrist's notes.
- Unusable disc stereo photos.
- Inability to undergo the tests.
- Insufficient quality of Spectralis OCT images (this is not determined until after Spectralis OCT examination, and is an unusual circumstance). Minimum requirements are:
- Retina completely included in image frame,
- Quality Score ≥ 20 in the stored ART mean images, and
- For ONH-R scan: Center position error ≤ 100 μm.
- Note: Inability of a subject to perform one of the two scan patterns or insufficient image quality in one scan pattern does not exclude the subject or eye from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Eye and Ear Infirmary
New York, New York, 10003-4297
About this study
Official title: Multi-center Study for Normal Database of Optic Nerve Head, Retinal Nerve Fiber Layer, and Macula Parameters With the Heidelberg Spectralis OCT, Study 3
This study is being initiated to create a normal database including measures of optic nerve head (ONH), peripapillary retinal nerve fiber layer (RNFL), and macula using the Heidelberg Spectralis OCT device.
Read the detailed description
This multi-center, prospective, observational (non-interventional) study is the third in a series to measure structural parameters of the optic nerve head, the peripapillary retinal nerve fiber layer, and the macula using the Heidelberg Spectralis OCT device. This study is conducted in normal volunteers of various non-Caucasian ethnic group, and data will be combined with Caucasian subjects to be representative of the US population: (1) Hispanic Descent, (2) Black or African American Descent, (3) Asian Descent, (4) American Indian or Alaskan Native Descent. This study will complement the previous study S-2012-1 NORM-cc, in which normal data from Caucasian individuals were collected.
The main goal of the study is to provide the range of these structural parameters in normal eyes. The study will include at least 87 (enrollment target: 135) normal volunteers; each study site will recruit at least 29 (target: 45) subjects with an age range of 18 to 90 years and an approximately equal number of females and males. All subjects will undergo Spectralis OCT imaging, biometric and ophthalmoscopic examination, disc photography and visual field testing in one single visit. All examinations performed on the subjects are non-significant risk procedures because the medical devices are cleared for marketing in Europe and in the U.S. Total study duration including IRB approval is anticipated to not exceed 4 months.
- Conditions
- Healthy
- Keywords
- Normal subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| American Indian or Alaskan Native Descent | Not described | |
| Black or African American Descent | Not described | |
| Asian Descent | Not described | |
| Hispanic Descent | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normative Data for optic nerve head, the peripapillary retinal nerve fiber layer, and the macula.
This normal database will be used to determine if an unknown subject has measurement values "within normal limits" or "outside normal limits." It is planned to classify an eye "within normal limits" if the measurement value is greater than or equal to the 5th percentile of the normal distribution (or less than or equal to the 95th percentile), and as "outside normal limits" if the measurement value is smaller than the 1st percentile (or larger than 99th percentile) of the normal distribution. Thus, the sample size must be large enough to ensure that the 1st and the 5th percentiles of the distribution are distinct.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg Engineering GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Liebman, MD, Principal investigator, Manhattan Eye, Ear and Throat Hospital and New York University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014688
- Sponsor's protocol ID
- S-2013-3 NORM-us
- Acronym
- S-2013-3
- Status last verified
- Aug 2015
- First submitted
- 11 Dec 2013
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Study for Normal Database of Optic Nerve Head, Retinal Nerve Fiber Layer, and Macula Parameters With the Heidelberg Spectralis OCT, Study 3
- ClinicalTrials.gov ID
- NCT02014688
- Acronym / sponsor ID
- S-2013-3 / S-2013-3 NORM-us
- Conditions
- Healthy
- Keywords
- Normal subjects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Heidelberg Engineering GmbHIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 18 Dec 2013 (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.
This study is being initiated to create a normal database including measures of optic nerve head (ONH), peripapillary retinal nerve fiber layer (RNFL), and macula using the Heidelberg Spectralis OCT device.
Detailed description
This multi-center, prospective, observational (non-interventional) study is the third in a series to measure structural parameters of the optic nerve head, the peripapillary retinal nerve fiber layer, and the macula using the Heidelberg Spectralis OCT device. This study is conducted in normal volunteers of various non-Caucasian ethnic group, and data will be combined with Caucasian subjects to be representative of the US population: (1) Hispanic Descent, (2) Black or African American Descent, (3) Asian Descent, (4) American Indian or Alaskan Native Descent. This study will complement the previous study S-2012-1 NORM-cc, in which normal data from Caucasian individuals were collected.
The main goal of the study is to provide the range of these structural parameters in normal eyes. The study will include at least 87 (enrollment target: 135) normal volunteers; each study site will recruit at least 29 (target: 45) subjects with an age range of 18 to 90 years and an approximately equal number of females and males. All subjects will undergo Spectralis OCT imaging, biometric and ophthalmoscopic examination, disc photography and visual field testing in one single visit. All examinations performed on the subjects are non-significant risk procedures because the medical devices are cleared for marketing in Europe and in the U.S. Total study duration including IRB approval is anticipated to not exceed 4 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| American Indian or Alaskan Native Descent | – | – |
| Black or African American Descent | – | – |
| Asian Descent | – | – |
| Hispanic Descent | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Recruitment will be from persons who respond to recruitment initiatives at the individual centers or have signed a release saying that they are willing to be approached for participation in research. At least 87 subjects (enrollment target: 135 subjects) will be selected from qualifying normal volunteers. Age range will be from ≥18 to 90 years. The age of the subjects will be defined by their month of birth versus the month of giving consent to participate in this study. A subject who is 40 years and 11 months old will be counted as being in the age group "31 to 40 years". Each site will attempt to recruit subjects in about equal numbers in each age group. The distribution in the age groups should be fairly equal among subjects in each ethnic group alone.
Key inclusion criteria (12 listed)
- Subject is not an employee of the eye clinic.
- Age ≥18 to 90.
- Able and willing to undergo the test procedures, give consent, and to follow instructions.
- Healthy eye without prior intraocular surgery (except cataract surgery) and without clinically significant vitreal, retinal or choroidal diseases, clinically significant diabetic retinopathy (subject may have diabetes), or disease of the optic nerve. Small Drusen are acceptable in older subjects.
- Hispanic Descent, Black or African American Descent, Asian Descent, American Indian or Alaskan Native Descent
Key exclusion criteria (8 listed)
- Unreliable visual field. The reliability indices should be used as guide as well as the perimetrist's notes.
- Unusable disc stereo photos.
- Inability to undergo the tests.
- Insufficient quality of Spectralis OCT images (this is not determined until after Spectralis OCT examination, and is an unusual circumstance). Minimum requirements are:
- Note: Inability of a subject to perform one of the two scan patterns or insufficient image quality in one scan pattern does not exclude the subject or eye from the study.
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
Normative Data for optic nerve head, the peripapillary retinal nerve fiber layer, and the macula.
Time frame: 12 months
This normal database will be used to determine if an unknown subject has measurement values "within normal limits" or "outside normal limits." It is planned to classify an eye "within normal limits" if the measurement value is greater than or equal to the 5th percentile of the normal distribution (or less than or equal to the 95th percentile), and as "outside normal limits" if the measurement value is smaller than the 1st percentile (or larger than 99th percentile) of the normal distribution. Thus, the sample size must be large enough to ensure that the 1st and the 5th percentiles of the distribution are distinct.
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 20 Aug 2015.
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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.
Jeffrey Liebman, MD principal investigator
Manhattan Eye, Ear and Throat Hospital and New York University Medical 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 Heidelberg Engineering GmbH at 1 site in United States.
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 12 inclusion and 8 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 20 Aug 2015. 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 United States. 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?
Normative Data for optic nerve head, the peripapillary retinal nerve fiber layer, and the macula. (time frame: 12 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 20 Aug 2015.