GlaucomaNCT02666144
Comparison of Optic Nerve Head and Retinal Nerve Fiber Layer Parameters Derived From Two Different Methods of Scan Alignment
An observational study of Glaucoma, run by Heidelberg Engineering GmbH.
Trial summary
This prospective, monocentric, non-invasive clinical study is designed to measure normal 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, healthy volunteers and glaucoma patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Spectralis OCT
- Type of treatment
- Medical device
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Mar 2016
- 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: 20 eyes of 20 normal healthy subjects and 20 eyes of 20 glaucoma patients, both genders approx. equally.
Who may be able to join
- Able and willing to undergo the test procedures, give consent, and to follow instructions
- Subjects that understand the nature of the trial
- Signed informed consent
- Age : 18 years or older
- For "normal subjects", "normal" means, there is no reason that would prevent imaging of the eye, therefore:
- Self-reported healthy eyes without prior intraocular surgery (except cataract surgery and laser in situ keratomileusis) and without clinically significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve (e.g. impacting central VA or RNFLT measurements as determined by the expertise of the investigator)
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- Visual field GHT within normal limits
- For "glaucoma subjects": Early to advanced glaucoma according to existing medical charts and visual field GHT outside normal limits on at least two occasions during the testing.
- Refraction between +6 and -6 diopters spherical equivalent and astigmatism ≤ 2 diopters
- When both eyes are eligible, one randomly selected eye will be evaluated in the analysis
Who cannot join
- Vulnerable subjects (as defined in ISO 14155 GCP)with the exception of employees of the site, and , if applicable, students of the respective university. Staff that is directly involved in the study is excluded from participation.
- subjects unable to read or write
- 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).
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- 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.
About this study
This prospective, monocentric, non-invasive clinical study is designed to measure normal 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, healthy volunteers and glaucoma patients. The main goal of the study is to provide an analysis of the comparability of these parameters between two different software versions and their respective method of scan centration on the optic disc center. The study will include at least 40 eyes of 40 subjects; 20 normal, healthy subjects and 20 glaucoma patients. All subjects will undergo Spectralis OCT imaging, biometric and ophthalmoscopic examination, and visual field testing in one single visit. Total study duration (first patient first visit to last patient last visit) is anticipated to be approximately 4 weeks.
- Conditions
- Glaucoma
- Being tested
- Spectralis OCT
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectralis OCTDevice
Measurement of structural parameters of the optic nerve head (ONH), in particular, the neuroretinal rim of the ONH, and the peripapillary retinal nerve fiber layer.
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma | Not described Receives: Device: Spectralis OCT | |
| Normal | Not described Receives: Device: Spectralis OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement (Differences) of peripapillary retinal nerve fiber layer thickness
Agreement (Differences) of peripapillary retinal nerve fiber layer thickness in sectors temporal, nasal, nasal superior, nasal inferior, temporal superior and temporal inferior when measured with two different software versions.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg Engineering GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mitchell Dul, OD, Principal investigator, State University of New York College of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666144
- Sponsor's protocol ID
- S-2015-6
- Status last verified
- Apr 2016
- First submitted
- 19 Jan 2016
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Optic Nerve Head and Retinal Nerve Fiber Layer Parameters Derived From Two Different Methods of Scan Alignment
- ClinicalTrials.gov ID
- NCT02666144
- Acronym / sponsor ID
- S-2015-6
- Conditions
- Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Heidelberg Engineering GmbHIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 28 Jan 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.
This prospective, monocentric, non-invasive clinical study is designed to measure normal 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, healthy volunteers and glaucoma patients. The main goal of the study is to provide an analysis of the comparability of these parameters between two different software versions and their respective method of scan centration on the optic disc center. The study will include at least 40 eyes of 40 subjects; 20 normal, healthy subjects and 20 glaucoma patients. All subjects will undergo Spectralis OCT imaging, biometric and ophthalmoscopic examination, and visual field testing in one single visit. Total study duration (first patient first visit to last patient last visit) is anticipated to be approximately 4 weeks.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glaucoma | – | Device: Spectralis OCT |
| Normal | – | Device: Spectralis OCT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 20 eyes of 20 normal healthy subjects and 20 eyes of 20 glaucoma patients, both genders approx. equally.
Key inclusion criteria (10 listed)
- Able and willing to undergo the test procedures, give consent, and to follow instructions
- Subjects that understand the nature of the trial
- Signed informed consent
- Age : 18 years or older
- For "normal subjects", "normal" means, there is no reason that would prevent imaging of the eye, therefore:
Key exclusion criteria (11 listed)
- Vulnerable subjects (as defined in ISO 14155 GCP)with the exception of employees of the site, and , if applicable, students of the respective university. Staff that is directly involved in the study is excluded from participation.
- subjects unable to read or write
- 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.
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 |
|---|---|---|
| Spectralis OCTMeasurement of structural parameters of the optic nerve head (ONH), in particular, the neuroretinal rim of the ONH, and the peripapillary retinal nerve fiber layer. | Device | Glaucoma, Normal |
Primary outcome
Agreement (Differences) of peripapillary retinal nerve fiber layer thickness
Time frame: 4 weeks
Agreement (Differences) of peripapillary retinal nerve fiber layer thickness in sectors temporal, nasal, nasal superior, nasal inferior, temporal superior and temporal inferior when measured with two different software versions.
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 26 Apr 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.
Mitchell Dul, OD principal investigator
State University of New York College of Optometry
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by Heidelberg Engineering GmbH.
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 10 inclusion and 11 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 26 Apr 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?
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?
Agreement (Differences) of peripapillary retinal nerve fiber layer thickness (time frame: 4 weeks). 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 26 Apr 2016.