GlaucomaNCT02785029
Optical Coherence Tomography (OCT) Reference Data Collection Study (S-2015-1)
An observational study of Glaucoma, run by Heidelberg Engineering GmbH at 8 sites in United States.
Trial summary
This prospective, single-arm clinical multicenter study intends 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 African-American descent volunteers. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- OCT
- Type of treatment
- Medical device
- How many people
- 234 participants
- Where
- 8 sitesUnited States
- Study dates
- Jun 2016to Jul 2023
- 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: Healthy eyes without prior intraocular surgery (except cataract surgery and Laser in Situ Keratomileusis) and without clinically significant vitreal, retinal or choroidal diseases, clinically significant diabetic retinopathy (subject may have diabetes), or disease of the optic nerve from subjects of Black or African-American decent (self-reported)
Who may be able to join
- Able and willing to undergo the test procedures, give consent, and to follow instructions.
- Signed informed consent
- Age ≥18 to 90.
- Healthy eye without prior intraocular surgery (except cataract surgery and Laser in Situ Keratomileusis) 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.
- Black or African-American decent (self-reported)
- Negative history of glaucoma (not including family history)
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- Intraocular pressure ≤21mmHg.
- Best corrected visual acuity ≥20/40.
- Refraction between +6 and -6 diopters and astigmatism ≤ 2 diopters.
- Axial length ≤ 26.0 mm (by optical biometry)
- Normal visual field with Glaucoma Hemifield Test and Mean Deviation within normal limits or not abnormal visual field by judgment of the ophthalmologist / optometrist
- 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.
- If both eyes are eligible, both eyes enter the study.
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 listed on the delegation form are 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Illinois Eye Institute, Illinois College of Optometry
Chicago, Illinois, 60616
St Albans Community Living, Center, Queens Campus
Jamaica, New York, 11425
University California San Diego
La Jolla, California, 92093
Mid Florida Eye Center Clinic
Mt. Dora, Florida, 32757
SUNY College of Optometry
New York, New York, 10036
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
Assil Eye Institute
Santa Monica, California, 90404
Ophthalmic Consultants of Long Island-Valley Stream
Valley Stream, New York, 11581
About this study
This prospective, single-arm clinical multicenter study intends 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 African-American descent volunteers. The main goal of the study is to provide the range of these structural parameters in normal eyes.
Read the detailed description
This prospective, single-arm clinical multicenter study intends 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 African-American descent volunteers. The main goal of the study is to provide the range of these structural parameters in normal eyes. The study will include at least 240 normal volunteers; up to 10 study sites will recruit subjects. Overall an approximately equal age distribution from 18 to 90 years and an approximately equal number of females and males will be enrolled (approximately 40-60% females in each age group). All subjects will undergo Spectralis OCT imaging, biometric and ophthalmoscopic examination, disc photography and visual field testing in one single visit, if possible. Repeated perimetry or Spectralis scans may be performed at a second visit within 30 days of the initial visit. All examinations performed on the subjects are non-significant risk procedures.
- Conditions
- Glaucoma
- Being tested
- OCT
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCTDevice
| Study group | Role | What they receive |
|---|---|---|
| Normal healthy Volunteers | OCT imaging Receives: Device: OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bruch-Membrane-Opening - Minimum Rim Width (µm)
Bruch-Membrane-Opening - Minimum Rim Width (µm)
Measured: Baseline
Bruch-Membrane-Opening - Minimum Rim Area (µm^2)
Bruch-Membrane-Opening - Minimum Rim Area (µm^2)
Measured: Baseline
Peripapillary Retinal Nerve Fibre Layer Thickness (µm)
Peripapillary Retinal Nerve Fibre Layer Thickness (µm)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startJun 2016
- Primary completionMay 2023
- Study completionJul 2023
Why it stopped: difficulty in recruiting older subjects
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg Engineering GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Balwantray Chauhan, OD, Principal investigator, Department of Ophthalmology and Visual Sciences Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785029
- Sponsor's protocol ID
- S-2015-1-aa
- Status last verified
- Aug 2023
- First submitted
- 18 May 2016
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography (OCT) Reference Data Collection Study (S-2015-1)
- ClinicalTrials.gov ID
- NCT02785029
- Acronym / sponsor ID
- S-2015-1-aa
- Conditions
- Glaucoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: difficulty in recruiting older subjects
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Heidelberg Engineering GmbHIndustry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- May 2023 (actual)
- Study completion
- Jul 2023 (actual)
- First posted
- 27 May 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, single-arm clinical multicenter study intends 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 African-American descent volunteers. The main goal of the study is to provide the range of these structural parameters in normal eyes.
Detailed description
This prospective, single-arm clinical multicenter study intends 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 African-American descent volunteers. The main goal of the study is to provide the range of these structural parameters in normal eyes. The study will include at least 240 normal volunteers; up to 10 study sites will recruit subjects. Overall an approximately equal age distribution from 18 to 90 years and an approximately equal number of females and males will be enrolled (approximately 40-60% females in each age group). All subjects will undergo Spectralis OCT imaging, biometric and ophthalmoscopic examination, disc photography and visual field testing in one single visit, if possible. Repeated perimetry or Spectralis scans may be performed at a second visit within 30 days of the initial visit. All examinations performed on the subjects are non-significant risk procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal healthy Volunteers | – | Device: OCTOCT imaging |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy eyes without prior intraocular surgery (except cataract surgery and Laser in Situ Keratomileusis) and without clinically significant vitreal, retinal or choroidal diseases, clinically significant diabetic retinopathy (subject may have diabetes), or disease of the optic nerve from subjects of Black or African-American decent (self-reported)
Key inclusion criteria (13 listed)
- Able and willing to undergo the test procedures, give consent, and to follow instructions.
- Signed informed consent
- Age ≥18 to 90.
- Healthy eye without prior intraocular surgery (except cataract surgery and Laser in Situ Keratomileusis) 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.
- Black or African-American decent (self-reported)
Key exclusion criteria (10 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 listed on the delegation form are 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 |
|---|---|---|
| OCT | Device | Normal healthy Volunteers |
Primary outcome
Bruch-Membrane-Opening - Minimum Rim Width (µm)
Time frame: Baseline
Bruch-Membrane-Opening - Minimum Rim Width (µm)
Bruch-Membrane-Opening - Minimum Rim Area (µm^2)
Time frame: Baseline
Bruch-Membrane-Opening - Minimum Rim Area (µm^2)
Peripapillary Retinal Nerve Fibre Layer Thickness (µm)
Time frame: Baseline
Peripapillary Retinal Nerve Fibre Layer Thickness (µm)
Results and safety
The study was stopped early (reason given: difficulty in recruiting older subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Balwantray Chauhan, OD principal investigator
Department of Ophthalmology and Visual Sciences Dalhousie University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by Heidelberg Engineering GmbH at 8 sites 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 13 inclusion and 10 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: stopped early, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 was stopped early (reason given: difficulty in recruiting older subjects). 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?
Bruch-Membrane-Opening - Minimum Rim Width (µm) (time frame: Baseline). The study lists 3 primary outcomes in all. 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 19 Mar 2025.