GlaucomaNCT01641835
Optical Coherence Tomography (OCT) Data Collection Study
An observational study of Glaucoma, run by Heidelberg Engineering GmbH at 1 site in Canada.
Trial summary
Collect OCT data to evaluate the range and age trend of ocular measurements. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- How many people
- 303 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2012to Dec 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: No eye disease.
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 Lasik) and without clinically significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve.
- Caucasian decent (self-reported).
- 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.
- 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 for inter-eye asymmetry; one randomly selected eye will be used for all other measures.
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.
About this study
Official title: Optical Coherence Tomography (OCT) Data Collection Study "S-2012-1 Norm-cc"
Collect OCT data to evaluate the range and age trend of ocular measurements.
Read the detailed description
This is a prospective, multi-center study. Ocular history and examination will be conducted on consented subjects to determine further participation in the study. Subjects qualified to continue will undergo imaging of both eyes using the SPECTRALIS OCT.
- Conditions
- Glaucoma
- Medical subject headings
- Glaucoma
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 |
|---|---|---|
| Normals | No eye disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoints
The primary endpoints are the structural measurement values of (1) the ONH, (2) the peri-papillary RNFL, and (3) the macula obtained using the Spectralis OCT and the statistical descriptors such as mean, standard deviation, and distribution percentiles.
Measured: 3 months
Bruch's Membrane Opening - Minimum Rim Area, Global
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg Engineering GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Balwantray Chauhan, PhD, Principal investigator, Dalhousie University, Halifax, NS, CanadaClaude Burgoyne, MD, Principal investigator, Devers Eye Institute, Portland, OR, USAChristopher Girkin, MD, Principal investigator, Callahan Eye Foundation Hospital, Birmingham, AL, USAChristian Mardin, MD, Principal investigator, Augenklinik des Universitätsklinikums Erlangen, Erlangen, GermanyAlexander Scheuerle, MD, Principal investigator, Universitätsaugenklinik, Heidelberg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641835
- Sponsor's protocol ID
- S-2012-1 NORM-cc
- Status last verified
- Sep 2016
- First submitted
- 13 Jul 2012
- Last updated
- 19 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography (OCT) Data Collection Study "S-2012-1 Norm-cc"
- ClinicalTrials.gov ID
- NCT01641835
- Acronym / sponsor ID
- S-2012-1 NORM-cc
- Conditions
- Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Heidelberg Engineering GmbHIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 17 Jul 2012 (estimated)
- Results
- Posted 19 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Collect OCT data to evaluate the range and age trend of ocular measurements.
Detailed description
This is a prospective, multi-center study. Ocular history and examination will be conducted on consented subjects to determine further participation in the study. Subjects qualified to continue will undergo imaging of both eyes using the SPECTRALIS OCT.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normals | – | –No eye disease. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- No eye disease.
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 Lasik) and without clinically significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve.
- Caucasian decent (self-reported).
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
Primary Endpoints
Time frame: 3 months
The primary endpoints are the structural measurement values of (1) the ONH, (2) the peri-papillary RNFL, and (3) the macula obtained using the Spectralis OCT and the statistical descriptors such as mean, standard deviation, and distribution percentiles.
Bruch's Membrane Opening - Minimum Rim Area, Global
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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, PhD principal investigator
Dalhousie University, Halifax, NS, Canada
Claude Burgoyne, MD principal investigator
Devers Eye Institute, Portland, OR, USA
Christopher Girkin, MD principal investigator
Callahan Eye Foundation Hospital, Birmingham, AL, USA
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 Glaucoma, run by Heidelberg Engineering GmbH at 1 site in Canada.
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 19 Dec 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 Canada. 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?
Yes. Results are posted in the registry (first posted 19 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Primary Endpoints (time frame: 3 months). The study lists 2 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 Dec 2016.