Back to resultsSpectralis OCT Repeatability and Reproducibility Study (S-2013-1)
Primary Purpose
Glaucoma
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
OCT performed to collect data from the back of the eye
Sponsored by
About this trial
This is an interventional diagnostic trial for Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Subject is not an employee of the eye clinic.
- Age ≥18
- Able and willing to undergo the test procedures, give consent, and to follow instructions.
- For "normal subjects": Healthy eye without prior intraocular surgery (except cataract surgery and Lasik - laser-assisted refractive surgery) and without clinically significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve.
- For "glaucoma subjects": Early to advanced glaucoma according to existing medical charts.
- Refraction between +6 and -6 diopters and astigmatism ≤ 2 diopters.
- When both eyes are eligible, one randomly selected eye will enter the study.
Exclusion Criteria:
• 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
Sites / Locations
- Department of Ophthalmology and Visual Sciences, Dalhousie University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Healthy Volunteers
Glaucoma group
Arm Description
OCT performed to collect data from the back of the eye
OCT performed to collect data from the back of the eye
Outcomes
Primary Outcome Measures
Reproducibility and repeatability of multiple parameters (measured with OCT in the back of the eye) between different studies and different subject types
This study is designed to determine optic nerve head structural values such as ONH rim thickness, RNFL thickness values, and macula structural values such as total retinal or ganglion cell layer thickness, as measured using the Spectralis device in a population of either subjects that are determined to be clinically "normal" or "glaucomatous". The expected reproducibility and repeatability are approximately 5% or less of the respective means (coefficients of variation, cov). This study shall result in a 95% confidence interval of the cov estimate not larger than ±1% when all data is pooled (normal and glaucoma cases). Statistical analysis of the measurement values will consist of the computation of mean and standard deviation in repeated examinations with the SPECTRALIS OCT in the normal and glaucomatous population.
Secondary Outcome Measures
Full Information
NCT ID
NCT02209077
First Posted
August 12, 2013
Last Updated
August 1, 2014
Sponsor
Heidelberg Engineering GmbH
1. Study Identification
Unique Protocol Identification Number
NCT02209077
Brief Title
Spectralis OCT Repeatability and Reproducibility Study
Acronym
S-2013-1
Official Title
Repeatability and Reproducibility of Optic Nerve Head (ONH), Retinal Nerve Fiber Layer (RNFL), and Macula Parameters With the Heidelberg Spectralis OCT.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heidelberg Engineering GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This single-center, prospective, interventional clinical study is conducted to evaluate the repeatability and reproducibility of structural parameters of the optic nerve head, the peripapillary retinal nerve fiber layer, and the macula using the Heidelberg Spectralis OCT (Optical Coherence Tomography) device. Data obtained from healthy volunteers in this study are compared to those from a previous, larger healthy volunteer study that was conducted in the United States and Europe (S-2012-1), and data from glaucoma patients are compared to those from the healthy volunteers.
Detailed Description
The study will include approximately 15 normal subjects and approximately 15 subjects who have glaucoma of varying degree. All subjects will undergo Spectralis OCT imaging and other study procedures 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 is anticipated to not exceed 4 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy Volunteers
Arm Type
Experimental
Arm Description
OCT performed to collect data from the back of the eye
Arm Title
Glaucoma group
Arm Type
Experimental
Arm Description
OCT performed to collect data from the back of the eye
Intervention Type
Device
Intervention Name(s)
OCT performed to collect data from the back of the eye
Intervention Description
comparative retinal parameters with Spectralis OCT
Primary Outcome Measure Information:
Title
Reproducibility and repeatability of multiple parameters (measured with OCT in the back of the eye) between different studies and different subject types
Description
This study is designed to determine optic nerve head structural values such as ONH rim thickness, RNFL thickness values, and macula structural values such as total retinal or ganglion cell layer thickness, as measured using the Spectralis device in a population of either subjects that are determined to be clinically "normal" or "glaucomatous". The expected reproducibility and repeatability are approximately 5% or less of the respective means (coefficients of variation, cov). This study shall result in a 95% confidence interval of the cov estimate not larger than ±1% when all data is pooled (normal and glaucoma cases). Statistical analysis of the measurement values will consist of the computation of mean and standard deviation in repeated examinations with the SPECTRALIS OCT in the normal and glaucomatous population.
Time Frame
one day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject is not an employee of the eye clinic.
Age ≥18
Able and willing to undergo the test procedures, give consent, and to follow instructions.
For "normal subjects": Healthy eye without prior intraocular surgery (except cataract surgery and Lasik - laser-assisted refractive surgery) and without clinically significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve.
For "glaucoma subjects": Early to advanced glaucoma according to existing medical charts.
Refraction between +6 and -6 diopters and astigmatism ≤ 2 diopters.
When both eyes are eligible, one randomly selected eye will enter the study.
Exclusion Criteria:
• 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Balwantray C Chauhan, PhD
Organizational Affiliation
Department of Ophthalmology and Visual Sciences, Dalhousie University, Halifax, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology and Visual Sciences, Dalhousie University
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
12. IPD Sharing Statement
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Spectralis OCT Repeatability and Reproducibility Study
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