Spectralis OCT Repeatability and Reproducibility Study (S-2013-1)

• ClinicalTrials.gov Identifier: NCT02209077
• Recruitment Status: Completed
• First Posted: August 5, 2014
• Last Update Posted: August 5, 2014
• Sponsor: Heidelberg Engineering GmbH
• Information provided by (Responsible Party): Heidelberg Engineering GmbH

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.

Condition or disease	Intervention/treatment	Phase
Glaucoma	Device: OCT performed to collect data from the back of the eye	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Repeatability and Reproducibility of Optic Nerve Head (ONH), Retinal Nerve Fiber Layer (RNFL), and Macula Parameters With the Heidelberg Spectralis OCT.
• Study Start Date: June 2013
• Actual Primary Completion Date: July 2013
• Actual Study Completion Date: July 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Healthy Volunteers; OCT performed to collect data from the back of the eye	Device: OCT performed to collect data from the back of the eye; comparative retinal parameters with Spectralis OCT
Experimental: Glaucoma group; OCT performed to collect data from the back of the eye	Device: OCT performed to collect data from the back of the eye; comparative retinal parameters with Spectralis OCT

Outcome Measures

Primary Outcome Measures :

1. Reproducibility and repeatability of multiple parameters (measured with OCT in the back of the eye) between different studies and different subject types [ Time Frame: one day ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Canada, Nova Scotia

Department of Ophthalmology and Visual Sciences, Dalhousie University

Halifax, Nova Scotia, Canada, B3H 2Y9

Sponsors and Collaborators

Heidelberg Engineering GmbH

Investigators

• Principal Investigator: Balwantray C Chauhan, PhD; Department of Ophthalmology and Visual Sciences, Dalhousie University, Halifax, Canada

More Information

• Responsible Party: Heidelberg Engineering GmbH
• ClinicalTrials.gov Identifier: NCT02209077
• Other Study ID Numbers: S-2013-1 Study (REPRO)
• First Posted: August 5, 2014
• Last Update Posted: August 5, 2014
• Last Verified: August 2014

Additional relevant MeSH terms:

Glaucoma; Ocular Hypertension; Eye Diseases