Spectralis OCT Repeatability and Reproducibility Study

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology and Visual Sciences, Dalhousie University

Halifax, Nova Scotia, B3H 2Y9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OCT performed to collect data from the back of the eye

Device

comparative retinal parameters with Spectralis OCT

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Heidelberg Engineering GmbH

Industry

Registry information

Official study title

Repeatability and Reproducibility of Optic Nerve Head (ONH), Retinal Nerve Fiber Layer (RNFL), and Macula Parameters With the Heidelberg Spectralis OCT.

Acronym: S-2013-1

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Aug 5, 2014
Registry last updated: Aug 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed