Spectralis OCT Repeatability and Reproducibility Study

NCT02209077 | Completed

• 1 other identifier: S-2013-1 Study (REPRO)
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• 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.

  one day

Study Arms (2)

Healthy Volunteers

EXPERIMENTAL

OCT performed to collect data from the back of the eye

Device: OCT performed to collect data from the back of the eye

Glaucoma group

EXPERIMENTAL

OCT performed to collect data from the back of the eye

Device: OCT performed to collect data from the back of the eye

Interventions

OCT performed to collect data from the back of the eye DEVICE

comparative retinal parameters with Spectralis OCT

Glaucoma group; Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg Engineering GmbH: lead

Study Sites (1)

Department of Ophthalmology and Visual Sciences, Dalhousie University

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Balwantray C Chauhan, PhD

  Department of Ophthalmology and Visual Sciences, Dalhousie University, Halifax, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2013
• First Posted: August 5, 2014
• Study Start: June 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 5, 2014

Record last verified: 2014-08

Locations

CA (1)