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Comparison of Optic Nerve Head and Retinal Nerve Fiber Layer Parameters Derived From Two Different Methods of Scan Alignment

NCT02666144 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 48

Last updated 2016-04-26

No results posted yet for this study

Summary

This prospective, monocentric, non-invasive clinical study is designed to measure normal structural parameters of the optic nerve head, the peripapillary retinal nerve fiber layer, and the macula using the Heidelberg Spectralis OCT device. This study is conducted in normal, healthy volunteers and glaucoma patients. The main goal of the study is to provide an analysis of the comparability of these parameters between two different software versions and their respective method of scan centration on the optic disc center. The study will include at least 40 eyes of 40 subjects; 20 normal, healthy subjects and 20 glaucoma patients. All subjects will undergo Spectralis OCT imaging, biometric and ophthalmoscopic examination, and visual field testing in one single visit. Total study duration (first patient first visit to last patient last visit) is anticipated to be approximately 4 weeks.

Conditions

Interventions

DEVICE

Spectralis OCT

Measurement of structural parameters of the optic nerve head (ONH), in particular, the neuroretinal rim of the ONH, and the peripapillary retinal nerve fiber layer.

Sponsors & Collaborators

  • Heidelberg Engineering GmbH

    lead INDUSTRY

Principal Investigators

  • Mitchell Dul, OD · State University of New York College of Optometry

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2016-03-31
Completion
2016-03-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02666144 on ClinicalTrials.gov