Spectralis OCT
DeviceMeasurement of structural parameters of the optic nerve head (ONH), in particular, the neuroretinal rim of the ONH, and the peripapillary retinal nerve fiber layer.
NCT Number: NCT02666144
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.
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Notify Me18 year and older
All sexes
Observational
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Minimum requirements are:
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.
Time frame: 4 weeks
Agreement (Differences) of peripapillary retinal nerve fiber layer thickness in sectors temporal, nasal, nasal superior, nasal inferior, temporal superior and temporal inferior when measured with two different software versions.
Heidelberg Engineering GmbH
Industry
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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.
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