Evaluation of Heidelberg Engineering SPECTRALIS OCT Signal to Noise Ratio Effect on Parameter Measurements

Heidelberg Engineering GmbH9 enrolled

Overview

Evaluation of effect of various OCT scan speeds and filters on parameter measurements.

The objectives of this study are to 1. Directly compare parameter measurements generated on scans acquired at different speed modes with various levels of signal-to-noise ratio (SNR). 2. Evaluate the effects of SNR, as determined by the device's Q score, on parameters derived from segmentation results, i.e., thickness of peripapillary retinal nerve fiber layer on circle scans (pRNFL), minimum rim width of optical nerve head (MRW), and macular layer thicknesses (Retina, GCL, IPL).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Normal Eyes

Interventions

OCT imagingDEVICE

OCT imaging on Normal Eyes without any filter and with various ND filters as per protocol

Eligibility

Sex: ALLMin age: 22 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Able and willing to undergo the test procedures, sign informed consent, and follow instructions. 2. Age ≥ 22 3. Both eyes with an age-appropriate normal appearing OCT as determined by an investigator Exclusion Criteria: 1. Subjects unable to read or write 2. Subjects with ocular media not sufficiently clear to obtain acceptable study-related imaging as determined by OCT imaging (without neutral optical density filter) 3. Subjects who cannot tolerate the imaging procedures

Locations (1)

Heidelberg Engineering, Inc.

Franklin, Massachusetts, United States

Outcomes

Primary Outcomes

Macular layer thicknesses

ETDRS grid (9 sectors)

Time frame: during the intervention

Bruch's Membrane Opening (BMO)-Minimum Rim Width (MRW)

Classification chart (6 sectors)

Time frame: during the intervention

Peripapillary Retinal Nerve Fiber Layer Thickness (RNFLT)

Classification chart (6 sectors)

Time frame: during the intervention

Secondary Outcomes

Adverse Events

All AEs

Time frame: through study completion, an average of one day

Data from ClinicalTrials.gov

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