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OpenTrials
Completed

NCT Number: NCT04961398

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

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

Completed

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Key information

Conditions

Normal Eyes

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Heidelberg Engineering, Inc.

Franklin, Massachusetts, 02038, United States

About this study

The objectives of this study are to

  • Directly compare parameter measurements generated on scans acquired at different speed modes with various levels of signal-to-noise ratio (SNR).
  • 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).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
  • Age ≥ 22
  • Both eyes with an age-appropriate normal appearing OCT as determined by an investigator

Exclusion criteria

  • Subjects unable to read or write
  • Subjects with ocular media not sufficiently clear to obtain acceptable study-related imaging as determined by OCT imaging (without neutral optical density filter)
  • Subjects who cannot tolerate the imaging procedures

Treatment and study plan

OCT imaging

Device

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

Primary outcomes

  1. Macular layer thicknesses

    Time frame: during the intervention

    ETDRS grid (9 sectors)

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

    Time frame: during the intervention

    Classification chart (6 sectors)

  3. Peripapillary Retinal Nerve Fiber Layer Thickness (RNFLT)

    Time frame: during the intervention

    Classification chart (6 sectors)

Secondary outcomes

  1. Adverse Events

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

    All AEs

Sponsors and collaborators

Lead sponsor

Heidelberg Engineering GmbH

Industry

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 14, 2021
Registry last updated
Sep 16, 2025

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.

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