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.

Study Overview

• Status: Completed
• Conditions: Normal Eyes
• Intervention / Treatment: Device: OCT imaging

Detailed Description

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 (Actual): 9

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Franklin, Massachusetts, United States, 02038
      • Heidelberg Engineering, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

adults with healthy eyes

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
OCT speed 85 KHz; predicate speed	Device: OCT imaging; OCT imaging on Normal Eyes without any filter and with various ND filters as per protocol
OCT speed 125 KHz; investigational speed	Device: OCT imaging; OCT imaging on Normal Eyes without any filter and with various ND filters as per protocol
OCT speed 20 KHz; investigational speed	Device: OCT imaging; OCT imaging on Normal Eyes without any filter and with various ND filters as per protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Macular layer thicknesses	ETDRS grid (9 sectors)	during the intervention
Bruch's Membrane Opening (BMO)-Minimum Rim Width (MRW)	Classification chart (6 sectors)	during the intervention
Peripapillary Retinal Nerve Fiber Layer Thickness (RNFLT)	Classification chart (6 sectors)	during the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	All AEs	through study completion, an average of one day

Collaborators and Investigators

• Sponsor: Heidelberg Engineering GmbH
• Investigators: Principal Investigator: Valerie M Leung, BOptom BS, Heidelberg Engineering, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2021
• Primary Completion (Actual): June 24, 2021
• Study Completion (Actual): June 24, 2021

Study Registration Dates

• First Submitted: June 17, 2021
• First Submitted That Met QC Criteria: July 13, 2021
• First Posted (Actual): July 14, 2021

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: S-2021-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No