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

Completed

• Conditions: Normal Eyes

• Registration Number: NCT04961398
• Lead Sponsor: Heidelberg Engineering GmbH

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-06-17
• Study Start: 2021-06-21
• Primary Completion: 2021-06-24
• Study Completion: 2021-06-24
• Study First Submitted QC: 2021-07-13
• Study First Posted: 2021-07-14
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-10
• Last Update Posted: 2025-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Adverse Events	through study completion, an average of one day	All AEs

Trial Locations

Locations (1)

Heidelberg Engineering, Inc.; 🇺🇸 Franklin, Massachusetts, United States