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

Heidelberg Engineering

Status: Completed

Conditions: Normal Eyes

Treatments: Device: OCT imaging

Study type: Observational

Funder types: Industry

Identifiers

NCT04961398

S-2021-1

Details and patient eligibility

About

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

Full 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).

Enrollment: 9 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

9 participants in 3 patient groups

OCT speed 85 KHz

Description:

predicate speed

Treatment:

Device: OCT imaging

OCT speed 125 KHz

Description:

investigational speed

Treatment:

Device: OCT imaging

OCT speed 20 KHz

Description:

investigational speed

Treatment:

Device: OCT imaging