Normal Eyes
Conditions
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).
Interventions
DEVICEOCT imaging
OCT imaging on Normal Eyes without any filter and with various ND filters as per protocol
Sponsors
Heidelberg Engineering GmbH
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | through study completion, an average of one day | All AEs |
Countries
United States
Outcome results
None listed