June 2020
Volume 61, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2020
Statistical analysis in macula thickness, RPE elevation and flow deficit measurements between two different swept-source optical coherence tomography hardware platforms
Author Affiliations & Notes
  • Sophie Kubach
    Carl Zeiss Meditec, Inc, Dublin, California, United States
  • Luis De Sisternes
    Carl Zeiss Meditec, Inc, Dublin, California, United States
  • Simon Antonio Bello
    Carl Zeiss Meditec, Inc, Dublin, California, United States
  • Roger A. Goldberg
    Bay Area Retina Associates, Walnut Creek, California, United States
  • Footnotes
    Commercial Relationships   Sophie Kubach, Carl Zeiss Meditec, Inc (E); Luis De Sisternes, Carl Zeiss Meditec, Inc (E); Simon Bello, Carl Zeiss Meditec, Inc (E); Roger Goldberg, Carl Zeiss Meditec, Inc (C)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2020, Vol.61, 5292. doi:
  • Views
  • Share
  • Tools
    • Alerts
      ×
      This feature is available to authenticated users only.
      Sign In or Create an Account ×
    • Get Citation

      Sophie Kubach, Luis De Sisternes, Simon Antonio Bello, Roger A. Goldberg; Statistical analysis in macula thickness, RPE elevation and flow deficit measurements between two different swept-source optical coherence tomography hardware platforms. Invest. Ophthalmol. Vis. Sci. 2020;61(7):5292.

      Download citation file:


      © ARVO (1962-2015); The Authors (2016-present)

      ×
  • Supplements
Abstract

Purpose : As swept-source optical coherence tomography (SS-OCT) instruments evolve to make use of the latest technologies, it is important to ensure consistent measurements when changes are made to these instruments. This is particularly critical for sites that are using these devices for ongoing longitudinal studies. The purpose of this study is to assess the continuity of measurements made with swept-source instruments of macula thickness, elevation of the retina pigment epithelium (RPE) and choriocapillaris (CC) flow void deficits when instruments get upgraded with new hardware components.

Methods : A total of 18 diseased eyes were scanned on the original and upgraded PLEX® Elite 9000 instruments. The upgraded version included a new laser source and detection modules. For each instrument, the difference in signal-to-noise ratio before and after the upgrade was within 1.5 dB. For each eye, an Angio 6mmx6mm scan centered on the macula was acquired 3 times. Macula thickness, RPE elevation, and CC flow void deficit size and area density were reported for each scan. A R-squared value of at least 0.95 or higher was defined as the acceptance criteria to verify the linear relationship in macula thickness and RPE elevation measurement between the 2 versions of instruments.

Results : When considering the macula thickness (Figure 1) and RPE elevation (Figure2), we found a very good fit of the linear regression model to the data (R2 > 0.99 for the macula thickness, R2 > 0.96 for the RPE elevation). The reported p-value from a t-test was less than 0.05; indicating a statistically significant difference in the macula measurement, however this difference was found to be clinically insignificant. When considering the CC flow deficit measurements (Figure 3), the results show a good correlation with a p-value of 0.93.

Conclusions : The results from this clinical study show substantial equivalence in the measurement of macula thickness, RPE elevation and CC flow deficits by the instrument before and after a hardware upgrade. As higher performance hardware components become available to upgrade SS-OCT instruments, it is important to run a thorough analysis to insure continuity in ongoing clinical trials.

This is a 2020 ARVO Annual Meeting abstract.

 

 

×
×

This PDF is available to Subscribers Only

Sign in or purchase a subscription to access this content. ×

You must be signed into an individual account to use this feature.

×