Pivotal Trial Toward Effectiveness of Self-administered OCT in Neovascular Age-related Macular Degeneration. Report 2-Artificial Intelligence Analytics

Abstract

Purpose: To validate the performance of the Notal OCT Analyzer (NOA) in processing self-administered OCT images from an OCT system designed for home use (home OCT [HOCT]) as part of a pivotal study aimed at achieving de novo United States Food and Drug Admininstration marketing authorization.

Design: A prospective quantitative cross-sectional artificial intelligence study.

Participants: The study enrolled adults aged ≥55 years diagnosed with neovascular age-related macular degeneration (nAMD) in ≥1 eligible eye with a best-corrected visual acuity of 20/320 or better.

Methods: Participants self-imaged 4 times on each of 2 HOCT devices and once with an in-office OCT (IO-OCT) device during a single visit. Scans were segmented by the NOA and human graders at a certified reading center (RC).

Main outcome measures: Intradevice and interdevice repeatability and reproducibility of total retinal hyporeflective (TRO) volume estimation by the NOA on HOCT-acquired images as compared with that of RC graders on IO-OCT-acquired images. Additionally, to assess the performance of the NOA in segmentation of TRO over multiple B-scans as compared with RC graders.

Results: Self-imaging was performed successfully by 387 participants in 2451 of 2616 attempts (93.7%). For repeatability, the coefficient of variance for NOA was 11.1% for eyes with >10 volume units of TRO imaged with HOCT compared with 16.4% for RC graders segmenting IO-OCT images. The median DICE similarity coefficients for segmentation of TRO by NOA vs. Grader 1, Grader 2, and Grader 3; Grader 1 vs. Grader 2 and Grader 3; and Grader 2 vs. Grader 3 were 0.68, 0.68, 0.61, 0.72, 0.63, 0.70, respectively.

Conclusions: The performance of NOA supports the intended use of the system as a tool to monitor TRO at home between routine clinical visits in support of the management of nAMD.

Financial disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Keywords: Age-related macular degeneration; Artificial intelligence; Home OCT; Neovascular; Telemedicine.

Figure 1

The Home OCT physician report includes the following elements: (A) segmentation mask over each B-scan that is color coded to SRO and IRO, (B) TRO volume value, (C) en face projection maps for SRO and IRO for each volume scan, and (D) trajectory of the TRO volume over time. A notification setting panel (E) allows the physician to set time and TRO volume thresholds to prompt notifications to review the report. IRO = intraretinal hyporeflective spaces; NOA = Notal OCT Analyzer; SRO = subretinal hyporeflective spaces; TRO = total retinal hyporeflective spaces; VA = visual acuity; VU = volume unit.

Figure 2

Enrollment diagram of participants. IO-OCT = in-office OCT; nAMD = neovascular age-related macular degeneration.

Figure 3

Review of outlier cases in the bins with a higher CV% revealed the presence of distinct distributions of hyporeflective spaces predominantly located at the edges (marked in red) of the scan field, where small variations in the point of fixation can cause large VUs variations and impact the observed precision, as seen in these 2 illustrative examples. CV% = coefficient of variance; HOCT = home OCT; IRO = intraretinal hyporeflective spaces; SRO = subretinal hyporeflective spaces; VU = volume unit.

Figure 4

NOA output example from the 5-week Visualization Study depicting a typical posttreatment trajectory with progressive hyporeflective spaces resolution. The volume of the hyporeflective spaces in the last ∼10 days of scanning is close to 0 with small fluctuations that are likely of minimal clinical relevance. IRO = intraretinal hyporeflective spaces; NOA = Notal OCT Analyzer; SRO = subretinal hyporeflective spaces; TRO = total retinal hyporeflective spaces; VU = volume unit.