Development and Clinical Validation of a Digital Eye-Tracking-Based Cover Test for Ocular Misalignment.

Authors

Eduardo Esteban-Ibañez, David Solanas, Marta Lacort-Beltrán, Marina Vilella, Xian Pan, Olimpia Castillo, Marta Ortín, Victoria Pueyo

Published in

Ophthalmology science. Volume 6. Issue 8. Pages 101261. Epub May 28, 2026.

Abstract

To develop and clinically validate the DIVE Cover Test (DCT), a portable eye-tracking-based digital implementation of the cover test, and to assess its diagnostic accuracy, agreement with the clinical reference standard (classic cover test [CCT]), and repeatability across cover-uncover test (CUT) and alternate cover test (ACT) phases and across horizontal and vertical axes.
A prospective clinical validation study.
Sixty-eight participants aged 3 to 74 years, including healthy controls and patients referred for strabismus evaluation.
Participants underwent 2 repetitions of the DCT and 2 independent CCT examinations performed by experienced clinicians at near distance (65 cm). The order of the 4 assessment blocks was randomized. Diagnostic performance (sensitivity/specificity) for detecting ocular misalignment was calculated using CCT classification as reference. Agreement and repeatability were evaluated using Bland-Altman mean differences and 95% limits of agreement (LoA), intraclass correlation coefficients (ICCs[2,k]), and Pearson correlations, separately for CUT versus ACT and horizontal versus vertical components.
Sensitivity and specificity for detection of ocular misalignment; intermethod agreement between DCT and CCT; test-retest repeatability of the DCT; and interobserver agreement of the CCT.
For detecting any deviations, the DCT achieved 85% sensitivity and 98% specificity in CUT, and 92% sensitivity and 87% specificity in ACT. Agreement between DCT and CCT was strongest for horizontal deviations, particularly during ACT (mean difference -1.3 prism diopters [PD]; LoA -8.0 and 5.4 PD). Intermethod ICCs were high for horizontal deviations (CUT 0.93; ACT 0.96) and moderate-to-high for vertical deviations (both phases 0.81). The DCT test-retest repeatability was excellent (ICC ≥0.93 across axes and phases), with narrow LoA (±3.8 to ±4.6 PD). Classic cover test interobserver agreement was also high (ICC ≥0.95 across phases and axes).
The DCT demonstrates high diagnostic accuracy, strong agreement with the clinical reference standard, and excellent repeatability. Phase-specific (CUT vs. ACT) and axis-specific (horizontal vs. vertical) analyses support the DCT as a practical, portable, and objective tool for quantifying ocular misalignment in clinical settings.
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

PMID:
42437112
Bibliographic data and abstract were imported from PubMed on 12 Jul 2026.

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