Clinical Validation of Apollo™, A Novel Web-Based Tool for Refractive Error Self-Assessment

Area of Science:

• Ophthalmology and Vision Science
• Digital Health Technologies
• Biomedical Engineering

Background:

• Refractive errors are a primary cause of visual impairment and carry significant economic implications.
• Digital refraction systems offer potential to enhance eye care accessibility, particularly for underserved populations.

Purpose of the Study:

• To evaluate Apollo™, a novel web-based self-assessment system, for measuring spherical equivalent (SEQ) of refractive errors.
• To compare the accuracy of Apollo™'s SEQ measurements against traditional manifest refraction performed by ophthalmologists.

Main Methods:

• A prospective, single-center, single-blind, non-randomized study involving 63 eyes of 64 healthy adults (aged 18-40).
• Participants underwent both manifest subjective refraction and digital refraction using the Apollo™ system.
• Exclusion criteria included significant astigmatism (>3.00 D) and wide SEQ range (beyond -4.00 D to +4.00 D).

Main Results:

• No statistically significant difference was found between SEQ measured by Apollo™ (mean -1.20 ± 1.11 D) and manifest refraction (mean -1.17 ± 1.14 D; p=0.67).
• Bland-Altman analysis revealed a bias of 0.03 ± 0.90 D, with 95% limits of agreement from -1.73 D to 1.78 D.
• The system demonstrated moderate to good reliability (ICC=0.69) and high diagnostic accuracy (96.2%) for detecting refractive status in myopic individuals.

Conclusions:

• Apollo™ exhibits moderate-to-good reliability and high accuracy in assessing refractive status, especially among myopes.
• The system shows promise as a valuable digital screening tool for refractive errors.
• Further large-scale studies are recommended to refine the predictive algorithm of the Apollo™ system.