Lani-Louzada, Rafael
Negreiros, Marco Antonio
Andrade-Silva, Jessica https://orcid.org/0000-0002-9837-964X
Ribeiro, Lucas Zago
Pimentel, Luis Guilherme Milesi
Souza, Rodrigo Guimarães de
Engelbrecht, Carolina
Neves, Deangelo Gomes
de Andrade Lessa, Daniel
Lottenberg, Cláudio Luiz
Yasaki, Erika Sayuri
Article History
Received: 27 October 2025
Accepted: 18 March 2026
First Online: 28 March 2026
Declarations
:
: Written informed consent was obtained from all participants. The study protocol adhered to the Tenets of Declaration of Helsinki and was approved by the Hospital Israelita Albert Einstein’s Ethics Review Board (registered number: 76524623.3.0000.0071; Approval number: 6.631.190). Following institutional guidelines for diagnostic validation studies, this research was designed as a prospective evaluation of software accuracy. Since the protocol did not involve therapeutic interventions, treatment allocation, or modifications to standard patient management, it was not prospectively registered in a clinical trial database. Nevertheless, the study adhered to the STARD (Standards for Reporting Diagnostic Accuracy) guidelines and was conducted under strict Institutional Review Board oversight.
: Not applicabe.
: Negreiros, MA is the cofounder of the company Eyecare Health Company that developed the Apollo™. Lani-Louzada, R is the Medical Consultant of Eyecare Health Company. Lessa, DA and Neves, DG are employees of Eyecare Health Company. All other authors declare no conflict of interest.
: Not applicable.