An Observational Comparative Study Assessing Agreement Between Acuvera Capture and Paper-Based Methods for Best Corrected Visual Acuity Data Recording in Ophthalmic Clinical Trials

What this Trial Is About

Researchers are evaluating how well the Acuvera Capture app compares to traditional paper methods for recording Best Corrected Visual Acuity (BCVA) in eye health clinical trials. BCVA is a key measure used to assess vision function and treatment effects in various eye diseases. This study aims to see if the electronic system matches or improves upon paper-based recording in accuracy, consistency, and error reduction to support its use in clinical research. Participants will have their BCVA tested during a single visit using both paper and the Acuvera Capture app. The order of testing will be randomized to reduce bias. The study includes three groups based on vision levels: normal or near-normal vision, mid-range vision, and low vision including very poor sight. Data from paper forms will be entered into electronic case report forms, while the electronic app data will be exported directly. During the visit, participants undergo BCVA testing with both recording methods. Researchers will compare the agreement between the two data sets, evaluate discrepancies and errors, assess efficiency, and gather user feedback. The study involves 90 adults and aims to complete within two months. The main measurement is the difference in BCVA scores recorded by the two methods during the same visit.

Assessing Agreement Between Acuvera Capture and Paper-Based Methods for BCVA Data Recording in Ophthalmic Trials