Study Purpose: To evaluate the level of agreement between the Acuvera Capture application and traditional paper-based methods for recording Best Corrected Visual Acuity (BCVA) in ophthalmic clinical trials. The study aims to determine whether the electronic capture system provides equivalent or improved accuracy, consistency, and error reduction compared with paper-based recording, thereby supporting its potential adoption as a reliable method for BCVA data collection in clinical research.
30 participants (33%) in the normal/near-normal BCVA range (≤0.3 logMAR ≥70 letters); ≈20/40 or better);
30 participants (33%) with mid-range BCVA (0.4-0.9 logMAR (36-69 letters); 20/50 to 20/200)
30 participants (33%) with low vision BCVA (≥ 1.0 logMAR (≤35 letters); worse than 20/200) including off-chart acuities using protocol low-vision procedures).
Adults ≥18 years old
Any condition preventing reliable completion of BCVA testing (e.g., severe cognitive impairment, language barriers)
Inability or unwillingness to comply with study requirements
Non-ophthalmic condition that precludes safe or reliable testing (e.g., immediate post-operative systemic status preventing cooperation).
Any circumstance that, in the investigator's opinion, makes the eye/participant unsuitable for accurate BCVA testing or for completing both data-capture methods during the same visit.
Overall, a total of 90 participants, evenly distributed across three BCVA strata (normal/near-normal, mid-range, and low vision; approximately 30 participants per group), remains appropriate for this study's aims: it ensures representation across the acuity spectrum while providing decision-grade precision for concordance (ICC/Bland-Altman), informative bounds on error rates, and pragmatic sensitivity to workflow time differences, without over-scaling an observational validation.
Other
Prospective
Not listed
Level of agreement in BCVA data recording between Acuvera Capture and paper-based methods
Level of agreement in BCVA data recording between Acuvera Capture and paper-based methods, expressed using the statistical measurement of concordance, intraclass correlation coefficient \[ICC\]
Data discrepancies and errors
Frequency and types of discrepancies between paper and electronic capture (e.g., calculation or transcription errors, missing data, protocol deviations). Error rates stratified by category (e.g., digit transposition, incomplete fields, illegible entries).
Efficiency metrics
Time to complete BCVA data entry (per assessment and per session). Time to query resolution (if applicable). Overall workflow efficiency (average time saved per visit).
User feedback
A survey (Acuvera Capture Experience Survey) is going to be sent to the examiners, that will answer 7 questions about the experience of using Acuvera Capture. The Survey uses a scale of 1-5 (one being the worst and 5 being the best). Usability ratings from certified examiners (measured through structured questionnaires or Likert scales) Questions 1 to 3 of the Acuvera Capture Survey. Qualitative feedback on workflow integration, ease of use, and error prevention features. Question 3 and 4 of the Acuvera Capture Survey. Examiner preference between electronic vs. paper methods. - Questions 5 to 7 of the Acuvera Capture Survey.
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