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

Recruiting Observational Study
Ophthalmopathy
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
90 (estimated)
Sponsor
OptymEdge, LLC · Industry
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About This Trial
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 support…
Trial Locations
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Eligibility Criteria
90 adult participants (≈180 eyes) with the following BCVA levels, will be included: * 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 participa…
Contacts

Tânia Mesquita, BSc

+351 239484348

emc.trials@oftalmologia.co.pt

CONTACT

Ana Claudia Rocha, BSc

abr@ess.ipp.pt

CONTACT