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.
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