Can a smartphone app replace paper for eye exams in clinical trials?
NCT ID NCT07613580
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether a smartphone app called Acuvera Capture can record eye test results as accurately as the traditional paper method. Researchers will compare the two methods in 90 adults with different levels of vision, from normal to low vision. The goal is to see if the app reduces errors and makes data collection more reliable for future eye disease studies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could show that using a smartphone app to record eye test results is more accurate and error-free than paper, potentially improving data quality in future eye disease studies.
- What could go wrong
- This is a small, early-stage observational study (90 people) that does not test any treatment. It only checks if the app matches paper records, so even positive results won't directly lead to a new therapy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 participants (33%) with low vision BCVA (≥ 1.0 logMAR (≤35 letters); worse than 20/200) including off-chart acuities using protocol low-vision procedures). Inclusion Criteria: * Adults ≥18 years old * Able and willing to provide written informed consent * Capable of performing BCVA testing procedures according to study requirements * All BCVA ranges are eligible, including off-chart acuities (e.g., count fingers, hand motion, light perception) irrespective of the presence or absence of ocular disease. Exclusion Criteria: * 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. Number of Sites: 2 ophthalmic clinical research centers Portugal) Number of Countries: Portugal Number of Visits: One study visit per participant Duration: 2 months Participants will undergo BCVA testing at a single visit using both paper-based recording and electronic capture with Acuvera Capture. Testing order will be randomized to minimize bias. Paper data will be inserted by the examiners or study coordinator into the study eCRF. Electronic capture data will be exported directly from the app.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Espaço Medico de Coimbra
RECRUITINGCoimbra, 3030-015, Portugal
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TBIO - Escola Superior de Saúde do Politécnico do Porto
RECRUITINGPorto, 4200-072, Portugal
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