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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ophthalmopathy

Detailed Description

Background and Rationale: Best Corrected Visual Acuity (BCVA) is the most widely accepted and clinically meaningful functional endpoint in ophthalmic clinical trials. It is routinely used to assess treatment efficacy, disease progression, and visual function across a broad spectrum of ocular diseases, including age-related macular degeneration (AMD), diabetic retinopathy, and inherited retinal diseases. Regulatory authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) recognize BCVA as a primary endpoint in pivotal trials, and therapeutic approvals often hinge on statistically and clinically significant changes in BCVA outcomes (1-3).

Despite this critical role, BCVA data collection in clinical trials remains vulnerable when recorded on traditional paper forms. Common challenges include:

Calculation errors: Manual determination of the total number of letters correctly identified during BCVA testing is prone to human error, particularly when partial lines are read or when examiners must manually apply line-by-line scoring rules. Miscounting or incorrect summation of letter scores can result in inaccurate BCVA values and distort subsequent data analyses. These errors are inherent to paper-based recording processes and highlight the need for standardized, automated systems capable of performing real-time calculations to ensure data accuracy and consistency across study sites (1,2,3).

Transcription Errors: Manual transfer of BCVA scores from testing charts to case report forms can result in numerical misentries and calculation mistakes (4).

Omission and Misrecording: Missed data points, illegible handwriting, or recording the wrong line/letter score can compromise data integrity (5).

Protocol Deviations: Variations in testing procedures (e.g., incorrect testing distance, inappropriate prompting, or examiner bias) are not always detected in real time, introducing variability and bias (6).

Delayed Error Detection: Errors are often identified only retrospectively, during central reading or data monitoring, causing delays in data cleaning, increased trial costs, and, in some cases, regulatory queries (7).

Digital capture solutions such as Acuvera Capture address these limitations by embedding real-time quality control at the point of care. The application incorporates automated error detection, warning systems for protocol deviations, and standardized workflow guidance, ensuring higher data fidelity. By minimizing calculation, transcription and protocol errors, Acuvera Capture has the potential to strengthen data reliability, streamline trial conduct, and increase regulatory confidence in BCVA endpoints.

Given that BCVA is the most critical functional endpoint in ophthalmic clinical trials, even small improvements in accuracy and reproducibility can substantially impact study outcomes, regulatory acceptability, and sponsor credibility. This study will directly compare Acuvera Capture against paper-based recording to validate data agreement and assess error rates, efficiency, and usability, thereby generating essential evidence to support digital transformation of BCVA data collection.

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Tânia Mesquita, BSc; Phone Number: +351 239484348; Email: emc.trials@oftalmologia.co.pt
• Study Contact Backup: Name: Ana Claudia Rocha, BSc; Email: abr@ess.ipp.pt

Study Locations

• Portugal
  • Coimbra, Portugal, 3030-015
    • Recruiting
    • Espaço Medico de Coimbra
    • Contact: Tânia Mesquita, BSc; Phone Number: +351 239484348; Email: emc.trials@oftalmologia.co.pt
    • Principal Investigator: Rufino Silva, PhD
  • Porto, Portugal, 4200-072
    • Recruiting
    • TBIO - Escola Superior de Saúde do Politécnico do Porto
    • Contact: Ana Claudia Rocha, BSc; Phone Number: +351 22 206 1000; Email: abr@ess.ipp.pt
    • Principal Investigator: Catarina Mateus, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Normal/Near Normal BCVA Range; 30 participants (33%) in the normal/near-normal BCVA range (≤0.3 logMAR ≥70 letters); ≈20/40 or better);
Mid-range BCVA; 30 participants (33%) with mid-range BCVA (0.4-0.9 logMAR (36-69 letters); 20/50 to 20/200)
Low Vision BCVA; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]	Difference of BCVA score results between paper and Acuvera Capture, in the same single visit - Baseline. (Same visit; assessments performed sequentially within minutes).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline (Same visit; assessments performed sequentially within minutes).
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).	Baseline (Same visit; assessments performed sequentially within minutes).
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.	Baseline (Same visit; assessments performed sequentially within minutes).

Collaborators and Investigators

• Sponsor: OptymEdge, LLC
• Investigators: Study Director: Ana Rita Santos, PhD, OptymEdge, LLC

Publications and helpful links

General Publications

• Cole ED, Ferrara D, Novais EA, Louzada RN, Waheed NK. CLINICAL TRIAL ENDPOINTS FOR OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY IN NEOVASCULAR AGE-RELATED MACULAR DEGENERATION. Retina. 2016 Dec;36 Suppl 1:S83-S92. doi: 10.1097/IAE.0000000000001338.
• Rosser DA, Laidlaw DA, Murdoch IE. The development of a "reduced logMAR" visual acuity chart for use in routine clinical practice. Br J Ophthalmol. 2001 Apr;85(4):432-6. doi: 10.1136/bjo.85.4.432.
• Schulz C, et al. Sources of variability in visual acuity measurement and implications for clinical trials. Br J Ophthalmol. 2016;100(1):62-68.
• Ehlers JP, et al. Errors in visual acuity data recording in ophthalmic clinical trials: impact and mitigation strategies. Ophthalmology. 2020;127(6):747-754.
• Kaiser PK. Prospective evaluation of visual acuity assessment: a comparison of snellen versus ETDRS charts in clinical practice (An AOS Thesis). Trans Am Ophthalmol Soc. 2009 Dec;107:311-24.
• Csaky KG, Richman EA, Ferris FL 3rd. Report from the NEI/FDA Ophthalmic Clinical Trial Design and Endpoints Symposium. Invest Ophthalmol Vis Sci. 2008 Feb;49(2):479-89. doi: 10.1167/iovs.07-1132. No abstract available.
• European Medicines Agency (EMA). Guideline on Clinical Investigation of Medicinal Products in the Treatment of Chronic Primary Glaucoma and Ocular Hypertension. EMA/CHMP; 2012.
• U.S. Food and Drug Administration (FDA). Guidance for Industry: Ophthalmic Drug Products - Clinical Pharmacology Considerations. Silver Spring, MD: FDA; 2015.
• Beck RW, Moke PS, Turpin AH, Ferris FL 3rd, SanGiovanni JP, Johnson CA, Birch EE, Chandler DL, Cox TA, Blair RC, Kraker RT. A computerized method of visual acuity testing: adaptation of the early treatment of diabetic retinopathy study testing protocol. Am J Ophthalmol. 2003 Feb;135(2):194-205. doi: 10.1016/s0002-9394(02)01825-1.

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: February 13, 2026
• First Submitted That Met QC Criteria: May 21, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: BCVA; ETDRS Protocol; Electronic Capture
• Additional Relevant MeSH Terms: Eye Diseases
• Other Study ID Numbers: OE-VALi-2025-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No