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

NCT07613580 | Recruiting DMC

• 1 other identifier: OE-VALi-2025-001
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Ophthalmopathy

Keywords

BCVA; ETDRS Protocol; Electronic Capture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Data discrepancies and errors

  Baseline (Same visit; assessments performed sequentially within minutes).

• Efficiency metrics

  Baseline (Same visit; assessments performed sequentially within minutes).

• User feedback

  Baseline (Same visit; assessments performed sequentially within minutes).

Study Arms (3)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• OptymEdge, LLC: lead

Study Sites (2)

Espaço Medico de Coimbra

Coimbra, 3030-015, Portugal

RECRUITING

TBIO - Escola Superior de Saúde do Politécnico do Porto

Porto, 4200-072, Portugal

RECRUITING

Related Publications (9)

• 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.

  PMID: 28005666 BACKGROUND

• 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.

  PMID: 11264133 BACKGROUND

• Schulz C, et al. Sources of variability in visual acuity measurement and implications for clinical trials. Br J Ophthalmol. 2016;100(1):62-68.

  BACKGROUND

• Ehlers JP, et al. Errors in visual acuity data recording in ophthalmic clinical trials: impact and mitigation strategies. Ophthalmology. 2020;127(6):747-754.

  BACKGROUND

• 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.

  PMID: 20126505 BACKGROUND

• 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.

  PMID: 18234989 BACKGROUND

• European Medicines Agency (EMA). Guideline on Clinical Investigation of Medicinal Products in the Treatment of Chronic Primary Glaucoma and Ocular Hypertension. EMA/CHMP; 2012.

  BACKGROUND

• U.S. Food and Drug Administration (FDA). Guidance for Industry: Ophthalmic Drug Products - Clinical Pharmacology Considerations. Silver Spring, MD: FDA; 2015.

  BACKGROUND

• 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.

  PMID: 12566024 BACKGROUND

MeSH Terms

Conditions

Eye Diseases

Study Officials

• Ana Rita Santos, PhD

  OptymEdge, LLC

  STUDY DIRECTOR

Central Study Contacts

Tânia Mesquita, BSc

CONTACT

+351 239484348; emc.trials@oftalmologia.co.pt

Ana Claudia Rocha, BSc

CONTACT

abr@ess.ipp.pt

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: May 29, 2026
• Study Start: January 12, 2026
• Primary Completion: June 30, 2026
• Study Completion: June 30, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (2)