OphthalmopathyVALiCAPTURENCT07613580
Assessing Agreement Between Acuvera Capture and Paper-Based Methods for BCVA Data Recording in Ophthalmic Trials
An observational study of Ophthalmopathy, run by OptymEdge, LLC at 2 sites in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ophthalmopathy
- How many people
- 90 participants
- Where
- 2 sitesPortugal
- Study dates
- 12 Jan 2026to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ana Claudia Rocha, BSc contact
Portugal2 sites, 2 recruiting
- Recruiting
Espaço Medico de Coimbra
Coimbra, 3030-015
Tânia Mesquita, BSc, +351 239484348, emc.trials@oftalmologia.co.pt
Rufino Silva, PhD
- Recruiting
TBIO - Escola Superior de Saúde do Politécnico do Porto
Porto, 4200-072
Ana Claudia Rocha, BSc, +351 22 206 1000, abr@ess.ipp.pt
Catarina Mateus, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Ophthalmopathy
- Keywords
- BCVA, ETDRS Protocol, Electronic Capture
- Medical subject headings
- Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 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
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).
Measured: 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).
Measured: 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.
Measured: Baseline (Same visit; assessments performed sequentially within minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start12 Jan 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for OphthalmopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OptymEdge, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ana Rita Santos, PhD, Study director, OptymEdge, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613580
- Sponsor's protocol ID
- OE-VALi-2025-001
- Acronym
- VALiCAPTURE
- Status last verified
- May 2026
- First submitted
- 13 Feb 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28005666Rosser 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.
PubMed 11264133Schulz 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.
PubMed 20126505Csaky 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.
PubMed 18234989European 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.
PubMed 12566024
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07613580
- Acronym / sponsor ID
- VALiCAPTURE / OE-VALi-2025-001
- Conditions
- Ophthalmopathy
- Keywords
- BCVA, ETDRS Protocol, Electronic Capture
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- OptymEdge, LLCIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Level of agreement in BCVA data recording between Acuvera Capture and paper-based methods
Time frame: Difference of BCVA score results between paper and Acuvera Capture, in the same single visit - Baseline. (Same visit; assessments performed sequentially within minutes).
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]
3 secondary outcomes
Data discrepancies and errors
Time frame: Baseline (Same visit; assessments performed sequentially within minutes).
Efficiency metrics
Time frame: Baseline (Same visit; assessments performed sequentially within minutes).
User feedback
Time frame: Baseline (Same visit; assessments performed sequentially within minutes).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Background: PubMed 28005666Cole 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.
- Background: PubMed 11264133Rosser 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.
- BackgroundSchulz C, et al. Sources of variability in visual acuity measurement and implications for clinical trials. Br J Ophthalmol. 2016;100(1):62-68.
- BackgroundEhlers JP, et al. Errors in visual acuity data recording in ophthalmic clinical trials: impact and mitigation strategies. Ophthalmology. 2020;127(6):747-754.
- Background: PubMed 20126505Kaiser 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.
- Background: PubMed 18234989Csaky 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.
- BackgroundEuropean Medicines Agency (EMA). Guideline on Clinical Investigation of Medicinal Products in the Treatment of Chronic Primary Glaucoma and Ocular Hypertension. EMA/CHMP; 2012.
- BackgroundU.S. Food and Drug Administration (FDA). Guidance for Industry: Ophthalmic Drug Products - Clinical Pharmacology Considerations. Silver Spring, MD: FDA; 2015.
- Background: PubMed 12566024Beck 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ana Claudia Rocha, BSc contact
Ana Rita Santos, PhD study director
OptymEdge, LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ophthalmopathy, run by OptymEdge, LLC at 2 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tânia Mesquita, BSc (+351 239484348, emc.trials@oftalmologia.co.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of agreement in BCVA data recording between Acuvera Capture and paper-based methods (time frame: Difference of BCVA score results between paper and Acuvera Capture, in the same single visit - Baseline. (Same visit; assessments performed sequentially within minutes).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07613580, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.