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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.