1. Introduction
Home monitoring and self-testing are a major current focus in medicine. The COVID-19 pandemic prompted the integration of telemedicine into ophthalmic practice, known as teleophthalmology [
1], whereby healthcare providers had to adapt creative approaches to ensure effective diagnosis and treatment while safeguarding patients and medical staff [
2]. Remote assessment of visual function is an important area of research that requires the development of home-based, patient-oriented technologies [
3].
Remote patient monitoring, facilitated by home-based systems, holds the potential to enhance accessibility to healthcare services and improve patient outcomes across a wide range of ocular conditions, mainly in patients with chronic eye conditions or lack of access to office-based examinations. Additionally, home monitoring can enhance the quality of care, leading to improved outcomes and reduced healthcare costs [
4].
Visual acuity (VA) is a fundamental measure of visual function in clinical practice [
5]. This is the initial test that is performed in a clinic [
6] that gives an indication of refractive error, media abnormalities, macular function, and the integrity of the visual pathways [
7]. VA theory revolves around assessing the clarity or sharpness of vision, which is most commonly measured using the Snellen chart. Developed by Herman Snellen in the 1860s, the Snellen chart is a tool featuring rows of black symbols on a white background that decrease in size, used to determine the smallest letters a person can read from a specific distance, typically 20 feet, which represents the minimal angle of resolution. The Snellen chart is commonly used to measure VA in ophthalmology and optometry [
7]. Snellen charts may be used at a distance (6 m) or near (40 cm) [
8,
9]. It is important to recognize that impaired near vision can have a significant impact on quality of life, similar to the effects of decreased distance vision [
10]. Furthermore, there is a strong correlation between distance VA and near VA [
11], as measured with the Rosenbaum Pocket Vision Screener (RPVS), which is a commonly used Snellen-based near card in ophthalmic practice [
3].
Various digital tools have emerged in recent years to monitor patients’ VA [
12], including smartphone-based applications such as V@home [
13], Peek Acuity [
14], GoCheck Kids [
1], Sightbook [
15], TreC Oculistica [
16], the web-based index test [
17], the Pocket Vision Screener [
18], self-administered tests, such ad as the Early Treatment Diabetic Retinopathy Study (ETDRS) home VA test [
2] and the Accustat
® [
3], and even the first smart TV-based VA test, the Democritus Digital Visual Acuity Test (DDiVAT) [
19]. However, though a low mean difference between digital tools and the standard charts and clinical equivalence indications were previously reported, the wide 95% limits of agreement revealed the lower precision of the digital self-assessments, especially in patients with decreased VA [
20]. Moreover, in technologically challenged populations, digital tools may not be effective.
The necessity to develop a new VA card test for self-use and home monitoring stems from the limitations observed in both traditional in-clinic assessments and existing digital tools for VA measurement. Traditional methods, such as the Snellen and RPVS methods, require in-person visits to healthcare facilities, posing challenges for individuals with mobility issues, chronic conditions, or those residing in remote areas. Digital tools, despite their innovation, have shown variability in precision, particularly in patients with reduced VA, and may not be accessible or user-friendly for all populations, especially those with technological limitations [
20]. Additionally, the implementation of digital VA tools remains underdeveloped, which could significantly improve the applicability of these tests for self-administration or evaluations by non-specialists. [
12] The COVID-19 pandemic further underscored the importance of remote healthcare capabilities, including teleophthalmology, emphasizing the need for reliable, non-digital, self-administered VA tests, for populations that are less comfortable with technology or without access to digital devices. The “Hadassah Self-Visual Acuity Screener” (HSVA) was thus developed to address these gaps, offering a practical solution for consistent, accurate home-based VA monitoring and reducing dependency on clinical visits, thereby enhancing healthcare accessibility and efficiency.
The objective of this study was to create and validate a user-friendly non-digital near VA card test, the HSVA, that will enable card-based, self-monitoring of VA. This may be particularly effective for patients living in peripheral areas with limited availability to medical services or patients with chronic or recurring eye diseases, reducing the need for formal, medical-staff-based VA testing during clinic visits and improving patient flow.
4. Discussion
Herein, we reported the development and validation of a novel near visual acuity (VA) card test that enables self-monitoring against two gold-standard charts. The main distinctive features of this card are the decimal units that are displayed next to each row, which facilitate the conversion of near VA test results into their distance equivalents; the additional lines compared with the standard cards, especially for the smaller-sized numbers that correspond to better VA; and the flow chart that guides the patients in the self-administration of this test.
The HSVA test showed good test–retest reliability, accuracy, and agreement of the VA assessments with the near RPVS values. These results are consistent with previous studies that reported similar distributions of Jaeger scores and mean LogMAR equivalents between the standard Jaeger test and a new near method (Philippine peso bill) [
23]. A recent systematic review of 17 publications that included studies on 13 different digital tools provided a current overview of digital tools for remotely assessing visual function that can be used without assistance of a healthcare professional and evaluated their accuracy. A low mean difference between digital visual acuity assessments and reference charts was reported, suggesting clinical equivalence [
20].
In the current study, the HSVA test demonstrated a moderate correlation with the distance Snellen chart results, and it also demonstrated that the self-test in this card could accurately predict the distance Snellen VA results. These findings are supported by a previous study showing a high correlation between the VA measured with the near vision digital self-test and the office Snellen acuity test [
3]. Wolffsohn and colleagues reported a high correlation between the distance VA measured with the distance Bailey–Lovie chart and the near VA measured by the near Bailey–Lovie chart, and the Practical Near Acuity Chart (PNAC), which uses a single paragraph with three simple related words on each line, especially when the patient did not have ocular pathology and the test was performed with high contrast [
11]. A similar conclusion was reported by another study that showed good repeatability when comparing distance visual acuity with near visual acuity with a small difference (of half a line) [
24]. These results indicate that it is feasible to use a near VA test and extrapolate its results to distance VA.
A key finding of this study was the high correlation between self-test VA by the HSVA and the results obtained by a masked ophthalmic technician. The new HSVA test card was designed to enable patients to self-assess their visual acuity and detect any significant changes that require urgent consultation with an ophthalmologist. Chen and colleagues recently reported an ICC of 0.94, indicating a strong positive correlation between at-home VA measured with the Accustat
® near vision digital self-test and the office Snellen test [
3]. Similar findings were found even when patients performed self-testing on an ETDRS chart compared with an in-office test [
25]. Xian et al. also reported a good agreement between a mobile-application-based VA self-test program and conventional VA tests [
26]. Another web-based test was also found to be a valid tool for remotely assessing VA, even when performed independently by patients at home [
17]. Even when performing the VA test on a smart TV, there were non-significant VA differences compared with a standard ETDRS test, suggesting that it can be used for accurate VA self-assessment in telemedical settings, both in normal and low-vision patients [
19]. A systematic review concerning the utilization of digital instruments for VA assessment revealed a diminished accuracy in digital self-assessments [
20]. However, Thirunavukarasu and colleagues conducted an extensive review, concluding that remote self-administered VA tests show potential benefits. They suggest that further pragmatic trials are necessary to substantiate their implementation in specific contexts, which could enhance the utility of these tests for patient-led or non-specialist assessments. Such deployment could significantly contribute to teleophthalmology, facilitate non-specialist eye evaluations, improve pre-consultation triage, and support autonomous, long-term vision monitoring [
12].
The overall high agreement between the HSVA self-test results and the results obtained by the masked examiner suggests that the instructions provided on the back of the card in simple language, along with basic guidance from a clinician at the clinic, allows the self-tested patients to obtain valid results. Near VA methods can facilitate self-monitoring of VA even if there is a discrepancy of one or two lines or 4–7 letters between the self-test results and the results measured by the examiner or the distance test [
2,
3,
25]. Though HSVA performance may vary across age groups, particularly among the elderly or those with potential access issues to in-person testing, similar results were obtained when the analysis was performed stratified by age groups.
Self-administered VA tests like the HSVA enhance patient engagement by allowing frequent at-home monitoring, which is beneficial for early detection of vision changes and timely intervention. These tests streamline the clinical workflow by providing preliminary VA data, aiding in prioritizing and efficiently planning patient care. Contrary to replacing clinician assessments, they supplement them, serving as an additional data point for a more informed and collaborative approach to patient care, thus improving overall outcomes.
Based on the correspondence between near and distance VA, several tools for near VA assessment have been developed for clinical use [
27], including apps for self-measurement of VA [
28] and a self-test card [
29], and their results have been found to be suitable and effective for monitoring changes in VA. Hence, the HSVA, which demonstrated consistent results with good repeatability, and was tested in the current study on patients from tertiary ophthalmology clinics, including patients with various eye pathologies, could serve for self-monitoring to detect changes in VA, particularly in patients with chronic eye diseases that are under recurrent treatment (such as patients receiving repeated intravitreal injections of anti-VEGF medications). The HSVA simplifies the use of the self-VA test with written and videotaped instructions and additional lines in the better-VA-sized numbers, and the decimal units next to each row ascribe this test several advantages that do not exist in other printed VA cards.
One of the limitations of this study is the fact that it was developed as a printed version rather than a digital one. In an era where there are emerging technologies for digital tests and smartphone-based applications to assess visual acuity, it might seem more natural to create another digital tool. However, there are populations that are technologically challenged, such as elderly people with chronic eye conditions, or populations who do not own smartphones due to economic or religious reasons. Thus, to avoid bias and the exclusion of potential populations and to maintain the simplicity of the test, it was developed as a non-digital version. Furthermore, as long as the self-administered at-home test follows a standardized protocol, it is equivalent to a standard technician-administered VA test in a clinic in the examined population [
2]. There is a broad agreement that both smartphone apps and printable materials assessing VA are easy, intuitive to use for patients, and reliable for clinicians [
16]. Investigating the feasibility of remote testing and its value in enhancing patient convenience and healthcare accessibility, future research is setting up a framework for the remote application of the HSVA test. Moreover, a direct comparison of the HSVA with digital devices would provide valuable context and evidence of the HSVA’s utility.
Additionally, although the Early Treatment Diabetic Retinopathy Study (ETDRS) chart is regarded as a more reliable measure, the present study employed the Snellen chart for comparative purposes. This approach is customary in the validation of novel VA charts, where the Snellen chart is utilized as a reference [
12]. Furthermore, despite the absence of a standardized protocol for employing Jaeger notation in contemporary near reading cards [
30], this metric was adopted due to its continued clinical acceptance and widespread use in numerous countries for daily visual assessment [
23].
Another limitation of the HSVA chart is its moderate correlation with standard distance VA tests. Ideally, a high correlation would suggest that these tests could serve interchangeably, offering a clinically practical, patient-operable alternative to traditional distance VA assessments. However, the HSVA is designed to supplement, rather than supplant, existing distance VA evaluations. Notably, the HSVA demonstrates a very strong agreement with the RPVS, underscoring its efficacy in near VA screening. This strong concordance highlights the HSVA’s capacity to detect significant VA changes in home monitoring, thereby prompting patients to seek a comprehensive examination when necessary.
However, this study aimed to demonstrate a good agreement between the HSVA and the widely accepted near test with the RPVS, as well as a close similarity between the self-test results and the results obtained at the clinic. Accuracy was indeed identified in these two parameters, suggesting that substantial VA changes (>two ETDRS lines) would be identified by both the near and the far test [
18]. Finally, self-administered VA tests may extend their utility beyond the field of ophthalmology, finding relevance in primary care, emergency medicine, and neurology. Further investigation is warranted to delineate the feasible applications of remote VA assessments. While in-person evaluations remain paramount for exhaustive ophthalmological examinations, remote VA testing could enhance healthcare delivery and alleviate pressures on constrained clinical resources, particularly when integrated with other nascent digital health technologies. Validated self-administered VA tests hold promise in enhancing teleophthalmology services, facilitating pre-consultation triage, enabling long-term visual monitoring, and supporting the assessment and documentation of ocular conditions by non-specialists.