Remote Functional Monitoring in clinical trials: An Exploration of At-home Perimetry

Executive summary

At-home perimetry enables a transition from episodic, resource-intensive visual field snapshots to high-frequency, trend-based progression analytics. It offers:

• Increased data density with reduced test-retest variability

• Earlier detection of visual field progression slopes

• Potential statistical power gains and sample size efficiencies through noise reduction

• Potential per-patient cost savings (reduced site visits, technician time, and monitoring requirements)

• Improved patient retention in long-duration studies

• Possibility for hybrid and decentralized trials without compromising endpoint robustness

This report summarises feasibility data from a technical evaluation by a Pharma company and PeriVision and outlines the operational, statistical, and regulatory implications for ophthalmology trials.

Introduction

The clinical validation of novel ophthalmic therapies has historically relied upon anatomical biomarkers, yet there is a profound and growing consensus among clinicians, researchers, and regulatory bodies that functional endpoints are the true arbiters of patient-centered benefit. In conditions such as glaucoma, diabetic retinopathy, and geographic atrophy, the primary therapeutic objective is the preservation of vision, a goal that structural imaging alone cannot fully quantify.¹ Best-corrected visual acuity (BCVA) has long served as the industry’s "gold standard" primary endpoint; however, it is increasingly recognized as an insensitive measure for early-stage neurodegeneration or peripheral visual field loss, which often compromises patient quality of life long before central vision is impacted.²

The importance of functional vision - defined as the ability to interact effectively with the visual environment - extends beyond the physiological measurements of the eye. It encompasses orientation, mobility, facial recognition, and the performance of activities of daily living (ADL).¹ Standard clinical tests like perimetry capture the "hill of vision," providing an objective map of light sensitivity across the retina. This functional map correlates significantly more closely with a patient’s subjective experience of their disease than structural measures like retinal nerve fiber layer (RNFL) thickness or lesion volume on Optical Coherence Tomography (OCT).¹ For instance, in diabetic retinopathy, functional changes such as impaired dark adaptation or reduced flicker sensitivity often precede observable vascular abnormalities on fundus photography, suggesting that functional monitoring may offer a more sensitive "early warning system" for disease progression.³

The current report explores the transition toward remote functional monitoring through a detailed case study of the collaboration between a Pharma company and PeriVision. By leveraging PeriVision’s wearable eye testing platform combining virtual reality (VR) headsets  and artificial intelligence (AI) algorithms, they explored approaches to overcome the systemic bottlenecks of traditional perimetry and enable high-frequency data collection aligning with modern decentralized clinical trial (DCT) frameworks. The following analysis evaluates the technical feasibility, regulatory implications, and preliminary results of this transformative approach.

Challenges with standard perimetry in clinical trials 

The current paradigm of ophthalmic clinical trials is characterized by a heavy reliance on centralized, site-based testing. While this ensures a high degree of control over environmental variables, it introduces significant operational bottlenecks and data limitations that can jeopardize the success of long-term studies.

Stationary workflows and infrastructure bottlenecks

Traditional perimetry is conducted using stationary bowl perimeters, e.g. the Humphrey Field Analyzer (HFA) or Octopus 900. These devices weigh c. 25 kg and require dedicated clinical space that must be completely darkened to ensure standardized background luminance.⁴ This stationary requirement creates a significant "room bottleneck". Hospitals and clinics, already facing severe capacity constraints, must allocate specific real estate that cannot easily be used for other examinations.⁵

Furthermore, standard perimetry is resource-intensive regarding human capital. Each test typically requires a dedicated technician / assistant to position the patient, provide instructions, and monitor for fixation losses and fatigue over a period that can range from 10 to 30 minutes per eye.⁴ This staffing requirement is a major pain point, as over 90% of hospital leaders report staffing shortages as a primary barrier to patient flow and throughput.⁶ In the context of a clinical trial, the need for certified technicians at every site increases operational complexity and costs significantly.

Participant recruitment and data variability

The centralized nature of testing acts as a barrier to recruitment and trial diversity. Patients must travel to specialized centers for testing, a burden that is particularly acute for the elderly, individuals with significant visual impairment, or those living in rural areas.⁴ This logistical hurdle often leads to a participant pool that lacks geographic and socioeconomic diversity, potentially limiting the generalizability of trial results.⁵

Moreover, the infrequency of on-site testing - often occurring only every 3 to 6 months - results in a "snapshot" model of disease monitoring. Visual field testing is notoriously prone to high intrasubject variability; factors such as the time of day, patient alertness, and the "learning effect" (where performance improves as the patient becomes more familiar with the test) can lead to noise that masks true disease progression.⁴ Statistical literature suggests that 10% to 45% of standard visual field tests are unreliable, necessitating repeat testing and further straining clinical resources.^7,8

Patient fatigue and cognitive load

Standard automated perimetry (SAP) requires the patient to maintain steady fixation on a central point while responding to brief flashes of light in the periphery. This task is cognitively demanding and physically uncomfortable. Prolonged testing sessions in a dark room induce fatigue and concentration lapses, which manifest as increased false-positive and false-negative rates.⁴ For patients with advanced disease, the test can be particularly discouraging, as they may perceive few stimuli, further impacting their motivation and the reliability.⁹

Constraint	Traditional perimetry	Clinical trial impact
Equipment	25 kg stationary device 4	Requires dedicated site space and dark rooms 5
Staffing	1:1 technician-to-patient ratio 4	Major operational bottleneck; high labor cost 6
Logistics	In-person center visits required 4	Limits recruitment diversity and patient retention 10
Data Density	Periodic "snapshots"4	High variability; progression obscured by noise 11
Patient Experience	15-30 min. duration per session 4	High fatigue; 10-45% results are unreliable 7,8

Potential of remote testing and DCTs

Wearable perimetry represents a fundamental shift in how visual function is assessed, moving the testing environment from the clinic to the home. This decentralization addresses core bottlenecks of traditional workflows while providing a richer, more reliable dataset.

Benefits for diversity and patient retention

DCTs leverage digital tools, telemedicine, and wearable devices to increase patient accessibility.¹⁰ By removing the need for frequent travel, wearable perimetry allows a more diverse and representative patient population to enroll in studies, particularly those with mobility issues or rare diseases who may find traditional center-based visits prohibitive.¹⁰ It may also increase the potential to include patients from rural areas, which may be key in some settings, e.g. in the US. The reduction in participant burden directly correlates with improved patient retention and engagement, as testing can be integrated into the patient’s daily routine.⁵ 

Such decentralized testing in turn also translates into a lower number of site visits required, lower per-visit operational costs, and a potential reduction in on-site monitoring burden.

High-frequency data and trend analysis

One of the most significant advantages of remote monitoring is the ability to conduct high-frequency testing. Instead of relying on a single data point every few months, researchers can collect weekly or even daily measurements in the patient’s natural environment.⁴ This abundance of data allows for robust "de-noising" through trend analysis. By evaluating the slope of mean deviation (MD) over time, researchers can differentiate true disease progression from random fluctuation with much greater confidence.⁴ Studies have shown that eyes experiencing rapid visual field MD slopes over a two-year period are ten times more likely to reach FDA-accepted endpoints, suggesting high-frequency monitoring could significantly shorten trial durations and accelerate drug development.¹² Additionally, less variable data also allows for sample size optimization, whereby reduced variability translates into improved statistical power and potential sample size efficiencies.

Regulatory pathways (FDA and EMA)

The regulatory landscape for functional endpoints is evolving, with both the FDA and EMA showing increasing openness to novel methodologies that demonstrate clinical relevance to the patient’s life.

FDA framework

The FDA’s Center for Drug Evaluation and Research (CDER) evaluates visual function through parameters like visual fields, visual acuity, and contrast sensitivity.¹¹ Historically, the agency has accepted intraocular pressure (IOP) as a surrogate endpoint for glaucoma therapies, but it is now actively seeking validated structural and functional endpoints that can retard disease progression.¹¹ For a new functional endpoint to be considered "approvable," it must demonstrate a strong correlation - ideally an R^2 = 0.9  - to current or future visual function.¹¹ The agency prioritizes measurements that are reproducible, consistent, and less variable than current standards, while emphasizing that the change must be clinically significant in a real-world context.¹¹

EMA perspective

In the European Union, the EMA often places a stronger emphasis on functional endpoints over purely anatomical markers, particularly in the context of Health Technology Assessments (HTA).¹³ EMA requires rigorous validation of any new endpoint, including data on test-retest reliability and the percentage of patients expected to experience a clinically relevant benefit.²² Recent initiatives like the "BRIDGE" workstream are attempting to harmonize these clinical endpoints across global health authorities to ensure that European patients do not experience delays in accessing innovative therapies compared to other regions.¹³

Reimbursement and HTA implications

The clinical utility of robust functional data extends beyond regulatory clearance, serving as a critical determinant in Health Technology Assessments (HTA) and subsequent reimbursement negotiations. While regulatory bodies like the FDA may accept anatomical surrogates if a strong structural-functional relationship, HTA agencies -  such as Germany’s Federal Joint Committee (G-BA) and France’s High Authority for Health (HAS) -  prioritize "patient-relevant benefit," which is primarily demonstrated through documented improvements in morbidity, symptoms, and health-related quality of life. In the absence of definitive functional data, therapies often receive "no added benefit" ratings, leading to restricted market access or reference pricing that fails to reflect a therapy's clinical innovation.¹⁴

A prominent example of this regulatory and reimbursement divergence is seen in the case of pegcetacoplan (Syfovre) for geographic atrophy (GA). While the FDA granted approval based on the anatomical endpoint of reduction in GA lesion area,¹⁵ the EMA repeatedly issued a negative opinion, confirmed in late 2024.¹⁶ It concluded that although the therapy successfully slowed lesion growth, this did not translate into a "clinically meaningful benefit" for patients' everyday functioning, ultimately determining that the anatomical preservation did not outweigh the safety risks associated with regular intraocular injections.¹⁷ Conversely, voretigene neparvovec (Luxturna) successfully achieved high HTA ratings and premium reimbursement by utilizing the endpoints full visual field stimulus threshold testing, visual acuity (ETDRS / HOTV chart) and “light sensitivity via multi-luminance mobility test” (a novel endpoint developed to measure a patient’s ability to navigate obstacles under standardized light levels simulating real-world environments).^{18, 19} This evidence of tangible functional improvement led to a "considerable added benefit" rating from the G-BA and an "Important SMR / ASMR II" rating from the HAS, supporting a reimbursement price of EUR 280,000.¹⁸ These cases underscore that high-frequency, reliable functional data is essential not only for proving efficacy but for securing the commercial value of ophthalmic innovations.

Results of technical exploration by a Pharma company and PeriVision

The collaboration between a Pharma company and PeriVision was structured as a multi-phase technology evaluation to validate the usability and reliability of wearable perimetry in a clinical trial context. This exploration utilized the VisionOne platform, which combines commercial VR hardware with proprietary AI-optimized testing strategies, such as the SORS algorithm.

SORS: AI-enhanced perimetry

The Sequentially Optimized Reconstruction Strategy (SORS) is an AI-based meta-strategy developed to minimize test duration without compromising accuracy.²⁰ SORS utilizes machine learning algorithms trained on thousands of visual field tests to identify an optimal "testing path." By evaluating a specific subset of test locations (e.g., 20 or 36 points), the system can reconstruct the untested locations using linear approximation and learned correlations between retinotopic locations.²⁰

Clinical studies have shown that SORS can reduce acquisition time by up to 70% compared to standard dynamic strategies.²⁰ In a validation study of 83 subjects, SORS achieved a high correlation with the HFA gold standard, with MD correlation values of R = 0.88  for only 20 tested locations and R = 0.912 for 36 locations.⁴ Furthermore, SORS demonstrated superior test-retest reliability compared to traditional methods, as its standard deviations for repeat measurements were smaller than those of the standard dynamic strategy.²¹

Phase 1 results

Phase 1 (October 2024 to April 2025) primarily focused on testing the feasibility and user experience (UX) among 42 healthy subjects, incl. 10 conducting tests in a home setting.⁴

User experience (UX) survey data

The qualitative feedback was exceptionally positive, indicating high levels of acceptance:

• Ease of use: 92.6% found the VR-based test easy to use (mean rating 4.6/5).⁴

• Clarity of instructions: 90.7% found the instructions easy to understand (mean rating 4.8/5).⁴

• Time burden: 77.8% found the test duration not bothersome (mean rating 4.3/5).⁴

• Overall experience: 96.3% rated their experience as "Very good" or "Good".⁴

Furthermore, participants expressed a strong willingness for frequent use if recommended: 44.4% were willing to test twice per week, and 29.6% were willing to test daily.⁴

UX metric	Survey result (%)	Mean rating (1-5)
Ease of Use	92.6% 4	4.6 4
Clear Instructions	90.7% 4	4.8 4
Test Understanding	98.1% 4	4.9 4
Acceptance of Time Required	77.8% 4	4.3 4

Statistical reliability and repeatability

The Phase 1 results validated the platform’s high degree of repeatability. The mean test-retest variability for both Mean Sensitivity (MS) and Mean Defect (MD) was recorded at 0.78 dBs.⁴ This is significantly lower than the 1.71 dBs to 1.77 dBs typically reported for HFA’s SITA strategy.⁴ The mean "maximum difference" across all tests for each participant was 1.46 dBs.⁴

The Intraclass Correlation Coefficient (ICC) was 0.70. While traditionally interpreted as moderate reliability in heterogeneous cohorts, the ICC is inherently dependent on between-subject variance. In a healthy, homogeneous cohort, where sensitivity values cluster tightly near normal, between-subject variability is necessarily restricted. Because the ICC is defined as the ratio of between-subject variance to total variance (between-subject + within-subject), restricted range will reduce the ICC even when absolute measurement error is low. It is therefore noteworthy that healthy-cohort repeatability studies of conventional automated perimetry typically report absolute test-retest variability metrics (e.g. standard deviation) rather than ICC values, reflecting the well-recognized dependence of ICC on population heterogeneity.

Accordingly, the within-subject test-retest standard deviation (0.78 dB) provides a more direct and clinically relevant estimate of measurement precision in this early-phase study. Importantly, for longitudinal slope-based progression analyses, statistical power is determined primarily by within-subject variability rather than ICC magnitude. The low variability observed here translates into substantially shorter projected progression-detection timelines. For example, assuming α = 0.05 and 80% power for within-arm slope detection, weekly at-home testing (0.78 dB SD) would allow detection of a moderate progression rate (-1.0 dB/year) in approximately 12 to 15 months, compared with over 50 months under quarterly clinic testing (1.7 dB SD).

Future technical roadmap

A recent review evaluating functional endpoints in geographic atrophy noted that there is mounting evidence for the utility of functional assessments beyond BCVA that provide a more robust indication of the functional impact of new therapies.⁸ In this context, PeriVision is developing a "Fixation-Independent Perimetry" (FIPR) algorithm for patients with advanced retinal diseases like Geographic Atrophy (GA) or Age-related Macular Degeneration (AMD).⁴ Traditional perimetry is often non-viable for these patients due to their inability to maintain central fixation. By combining VR, eye tracking and AI, FIPR unlocks functional testing beyond glaucoma (e.g. neuroprotection trials) to previously unmeasurable populations such as geographic atrophy, early diabetic retinopathy functional impairment, rare retinal dystrophies, post-intervention monitoring in gene therapy, providing critical insights into treatment efficacy.⁴

Conclusion

This technical exploration demonstrates that wearable perimetry is not only a feasible alternative to stationary testing but also a necessary evolution for the modernization of clinical trials. Traditional perimetry is constrained by significant infrastructure, staffing, and bottlenecks that limit the density and reliability of functional data. Wearable systems address these challenges by providing a portable, technician-free platform that can be deployed at scale in the home environment. This makes it perfectly suited to optimise different trial phases, e.g. phase II dose-finding (trend sensitivity), long phase III progression studies, or post-marketing real-world evidence.

The preliminary results from the Phase 1 feasibility study are highly encouraging. With a mean test-retest variability of 0.78 dBs, the VisionOne platform demonstrates absolute repeatability that exceeds that of the current clinical gold standard. When combined with AI strategies like SORS, which reduces test time by up to 70%, the technology effectively mitigates patient fatigue and the cognitive load that often compromises data integrity in stationary settings.When combined with AI strategies like SORS, which reduces test time by up to 70%, the technology effectively mitigates patient fatigue and the cognitive load that often compromises data integrity in stationary settings. In this way it can enhance the reproducibility and clinical relevance of the data - a critical prerequisite for satisfying FDA and EMA expectations around reproducibility, clinical relevance, and slope-based progression metrics in trials.

From a strategic perspective, the transition to high-frequency remote monitoring may reduce trial risk and accelerate signal detection, while offering significant benefits for recruitment diversity and participant retention. While regulatory and reimbursement landscapes continue to evolve, the increasing recognition of functional endpoints as primary indicators of patient quality of life creates a robust pathway for the integration of wearable perimetry into pivotal ophthalmic trials. The future of ophthalmic drug development will likely depend on such integrated, patient-centric monitoring solutions to provide the high-quality, real-world evidence required by both health authorities and payers.

Picture: product demo at the Roche Creasphere EXPO DAY in Basel.

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