Non-ophthalmic trials in oncology, endocrinology, CNS disorders, and rare disease frequently rely on ocular safety endpoints, but most research sites don't routinely provide eye care and lack the specialty staff to deliver it. That gap turns a routine safety assessment into a logistics problem that can delay a trial. Point-of-need mobile eye exams close that gap by bringing ophthalmic staff and equipment directly to the site or the participant, instead of asking either to travel to find them.
Why Do Non-Ophthalmic Trials Need Ophthalmic Safety Assessments?
Eye exams are often a crucial component of ocular endpoints in clinical trials, particularly when visual acuity, retinal imaging, visual field testing, or other ophthalmic safety measures serve as primary or secondary endpoints. Oncology, endocrinology, CNS disorders, and rare disease studies are just a few examples where ongoing ophthalmic assessments are needed to monitor safety, visual function, and potential vision loss in alignment with FDA expectations, whether or not the investigational treatment itself targets the eye.
What Barriers Do Sites Face Providing On-Study Eye Exams?
Most PIs and their sites don't routinely provide eye care, which makes finding a qualified specialist a logistics problem for site staff and a more complicated experience for participants. Any complication with that outside provider puts the trial at risk of delay. Barriers can include long wait times at specialist offices and limited pediatric access, since there are relatively few eye care providers nationwide equipped and experienced to examine young children.
An assessment conducted by 20/20 Onsite found that patients in several New England counties faced long wait and travel times for certain eye exams. In some communities, a retinal specialist capable of performing OCT and other retinal imaging modalities was over 100 miles away and often the only one serving patients in the area. That concentration extends wait times even when something urgent comes up, since everyone is routed to the same practice. If routine eye exams are difficult to schedule for the general population, they're equally difficult for participants already enrolled in a trial.
How Convenient and Efficient Is Point-of-Need Safety Testing?
Safety evaluation is central to every stage of drug development, but it plays a particularly visible role in Phase 1 trials, which focus on testing safety rather than merely monitoring it. Ophthalmological safety testing may be required under Phase 1 protocols, regardless of whether the investigational treatment targets the eye, since low- and non-intervention eye assessments can reveal subtle changes indicative of retinal, vascular, immune, and digestive system health effects.
20/20 Onsite recently supported a Phase 1 clinic conducting safety eye exams to monitor ocular side effects from an investigational drug for an infectious liver disease treatment. The CRO running the trial had an in-house Phase 1 clinic but lacked the specialty staff and equipment to conduct and review ophthalmologic assessments on-site. Rather than relying on relationships with local providers, the CRO brought in 20/20 Onsite's on-site Mobile Clinical Suite (MCS), placing comprehensive ophthalmologic evaluation and imaging capability roughly 100 feet down the hallway from the exam room.
The approach reduced the risk and inconvenience of sending participants off-site while tightening communication between site staff and the vendor. As the principal investigator put it: "While working with 20/20 Onsite for previous and current studies, we have been able to provide ophthalmological services that were previously not feasible for our clinical units. Doing so has been very successful in providing safety and ophthalmological oversight of study participants, as required by good clinical practices and the sponsor protocol. In providing onsite ophthalmology services for our volunteers, we find that we can draw from those that may not have access to stable transportation and feel like we are able to provide a more diverse group of subjects for our research studies."
Point-of-need assessments reduce the burden on both sides: participants don't have to leave the site for an eye exam, and study staff get a trusted partner to manage exam scheduling and study data. Sites also avoid purchasing new ophthalmic equipment, letting sponsor investment stretch further.
How Does 20/20 Onsite Speed Up Data Review and Turnaround?
Sites typically review and manually translate data from local ophthalmologists into their EDC, since the local specialist's exam form rarely mirrors the EDC's data fields. 20/20 Onsite offers exam forms customized to a study's specific data-entry fields, which streamlines the translation and protects study data quality. On-site optometrists and ophthalmic technicians assess participants directly while engaging ophthalmologists remotely for image review. Because reviews stay within 20/20 Onsite's own network, expedited turnaround from respected ophthalmologists is available when a site needs results fast, alongside standard submission to preferred reading centers.
To confirm data accuracy, 20/20 Onsite ran an observational study comparing mobile and in-office exams: 20 subjects aged 18 through 60 received autorefraction, keratometry, and subjective refraction testing in both settings within a 30-minute window, yielding 10 data points per eye across 40 unique eyes, for a total of more than 400 data points for comparison. The study concluded that mobile eye evaluations yield results as accurate as in-office exams, supporting data validation and reducing variability in endpoint measurements such as visual acuity and retinal imaging.
How Much Participant Burden Do Point-of-Need Assessments Remove?
Clinical sites often lack convenient access to eye care, so participants are sent off-site, which means coordinating travel and working around another office's schedule. Extra appointments and off-site travel discourage participation and raise the risk of delays or dropout.
20/20 Onsite's point-of-need model removes most of that burden. Participants receiving care aboard a Mobile Vision Clinic travel an average of 13 miles, compared to a 67-mile one-way trip reported in a recent study of clinical trial participants generally. That difference is the gap between a routine visit and a trip that competes with a participant's work schedule, transportation access, and willingness to stay enrolled.
What Point-of-Need Delivery Models Are Available for Ocular Endpoints?
20/20 Onsite offers three delivery models for trials with ocular endpoints, each staffed by clinicians trained in ophthalmology, clinical trial operations, regulatory-aligned data collection, and standardized endpoint capture:
- Mobile Vision Clinics (MVC): Retrofitted vehicles built as full optometry clinics, bringing assessments and clinical trial visits directly to participants.
- Mobile Clinical Suites (MCS): Pop-up eye clinics installed inside an existing clinical site, so participants never have to leave the building for an eye exam.
- Mobile Vision Pods (MVP): Flexible, semi-permanent standalone clinics suited to trials with intense visit schedules.
Each model gives participants temporary access to optometry services and can extend a trial's geographic reach into areas without accessible vision care, all without asking a site to purchase or staff new equipment.
If your trial has ocular safety endpoints, whether or not the treatment itself targets the eye, request a protocol review for a custom delivery plan.
Frequently Asked Questions
Why do non-ophthalmic clinical trials need eye exams? Many non-ophthalmic trials, including oncology, endocrinology, CNS, and rare disease studies, use ocular safety endpoints to monitor visual function and detect early signs of systemic effects, such as retinal, vascular, immune, or digestive system changes. These assessments are required by protocol regardless of whether the investigational treatment targets the eye.
What barriers do research sites face when scheduling on-study eye exams? Most sites don't provide eye care in-house, so they rely on outside specialists, which introduces wait times, travel burden, and scheduling risk. In some regions, a single retinal specialist capable of performing OCT imaging serves every patient in the area, extending wait times even for urgent needs.
How much travel burden does a mobile vision clinic remove for trial participants? Participants receiving care aboard a 20/20 Onsite Mobile Vision Clinic travel an average of 13 miles, compared to a 67-mile one-way trip reported in a recent study of clinical trial participants generally.
Is data collected via mobile eye exams as accurate as in-office testing? Yes. An observational study comparing mobile and in-office exams across 20 subjects and 40 eyes, yielding more than 400 data points, found that mobile eye evaluations were as accurate as in-office examinations.
What's the difference between a Mobile Vision Clinic, a Mobile Clinical Suite, and a Mobile Vision Pod? A Mobile Vision Clinic is a retrofitted vehicle that travels directly to participants. A Mobile Clinical Suite is a pop-up eye clinic installed inside an existing clinical site, so participants don't leave the building. A Mobile Vision Pod is a flexible, semi-permanent, standalone clinic suited for trials with intensive visit schedules.
Does adding on-site ophthalmic support require a site to buy new equipment? No. 20/20 Onsite's mobile solutions bring specialty ophthalmic equipment and trained staff, so sites don't need to purchase new equipment to participate in a trial requiring ocular endpoints.
How does 20/20 Onsite speed up ophthalmic data review for sites? 20/20 Onsite provides exam forms customized to a study's EDC fields, reducing manual translation work, and can request expedited image review from ophthalmologists within its own network when a site needs faster turnaround than standard reading center submission.