Early Detection For Future Trial Recruitment

Millions of older adults in the U.S. live with undiagnosed or unmanaged eye disease. Barriers such as limited mobility, transportation, and a lack of trusted providers often lead to delayed detection and preventable vision loss. These same challenges restrict the pool of eligible participants for clinical trials investigating sight-preserving and vision-restoring therapies, including treatments for geographic atrophy (GA).

A leading sponsor partnered with 20/20 Onsite to test whether community-based, point-of-need ophthalmic assessments could:

1. Surface previously undetected GA and other retinal pathology
2. Educate patients about their diagnosis and available therapies
3. Create a scalable pathway to future trial recruitment in similar populations

Over the course of two months, 20/20 Onsite conducted five mobile vision events in community settings, reaching 50 participants aged 46–92 (average age 75). Each visit included comprehensive ophthalmic assessments and personalized education on disease prevention, management, and GA awareness.

Diagnostic Protocol

• Optical Coherence Tomography (OCT)
• Retinal Imaging
• Dilated Fundus Exam
• Slit Lamp Biomicroscopy

Services were delivered via 20/20 Onsite’s point-of-need mobile care model, using state-of-the-art equipment and certified staff in community locations close to where participants live and gather.

Of the 50 individuals screened, 22% (11 participants) were referred for follow-up evaluation due to findings suggestive of previously undetected, potentially vision-threatening conditions such as glaucoma, AMD, diabetic retinopathy, and GA-related changes.

These outcomes underscore both:

• The prevalence of undiagnosed ocular disease in everyday community settings, and
• The power of point-of-need screening to surface at-risk patients before irreversible vision loss occurs.

Participants presented with a range of findings, including:

• Diabetes-related changes
• Elevated intraocular pressure (IOP)
• Reduced best-corrected visual acuity (BCVA)
• Drusen and Dry AMD
• Cataract
• Epiretinal membrane (ERM)
• Vitreomacular traction
• Glaucoma
• Macular edema
• C/D asymmetry

Expanded Access

Mobile screenings reached populations that may otherwise lack access to optometrists or ophthalmologists—helping to close gaps in preventive care.

Early Detection

22% referral rate demonstrates the power of proactive community-based screenings to identify disease early and connect patients to care.

Trust and Education

Face-to-face education built confidence and understanding around eye health, empowering participants to take the next steps in managing their vision.

Scalability

This pilot demonstrates the potential to scale similar initiatives nationally—especially in communities underserved by ophthalmic specialists—to improve health outcomes and strengthen future clinical research pipelines.

Although the sponsor of this initiative focused on screening, education, and referrals to local providers (rather than enrolling patients directly into a trial), the same model can be adapted to drive recruitment for other ophthalmic or safety-driven trials.

With minimal protocol adjustments, sponsors could:

1. Layer pre-screening for trial eligibility into community events
   1. Add inclusion/exclusion pre-screen questions alongside the clinical assessment.
   2. Flag patients with relevant pathology who meet high-level eligibility criteria.
2. Capture consent for research follow-up
   1. Ask interested, qualifying patients for permission to be contacted about clinical research opportunities.
   2. Build a registry of pre-qualified, engaged patients who already understand their diagnosis and the importance of treatment.
3. Route identified patients directly to trial sites or virtual pre-screening hubs
   1. Share de-identified summaries and, with consent, connect patients to nearby research sites.
   2. Use tele-ophthalmology or centralized reading centers to confirm eligibility faster.
4. Create a repeatable “sourcing engine” in priority geographies
   1. Replicate this model at senior centers, housing communities, and other high-yield locations.
   2. Systematically identify patients who are both clinically appropriate and already primed by education to consider trial participation.

Early detection doesn’t just preserve sight; it systematically identifies candidates for current and future clinical trials. By uncovering disease earlier and engaging patients in trusted community settings, point-of-need models like this can:

• Expand the pool of diagnosed patients
• Improve the quality of conversations about treatment and research
• Accelerate recruitment and increase diversity for sponsors studying retinal and systemic conditions

Because the engagement model is partner-agnostic and modular, it can plug into patient-facing programs run by sponsors, CROs, advocacy groups, or health systems. By teaming with trusted community organizations (e.g., senior centers, faith communities, housing communities), the same workflow can be deployed anywhere, which creates a scalable pathway from screening to potential trial enrollment.

This pilot shows what’s possible in a relatively small cohort. At scale, the same approach can power a national disease identification network, feeding both better patient care today and stronger research pipelines tomorrow.