High Density, Low Availability: Rethinking Ophthalmic Trial Readiness

Ophthalmic assessments are no longer mere box-checks in clinical trials. With advanced imaging and endpoints becoming the norm, sponsors must grapple with complexity and risk that extend well beyond traditional site selection. Adding to these challenges are so-called “eye care oases,” states or regions believed to have a wealth of eye-care providers but which, in reality, lack the capacity needed for rigorous research.

According to the Bureau of Labor Statistics (BLS), states like Florida, California, and Texas boast some of the country's highest concentrations of ophthalmology professionals. Yet sponsors repeatedly find that the mere presence of practitioners does not translate into research availability at sites. Why? Advanced ophthalmic assessments demand more than a license to practice; they require specialized equipment, availability, and an operational framework to ensure data quality.

Note: While these states boast high numbers of specialists, the ophthalmology shortage is a nationwide crisis. 

The Myth of the Eye Care Oasis: Care Deserts Aren’t Just Rural

Traditionally, we think of eye care deserts as sparsely populated regions—places like the far corners of North Dakota or the rural Southwest. However, sponsors quickly learn that even high-density states can become deserts for advanced clinical trials. Here are just two examples where 20/20 Onsite is routinely deployed to provide advanced, point-of-need ophthalmic clinical trial solutions:

• Florida:
  Cited by the BLS as having one of the highest concentrations of ophthalmologists, yet many practices focus on routine care and potentially have minimal bandwidth for research protocols.
  
  
• Texas & California:
  Boast massive populations and significant numbers of ophthalmologists, but these professionals are often spread across large geographic areas or clustered in metropolitan pockets. Sponsors compete fiercely for a handful of truly “research-ready” clinicians.

High Density Doesn’t Mean High Availability

Data from the BLS might show a flourishing number of practitioners, but that statistic alone can be misleading in a clinical research context:

4. Competition Among Sponsors
Increasing numbers of ophthalmology-focused clinical trials mean sponsors are vying for the same finite pool of experienced investigators. Without a compelling plan for operational and financial support, a sponsor can easily lose out to competitors offering streamlined processes or equipment budgets.

Optometrists vs. Ophthalmologists: The Equipment Gap

Looking at the Bureau of Labor Statistics data for Optometrists and Ophthalmologists side by side often reveals a surprising increased density of optometrists across the U.S. But density alone doesn’t solve the issue of specialized equipment. While optometrists offer valuable front-line eye care:

• They may not have the advanced diagnostic tools needed for intricate trial endpoints.
  
  
• They typically refer out for complex testing or image reading (OCT, ERG, VEP, or high-end imaging).
  
  
• Pediatric ophthalmology is particularly underrepresented, making any pediatric-focused trial especially challenging.
  
  

This doesn’t diminish the role optometrists can play—particularly in large screening efforts or more routine ophthalmic assessments—but it underscores how simply having “an eye professional” in the area doesn’t guarantee the infrastructure required for robust data collection.

Turning a Desert into a Genuine Oasis

With a clear understanding of the complexities, sponsors can adopt strategic measures to ensure that even high-density, high-demand areas become reliable research hubs.

1. Leverage Mobile, Point-of-need Ophthalmic Solutions

Mobile units equipped with fundus cameras and OCT, and staff trained to operate them, can bring specialized diagnostics to any site on demand. This approach:

• Reduces logistical burdens on participants (less travel to specialized centers). For example, 20/20 Onsite has shown to reduce the average travel of patients by 82%.
• Ensures consistency in equipment and data collection across multiple sites.
  
  

• Allows sponsors to expand into regions previously deemed “lacking” in resources.

2. Partner with Specialized Vendors

Teams focusing exclusively on ophthalmology bring niche expertise, from equipment procurement to technician training and patient scheduling. This can drastically reduce a sponsor’s overhead, especially for:

• Setting up centralized reading centers and creating imaging guidelines.
  
  
• Calibrating assessment devices correctly and routinely.
  
  
• Managing data pipelines to ensure standardized, high-quality results.
  
  

The Takeaway: A Nationwide Need

Don’t let the presence of a bustling ophthalmology community fool you into thinking your study will be simple to operationalize. There’s an undercurrent of unmet need everywhere, from rural plains to metropolitan corridors. And that need goes beyond having an “eye care professional on site.” High-complexity imaging, specialized staff certifications, and pediatric sub-specialties are not a given, even in states claiming to have the highest densities of providers.

Key Points to Remember

• Availability ≠ Capability: A licensed ophthalmologist might not have the advanced tools or time to run a specialized clinical trial.
  
  
• High-Density States Face High Demand: Wherever large numbers of eye-care professionals exist, there’s also large patient demand and intense sponsor competition.
  
  
• Optometrists Can’t Always Fill the Gap: While valuable for certain screening, they may lack the specialized imaging technology or certification standards required for complex endpoints.
  
  
• Mobile or Hybrid Models Are on the Rise: Sponsors increasingly partner with specialized vendors to bridge site gaps.
  
  

Moving Forward

As you plan your next clinical trial involving eye care endpoints, keep in mind:

1. Conduct a thorough site feasibility check: Conduct a deep dive into each site’s true capabilities—do they just have a “fundus camera " or a high-resolution, research-grade specific device? Are staff fully certified to use it?
   
   
2. Evaluate your protocol’s specific needs: Clinical operations personnel must appreciate the nuances of their study protocols, especially regarding ophthalmic assessments. Seemingly minor details, like the difference between basic and advanced equipment requirements, can balloon into major operational challenges. Use our free protocol audit guide.
   
   
3. Build partnerships early: Whether through academic centers, specialized private ophthalmology clinics, or point-of-need services, you’ll want to ensure you have the right equipment and staff from day one.
   
   

By recognizing that “eye care deserts” are not confined to remote areas—and that even high-density regions can pose significant challenges—you’ll be better prepared to identify gaps, secure the right resources, and ultimately run a smoother, more successful ophthalmic trial.

As the only provider dedicated to point-of-need eye exams for clinical research, 20/20 Onsite can help sponsors with their ophthalmic assessment needs. From protocol review to seamless site integration, our on-demand, point-of-need solutions have helped fast-track trials nationwide.

To discuss your upcoming trial, contact us here.