For many sponsors, the full meaning of “ophthalmic assessments” might remain an afterthought until those requirements start complicating site setup, timelines, budget, or patient enrollment. Yet underestimating those seemingly small details can drive major downstream consequences and alter trial timelines.
Why does this matter? The risk associated with an improperly planned ophthalmic endpoint can reverberate through your study, leading:
- Inconsistent Data Quality: Variability in imaging quality and interpretation undermines the study’s integrity.
- Increased Protocol Deviations: Missed or misinterpreted requirements complicate site operations.
- Fulfillment Complexities: Diverse equipment and methodologies demand specialized training.
- Cost Overruns: Retrofitting assessments or repeating procedures increases expenditures.
Understanding the Complexity of Ophthalmic Assessments
Not all ophthalmic assessments are the same. The difference between a basic assessment (e.g., a quick screening with a handheld device) versus a highly specialized procedure (e.g., advanced imaging requiring a board-certified ophthalmologist review) can be enormous:
- Equipment Requirements: Basic devices vs. advanced equipment that produce higher-resolution images.
- Specialist Involvement: While a general optometrist or an ophthalmic technician might suffice for some exams, complex assessments may require board-certified ophthalmologist oversight with particular subspecialty experience or a reading center.
- Data Quality: Higher-tier assessments generally produce deeper datasets. They also require more rigorous training, compliance, and often more time from the patient and site.
When reviewing your protocol and seeing ocular requirements, alarm bells should ring: Do we have the right infrastructure to support this?
Real World Example: Fundus Photography
Many studies involve fundus photography to validate endpoints or monitor safety. However, the most commonly used exam camera in primary-care or basic eye-care settings may not deliver the same quality or breadth of imaging as advanced cameras in specialty practices. This matters if your trial protocol hinges on subtle ocular changes, especially in diseases where early detection is critical.
- Resolution Differences
- Basic fundus cameras might capture a standard retina view with limited resolution.
- Advanced cameras (often found in ophthalmology clinics or specialized mobile eye units) can detect nuances that could influence your endpoints.
- Dilation Requirements
- Some advanced cameras can capture peripheral images without dilation, while others need significant pupil dilation for best results.
- Dilation raises logistical questions: Who will administer the drops? Are you using a standard concentration or a stronger formula to keep pupils dilated longer? Do the dilation drops interact with the Investigational Product being tested? This isn’t a trivial add-on; it can affect patient comfort, screening efficiency, and adverse event reporting.
Key takeaway: The type of equipment alone can shift your study from “low-risk” to “complex,” requiring specialized partners, additional training, or site infrastructure upgrades.
With so many variables that might fall outside your expertise, we compiled these seven questions to ask when reviewing your protocol to avoid trial derailments!
Seven Protocol Questions: Why They Matter
Below are seven questions to help you gauge the complexity and risk of your trial’s ophthalmic requirements. Each question briefly explains “why we ask” and “what it means” for your protocol. Use this as a diagnostic tool to quickly audit and identify areas needing additional planning or specialized support.
Note: If you answer “I don’t know” to any of these questions, it’s time to investigate the protocol further. We review protocols daily and are happy to explain the complexities of your requirements.
1. Has one of the following ophthalmic assessments at screening?
- Visual Acuity or BCVA (Best Corrected Visual Acuity)
- IOP (Intraocular Pressure)
- OCT (Optical Coherence Tomography)
- Fundus Photo
- Dilated Fundus Exam
- Color Vision
- Slit Lamp Exam
- ERG & VEP
- Pupil Reflex Testing
Why We Ask
Performing any of these assessments at screening indicates that you need on-site equipment or relationships with specialized partners from the start. Early complexity can prolong screening times and increase costs, especially if sites lack these capabilities and require extra training or equipment procurement.
What It Means
Sponsors often underestimate the implications of even a “simple” ophthalmic screening. For instance, an OCT might demand higher-end imaging technology and specialized technicians. Screening complexities can also impact your enrollment timeline if certain sites or patient populations have limited access to these assessments.
2. Has one of these ophthalmic assessments on study?
- Visual Acuity or BCVA (Best Corrected Visual Acuity)
- IOP (Intraocular Pressure)
- OCT (Optical Coherence Tomography)
- Fundus Photo
- Dilated Fundus Exam
- Color Vision
- Slit Lamp Exam
- ERG & VEP
- Pupil Reflex Testing
Why We Ask
When assessments continue throughout the trial, their frequency and timing can affect patient retention, site workload, and overall costs. Repeated advanced imaging might require equipment recalibration at set intervals.
What It Means
Ophthalmic assessments performed on the same patient over time demand consistent data quality across multiple time points. You’ll need robust standard operating procedures (SOPs) to maintain consistency if you include serial OCT or repeated fundus photos. This can introduce added complexity in vendor oversight, site communication, and data monitoring.
3. Ophthalmic assessments require equipment certification: Yes / No
Why We Ask
Some ophthalmic devices—particularly those used for advanced imaging—require specific certifications or calibrations to meet regulatory and quality standards.
What It Means
If the equipment must be certified, you could face stricter regulatory hurdles and site readiness constraints. This often translates into additional site audits, training requirements, or dedicated partner relationships.
4. Ophthalmic assessments require staff certification: Yes / No
Why We Ask
Properly trained staff (optometrists, ophthalmologists, technicians) are crucial to collecting reliable data. Certification requirements might be protocol-specific or mandated by local regulations.
What It Means
If you need staff with specialized credentials, your site selection strategy becomes more targeted. You may need to recruit from a smaller pool of qualified professionals or partner with point-of-need partners that can supply certified personnel. This constraint can limit your site footprint and potentially extend startup times.
5. Non-Ophthalmology PI’s at private practice: Yes / No
Why We Ask
A Principal Investigator (PI) without ophthalmic expertise could miss critical nuances in conducting or interpreting advanced vision assessments.
What It Means
If your PI isn’t an ophthalmologist, they may need additional training or a consulting ophthalmologist to ensure protocol compliance and data integrity. This can also impact how quickly your site can react to adverse events.
6. The geography of some sites is outside urban city centers: Yes / No
Why We Ask
Site location can affect patient access to specialized equipment or trained eye-care professionals. Rural or suburban clinics may lack advanced imaging devices or immediate referral pathways to ophthalmologists. Even in urban areas, many ophthalmologist practices with advanced equipment are limited.
What It Means
Sponsors may need to invest in point-of-need ophthalmic services or coordinate patient travel for more specialized assessments. Without advance planning, logistical and scheduling challenges can compromise data quality and patient retention, especially if participants must travel significant distances.
7. 50% of sites or more are not affiliated with an academic institution or private ophthalmology practice: Yes / No
Why We Ask
Academic institutions and private ophthalmology practices often have in-house specialists and the necessary equipment for advanced assessments. Sites outside these networks might be less equipped to handle complex vision endpoints.
What It Means
If most sites aren’t affiliated with specialized eye-care infrastructure, you’ll likely need to provide robust central support, additional training, or third-party partners. Without these measures, data variability increases, and you risk protocol deviations.
Self-Assessment: Where Do You Fall on the Risk Spectrum?
Ask yourself the seven questions above and plot your answers on the spectrum below. The more “Yes” answers you record—and the more advanced the assessments are—the higher your overall risk will likely be.
Interpreting Your Score
- Mostly “No”: You likely have straightforward or minimal ophthalmic requirements. Your risk level is lower, but you should verify that each site has baseline competencies.
- Mixed: Some aspects are straightforward, while others demand advanced resources. You’ll need moderate planning around specialized sites, certifications, or equipment.
- Multiple “Yes”: Indicates a high risk of increased complexity. Expect the need for specialized partners, deeper site evaluations, and potentially larger budgets or longer timelines.
Conclusion
Clinical operations personnel must appreciate the nuances of what’s listed in their study protocols—especially regarding ophthalmic assessments. Seemingly minor details, like the difference between basic and advanced equipment requirements or how frequently you’ll dilate patients, can balloon into major operational and budgetary challenges.
Always evaluate your risk level. If you are at high risk, investing in specialized support, training, and infrastructure early on can pay off with fewer headaches, fewer deviations, and more robust data overall.
Next Steps
- Perform a risk assessment using the seven key questions above.
- Explore specialized ophthalmic partners if your trial tilts toward high-risk.
- Build in budget and timeline buffers for advanced imaging, equipment setup, and site training.
By planning for the unique complexities behind every “ophthalmic assessment,” you position your clinical trial for smoother execution and stronger, more reliable data.
20/20 Onsite can help ensure ophthalmic assessments align with the study's ocular endpoints. Our experts can help determine the best patient recruitment and study protocol to ensure compliance and successful trial completion. Contact us to book your free call.