The Ophthalmology Program in the FDA’s Center for Devices and Radiological Health (CDRH) conducts regulatory science research to help ensure patients have access to innovative ophthalmology devices that are safe and effective. This is one of 20 research programs in CDRH’s Office of Science and Engineering Laboratories (OSEL).
Ophthalmology and Medical Devices
Vision is arguably our most important sense. Like most medical device fields, ophthalmic devices are either diagnostic (for example, retinal imager) or therapeutic (for example, retinal prosthesis, lasers, stents, intraocular lenses). Optical imaging is particularly important for ophthalmology because of accessibility to the eye’s transparent layers, which can benefit patients with ocular diseases but also those with neurological diseases that have retinal manifestations. Therapeutic ophthalmic devices are intended to maintain vision, restore vision, or relieve a condition (for example, stents to relieve high pressure in glaucoma).
The wide variety of clinical applications and types of ophthalmic medical devices can lead to inconsistency in safety and efficacy evaluation caused in part by inexistent, insufficient, or inefficient testing methods or protocols. These inconsistencies result in increased testing costs and delays in the regulatory process.
Regulatory Science Gaps and Challenges
Major regulatory science gaps and challenges that drive the Ophthalmology Program are:
- Lack of standard methods to evaluate systems performance and aid clinical translation of personalized Adaptive Optics (AO) devices.
- Lack of validated, cellular-level, functional clinical endpoints for ophthalmic diseases to detect a therapeutic response in a short timeframe (less than 1-2 years) to prove efficacy for novel treatments.
- Lack of test methods, clinical performance goals, and recognized standards for evaluation of Optical Coherence Tomography (OCT) device effectiveness.
- Insufficient information and experimental data to evaluate safe levels of stimulation for retinal prostheses submissions;
- Lack of standard test methods and protocols for evaluation of critical optical and scattering characteristics of NTIOL implants.
- Unclear safety and efficacy profiles and lack of performance evaluation of new materials and methods for new Corneal Cross-Linking (CXL) treatment paradigms.
The Ophthalmology Program is designed to fill these knowledge gaps by fostering the investigation and understanding of safety, effectiveness, and performance parameters for the successful translation of promising ophthalmic diagnostics and therapeutic devices to patients.
Ophthalmology Program Activities
The Ophthalmology Program focuses on regulatory science research in the following areas:
- Structural and functional AO-based biomarkers of retinal diseases
- Phantom-based model eyes as a standardized performance profile
- OCT test methods and defining clinical performance goals
- Optical methods to assess safe subretinal/suprachoridal prosthetic electrical stimulation devices and human-based models
- Safety and efficacy of novel nanoshell prosthetic devices
- Multifunctional standardized tools to evaluate critical optical and scattering characteristics that affect safety and performance of NTIOL implants
- New CXL methods and materials, especially silk protein-based biodegradable material platforms for corneal tissue engineering and regenerative medicine.
For more information, email OSEL_ophthalmology@fda.hhs.gov