CONN HASTINGS EXCLUSIVE, OPHTHALMOLOGY

Innovega Inc., a systems engineering and lens development company with offices in Washington and California, has created eMacula, a new generation of eyewear that combines smart contact lenses and stylish, lightweight glasses. The system will be tailored to the needs of vision impaired patients who will benefit from both lens-based vision correction and from magnification and digital enhancement of the view of their surroundings.

The eMacula solution responds directly to the fact that the vision of these patients cannot be sufficiently improved by techniques based on the use of normal glasses lenses or contact lenses. By capturing an image of the wearer’s surrounding, magnifying it greatly, then providing it as a panoramic near-eye display, Innovega aims to improve the wearer’s sensory performance. This has the potential to restore some percentage of the lifestyle these people have lost. As an extension to this patient aid, the same system of smart contact lenses and display glasses could be used to deliver digital media directly to the wearer (virtual reality), or to allow the wearer to simultaneously view their surroundings and media that is useful (augmented reality (AR)). The eMacula system is therefore flexible and configurable based on the user’s preferences.

In the case of an AR configuration, the eMacula system is different from previous AR glasses, such as Google Glass, which delivered-a low resolution, single-eye, narrow (15-degree) field of view experience. The eMacula system delivers mega-pixel resolution across a panoramic (50–100 degrees) field of view experience, and to each of the wearer’s eyes.

The personalized contact lens component of the eMacula system incorporates the wearer’s usual vision prescription, but also a small lens at its center which enables the user to focus on digital content provided by near-eye microdisplays mounted within the glasses.

Innovega is currently engaged in seeking FDA approval for the new generation of contact lenses that are used in the system, and both wearer testing and Phase II clinical trials are under way. Innovega has also designed an intra-ocular lens that could be surgically implanted during cataract surgery inside the eye, which can provide the user with an improved view of their surrounding, plus an ability to view near-eye, high performance displays mounted in smart glasses. A complete appraisal of this opportunity will require clinical assessment in the future.

See a video about the eMacula system below:

Medgadget had the opportunity to ask Steve Willey, Innovega CEO, some questions about the technology and ongoing trials of the technology.

Conn Hastings, Medgadget: Why haven’t previous AR glasses, such as Google Glass, been successful? What makes eMacula different?

Steve Willey: AR glasses have failed to meet even the most basic needs of the human wearer which include: normal, stylish appearance; lightweight and comfortable; useful and compelling AR display performance that includes panoramic overlay, high-resolution media, unobstructed view of one’s surroundings; and in-focus simultaneous view of both real-world and digital media. No less important is the fact that more than 60% of wearers will also need a means of vision correction and will not wear AR glasses if they experience symptoms of eye-strain. This list of expectations and needs holds true for all wearers, irrespective of whether they are consumers, workers, or patients.

Medgadget: Please give us an overview of the components of the system and how they work together.

Steve Willey: Our eyewear system comprises two key elements: 1. Glasses with integrated display screens; 2. Contact lenses that enable the wearer to view their surroundings with clarity while also viewing “near-eye” digital information or media that is delivered from high-resolution microdisplays fixed within the glasses. This new generation of “smart” contact lens incorporates the wearer’s vision prescription (if required) to ensure a clear, real-world view as well as a lens that delivers in-focus clarity of over-laid media. The lens is “smart” since it separately processes the wearer’s real-world view from display media – and does so without the need for any form of electronics. These Innovega optics are passive in nature and will meet expectations that wearers will have for a comfortable, disposable contact lens.

Medgadget: How could the eMacula system assist those with vision impairment? Can the system provide digital zoom or image enhancement to help users to more easily perform daily activities?

Steve Willey: eMacula glasses incorporate a high-resolution camera that captures the wearer’s surroundings and in particular, items of interests that given the visual handicap of target patients would not otherwise be discernible. Digital zoom or magnification is applied to the captured scene, as well as scene enhancement techniques that the wearer will adjust based upon their needs. The process of capture, magnification, processing and near-instant display of the image to eyewear screens is not unique. Delivering this magnified image over a wide field of view and from lightweight glasses is entirely unique. Unless the image is displayed over a wide field of view, the context of the greatly magnified image is lost. For example, a sentence when magnified ten or more times might appear in the eyewear display as a single word – unless the display and optics delivered an extremely large field of view that allowed the expanded field of view required by the magnified image. By providing this aid in the form of a contact lens and appearing as normal, comfortable glasses, we expect patients to become much more mobile and begin returning to the lifestyle that so many lose when faced with a vision impaired condition.

Medgadget: What types of digital content are conceived as being used on the system? How will the product fit into peoples’ lives?

Steve Willey: As examples of life-style changes, patients wearing eMacula lenses and glasses would be able to more easily view and interpret small print on the packaging of food items, read smart phone screens, recognize the faces of persons they interact with, and generally complete myriad other tasks that those not suffering from vision impairment take for granted. The digital content of interest to the patient would be an enhanced view of their surrounding world and its impact on improving their independence and lifestyle. However, since we envision – and are designing – the eyewear’s ability to access smart phone applications and processing capability, there will be every opportunity to enhance the aid well beyond scene magnification and expansion and add benefits of accessing other digital media. For example, a face of an approaching person could be captured by the camera and analyzed, quickly recognized and the wearer notified by visual or audio communication.

It is this quality of digital performance plus conventional glasses form-factor that combine to support and enhance in a natural way the normal routines that those with vision impairment need and want to recover.

Medgadget: Please give us an overview of the ongoing clinical trials and the FDA approval process.

Steve Willey: The iOptik contact lens is in clinical development. Four rounds of clinical studies were completed at the Ohio State University with fully sighted subjects plus one round with visually impaired subjects. These were feasibility studies to support development of the optics of the lens. We are now conducting studies with the fully optimized optics and filters with fully sighted and visually impaired subjects. Some of these are funded by the National Eye Institute of the National Institutes of Health. We conducted our face to face meeting with the FDA and learned of their preferences for our FDA clinical investigation for the iOptik lens. We also have a lens material that is already FDA approved for implanted medical devices. We are seeking a 510(k) clearance for use of this material as a daily wear contact lens for standard indications of vision correction. This clearance supports the FDA process with the iOptik lens which has the addition of light polarizing filters and the center small lens for viewing the near eye display.

Medgadget: What are your future plans for the intra-ocular lens that Innovega has designed?

Steve Willey: The iOptik contact lens is a first step for the visually impaired. Even so, age related macular degeneration (AMD) is a leading cause of visual impairment. Cataracts are also age related. The iOptik intra-ocular lens (IOL) is a logical next step to assist eye care practitioners in helping patients who have AMD and need cataract surgery. The iOptik IOL will allow post-surgical ability to use near eye displays with a wide field of view that allows for image enhancement needed for useful vision. The FDA approval of the iOptik contact lens followed by its commercialization will provide the market acceptance information to support the use of the iOptik intra-ocular lens. We will conduct human trials of the iOptik IOL after the FDA process is underway with the iOptik contact lens.