SBIR-STTR Award

During Phase I, the creation of a safe, valid, precise, reliable, research prototype instrument for testing the somatosensation of cornea, sclera, conjunctiva, and eyelid is expected. The specific aims of Phase I are to: (1) modify the existing Weinstein Oral Microaesthesiometer to create a new instrument, a corneal microaesthesiometer, for testing corneal somatosensation; (2) demonstrate validity and test-retest reliability; (3) develop norms on a small group of subjects; (4) explore the feasibility of obtaining cortical evoked potentials; and (5) explore, as available in the sample, the effects of age, sex, contact lenses, use of tobacco, and use of alcohol upon corneal thresholds.The long-term objective is to establish the corneal microaesthesiometer test as an office procedure for screening patients for: (1) systemic, ocular, or corneal problems; (2) for predicting recovery from surgery; and (3) for evaluating ideal ophthalmic dosing on an individual patient basis.The potential exists for the development of a corneal aesthesiometer that will not injure newly transplanted corneas, that will not elicit apprehension in patients, and that will give valid, precise, and reliable tests. Further, the new corneal aesthesiometer could be used to elicit cortical evoked potentials for the evaluation of infants or of mentally impaired patients. In addition, the following disadvantages of current corneal aesthesiometers will be avoided with this instrument: (1) risk of transmission of infection; (2) inability to deliver subthreshold stimulation; and (3) inducing apprehension in the patient from a visually approaching stimulus.National Eye Institute (NEI)

The specific aims are to develop norms for the only corneal aesthesiometer that tests nondestructively. Norms will consider both eyes of both sexes, for 8 decades of age (from less than 1O, through greater than or equal to 70) for three types of eyes (that are known to have differential sensitivity). Corneal sensitivity cannot now be evaluated accurately or precisely; further, current devices affect the cornea negatively during testing. This device is safely employed and precisely measures sensitivity. The device has application for ophthalmologists and optometrists.Awardee's statement of the potential commercial applications of the research:It has commercial application to those who: fit cosmetic or refraction-correcting contacting lenses, evaluate potential product induced corneal insensitivity (ocular irritation), and confirmed accident-induced corneal insensitivity. For example, for those who fit contact lenses, frank lack of corneal sensitivity is considered a contraindication for fitting; nevertheless, normal adaptation to the lenses results in a slight loss of corneal sensation. When the lenses wear out, however, they induce a much greater loss of corneal sensation that is clinically significant. The treatment is a new pair of lenses. Therefore, to insure proper, safe fit, eye-care professionals can now measure the loss of corneal sensation relative to the expected values for that person.National Eye Institute (NEI)