Newborn Infant Vision Test

Period of Performance: 09/01/2017 - 08/31/2018

$469K

Phase 2 STTR

Recipient Firm

Precision Vision, Inc.
Woodstock, IL 60098
Principal Investigator

Abstract

Project Summary! This STTR Phase-II project continues the development of the Newborn Acuity Cardstm and the Newborn Contrast Cardstm. Together, these Newborn Cards form a new clinical test of visual acuity and contrast sensi- tivity for use on newborn full-term and preterm infants. The stimuli are square-wave gratings which the examiner presents to the infant in a fixation-and-following protocol, and determines from the infant's looking behavior whether he/she saw each stimulus or not. An infant's visual acuity or contrast sensitivity is the highest spatial frequency or lowest contrast (the least visible stimulus) he/she can see. The proposed Phase II work will include a training study in which the best method for training examiners in the use of the cards will be established and documented. The project will also establish age norms by meas- uring visual acuity and contrast sensitivity on a large sample of healthy full-term and preterm infants. Because the test is so new, it is not known how reliable the measurements are. Therefore, this project will include re- peated testing of individual newborn infants, on different days, by different examiners. The Intraclass Correla- tion Coefficient will determine whether measurement of an infant's level of visual function produces results that are more related to the infant's vision rather than to the more ephemeral characteristics of the infant's alertness or the skill of the examiner. The clinical utility of the test (its sensitivity and specificity in detecting vision disor- ders) has not been established, so this project will explore these parameters by testing a sample of infants with and without Retinopathy of Prematurity (ROP). ROP is not the only serious visual disorder experienced by newborn infants, but it is one of the most prevalent and most serious. This is not a clinical trial, but the results on infants with varying stages of ROP will be a good indicator of whether the Newborn Acuity Cards and Newborn Contrast Cards are sensitive and specific indicators of healthy visual function. The results on the ROP infants will also be used, in conjunction with the age norms, to establish a normal cutoff value for a screening test of only a few cards, which will further increase the convenience of this noninvasive test. The Newborn Contrast Cards and Newborn Acuity Cards will allow the physician to monitor the vision of patients in the Neonatal Intensive Care Unit and other pediatric settings, in cases where the visual disorder is progressing (as in Retinopathy of Prematurity or Cortical Vision Impairment) or where the disorder may be treated. Its potential market includes hospitals, neonatologists, pediatricians, and pediatric ophthalmologists around the world. In 71% of cases of childhood blindness in the U.S., the blinding disorder is present in the neonatal period, and the inability to see well may be the only sign of a blinding disorder in half of those cases. Ultimately, we want every newborn infant's vision to be screened, and every premature infant's vision to be tested more thoroughly, and this project will be the next step towards making this plan a reality.