Clinical Trials for the Enfant^® Pediatric VEP Vision Testing system were conducted at five leading eye care medical centers: Children’s Hospital of Philadelphia, Albany Medical Center, Wills Eye Hospital, Bronx Lebanon Hospital Center, and Columbia Presbyterian Medical Center.

The goal of the study was to determine the effectiveness of the Enfant^® in assessing visual impairments in infants and young children. In addition to the clinical effectiveness of the Enfant^®, the physicians involved in the trials established usability criteria that needed to be met if the VEP vision screening device was to be effective in a clinical environment. These included a testing time of less than ten minutes, a completion rate of at least eighty percent of all patients tested, and an ease of operation allowing an operator to competently use the device with less than three hours of training.

Of the one hundred and twenty-five patients participating in the trial, one hundred and nineteen patients successfully completed the VEP vision screening procedure, yielding better than a ninety-five percent completion rate. The test speed and completion rate exceeded physician expectations.

The following is a brief synopsis of the Clinical Study:

Introduction. With a prevalence of 3-5%, amblyopia represents a major public health problem. Effective treatment depends on early detection, and a broad consensus of professional opinion supports vision screening of infants and young children. No single method of screening has been demonstrated to be superior in detecting amblyopia and all methods have significant limitations.

Methods. A new, “child-friendly” Visual Evoked Potential (VEP) system (Enfant^® Diopsys, Inc., Pine Brook, NJ) for use in vision screening. 122 children, aged 6 months to 5 years, were tested, comparing test results in masked fashion to results of standard ophthalmologic examinations. A statistical program analyzed VEP differences between fellow eyes to determine a “pass” or “fail” for each child. For verbal patients, clinical amblyopia was defined as an interocular difference of two or more lines in best corrected visual acuity. For preverbal patients, clinical amblyopia was defined by the clinician’s decision to treat with occlusion or atropine penalization. Preverbal children with significant refractive errors or structural eye pathology were also considered clinical positives.

Results. The test was completed by 94% of the test sample, each child requiring an average of 10 minutes to complete testing of both eyes. The sensitivity was 0.973, specificity 0.808, positive predictive value 0.706, and the negative predictive value 0.984.