Neuro-Eye Diagnostic Systems, LLC
Group 4a and 4b was an FDA trial that showed that patients who have an Amsler grid abnormality on paper, have a similar abnormality on the app. Group 7a and 7b was an FDA trial that showed that normal patients do not have false positives on the Amsler app as well as on the Amsler paper version. Further Vision on the app is slightly better than vision on the standard Sloan near card using a formula (vision is 7/10th of a line better on the app).
Detailed Description of 4A and 4B: A series of patients with central visual defects were identified and their names were given to the unblinded clinical coordinator. The clinical coordinator contacted the patients, described the study, arranged the appointments to come to the clinic one-at-a-time for a dedicated visit to participate in the study. Each patient experienced the same study process for their visit: 1. Met with the unblinded Clinical Coordinator who had the patient sign the informed consent after detailed explanation. 2. Had the Clinical Coordinator put a number tag on the patient,…
Inclusion Criteria for 4a and 4b: The participant must have at least one eye which complies with all the inclusion criteria Inclusion criteria: 1. Patients have had a standard ICNVT in the last six months which could potentially qualify a patient's eye for study participation. This information will be used to determine whether to proceed with screening the patient with the remaining study selection criteria below. 2. In the proposed study eye, the patient has at least one scotoma or field-cut, metamorphopsia or doubling area that is non-overlapping and that has boundaries separated by more…
Smartphone app that allows vision testing
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