About this trial
The purpose of this study is to test the repeatability and reproducibility in Rod Intercept (RI) time with two AdaptDx Pro devices in healthy subjects with normal vision.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or female between the ages of 22 and 49 (inclusive) at Visit 1
ETDRS BCVA letter score of 85 (Snellen equivalent of 20/20) or better at Visit 1
Able to communicate well with the Investigator and able to understand and comply with the requirements of the study
Informed of the nature of this study and has provided written informed consent in accordance with institutional, local and national regulatory guidelines
Disqualifiers
Unable to follow simple instructions, operate a response button or maintain attention for 20 minutes
Diagnosis or history of any ocular disease or disorder
Serious medical illness that will prevent the subject from performing study activities (including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic, or hematologic disease) or, in the judgement of the Investigator, is likely to require surgical intervention or hospitalization at any point during the study
Presence of or history of malignancy within the past year of Visit 1 other than non-melanoma skin or squamous cell cancer or cervical carcinoma in-situ
Trial population
Subjects who will be permitted into the study include those who meet all the inclusion criteria and have none of the exclusion criteria for both eyes at Visit 1 and confirmed at Visit 2.
Trial design
Cohort
Prospective
Treatments tested in this trial
AdaptDx Pro
Diagnostic testThe AdaptDx device measures changes in dark adaptation via rod intercept time.
Treatment groups
Trial outcomes
Primary outcomes
Rod Intercept Time (RIT)
Rod intercept time is the measure of time it takes for the human eye's rod photoreceptors to recover sensitivity and adjust from bright light to darkness
Sponsors and contacts
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