A Study to Test the Repeatability and Reproducibility in Rod Intercept Time Within the AdaptDx Pro in Healthy Subjects With Normal Vision (FlashForward)

ConditionNo Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22-49
SponsorAdaptDx, Inc.

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • AdaptDx Pro

    Diagnostic test

    The AdaptDx device measures changes in dark adaptation via rod intercept time.

Treatment groups

16 Participants
are divided into 1 treatment group
Group A: AdaptDx Pro Wearable1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Immediately after test

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.