MedDataX Logo

Trial Outcomes & Findings for Wearable Dark-adaptometer in Normal Adult Healthy Volunteers (NCT NCT02674425)

NCT ID: NCT02674425

Last Updated: 2024-07-01

Results Overview

RCB (time) values were determined by recording the time required for the participant to observe a light stimulus of a particular luminosity. Participants viewed the light stimuli without their optical correction. These consisted of a white (λpeak = 464 nm; chromaticity coordinates - 2° observer: x = 0.269, y = 0.324) circular test target of 0.255 mm radius, forming a visual angle of around 33°. Participants were asked to press a response button on the handheld joystick when the test target was visible and had 750 ms to make a response after target onset. Target intensity started at approximately 4.865 cd\*m-2. Light stimuli were presented approximately every 2.6 s for a duration of 150 ms each. If the subject under test did not respond to the stimuli, the target intensity remained at the same initial level of approximately 4.865 cd\*m-2 until the subject responded. If the subject reported perception of the light stimulus within the response window, the luminance was reduced by 0

Recruitment status

COMPLETED

Target enrollment

20 participants

Primary outcome timeframe

40 minutes

Results posted on

2024-07-01

Participant Flow

Use of dietary intake of ascorbic acid, vitamin A, B, E or other antioxidant supplements in the last two weeks prior dark adaptometry was cause of exclusion from the study.

Participant milestones

Participant milestones
Measure
Young Adults (18-40)
Healthy adult volunteers, aged between 18 and 40, with no prior/current eye problems or family history of genetic eye diseases and good general health.
Older Adults (50-70)
Healthy adult volunteers, aged between 50 and 70, with no prior/current eye problems or family history of genetic eye diseases and good general health.
Overall Study
STARTED
10
10
Overall Study
COMPLETED
8
8
Overall Study
NOT COMPLETED
2
2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Wearable Dark-adaptometer in Normal Adult Healthy Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Young Adults (18-40)
n=10 Participants
Healthy adult volunteers, aged between 18 and 40, with no prior/current eye problems or family history of genetic eye diseases and good general health.
Older Adults (50-70)
n=10 Participants
Healthy adult volunteers, aged between 50 and 70, with no prior/current eye problems or family history of genetic eye diseases and good general health.
Total
n=20 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
10 Participants
n=5 Participants
7 Participants
n=7 Participants
17 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
3 Participants
n=7 Participants
3 Participants
n=5 Participants
Age, Continuous
29 years
n=5 Participants
58 years
n=7 Participants
45 years
n=5 Participants
Sex: Female, Male
Female
7 Participants
n=5 Participants
5 Participants
n=7 Participants
12 Participants
n=5 Participants
Sex: Female, Male
Male
3 Participants
n=5 Participants
5 Participants
n=7 Participants
8 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
10 Participants
n=5 Participants
10 Participants
n=7 Participants
20 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 40 minutes

RCB (time) values were determined by recording the time required for the participant to observe a light stimulus of a particular luminosity. Participants viewed the light stimuli without their optical correction. These consisted of a white (λpeak = 464 nm; chromaticity coordinates - 2° observer: x = 0.269, y = 0.324) circular test target of 0.255 mm radius, forming a visual angle of around 33°. Participants were asked to press a response button on the handheld joystick when the test target was visible and had 750 ms to make a response after target onset. Target intensity started at approximately 4.865 cd\*m-2. Light stimuli were presented approximately every 2.6 s for a duration of 150 ms each. If the subject under test did not respond to the stimuli, the target intensity remained at the same initial level of approximately 4.865 cd\*m-2 until the subject responded. If the subject reported perception of the light stimulus within the response window, the luminance was reduced by 0

Outcome measures

Outcome measures
Measure
Young Adults (18-40)
n=10 Participants
Healthy adult volunteers, aged between 18 and 40, with no prior/current eye problems or family history of genetic eye diseases and good general health.
Older Adults (50-70)
n=10 Participants
Healthy adult volunteers, aged between 50 and 70, with no prior/current eye problems or family history of genetic eye diseases and good general health.
Time to Rod-cone Break (RCB)
11.34 Minutes
Standard Deviation 1.37
9.98 Minutes
Standard Deviation 3.01

PRIMARY outcome

Timeframe: 40 minutes

Rod sensitivity (absolute threshold luminance) values measured in cd\*m-2

Outcome measures

Outcome measures
Measure
Young Adults (18-40)
n=10 Participants
Healthy adult volunteers, aged between 18 and 40, with no prior/current eye problems or family history of genetic eye diseases and good general health.
Older Adults (50-70)
n=10 Participants
Healthy adult volunteers, aged between 50 and 70, with no prior/current eye problems or family history of genetic eye diseases and good general health.
Absolute Threshold
4.56 cd/m^2
Standard Deviation 0.23
4.04 cd/m^2
Standard Deviation 0.65

PRIMARY outcome

Timeframe: 40 minutes

Time taken to reach absolution threshold measured in minutes

Outcome measures

Outcome measures
Measure
Young Adults (18-40)
n=10 Participants
Healthy adult volunteers, aged between 18 and 40, with no prior/current eye problems or family history of genetic eye diseases and good general health.
Older Adults (50-70)
n=10 Participants
Healthy adult volunteers, aged between 50 and 70, with no prior/current eye problems or family history of genetic eye diseases and good general health.
Absolute Threshold Time
28.99 Minutes
Standard Deviation 5.62
29.99 Minutes
Standard Deviation 7.01

Adverse Events

Older Adults (50-70)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Young Adults (18-40)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr

PolyPhotonix

Phone: 00441740625

Results disclosure agreements

  • Principal investigator is a sponsor employee The sponsor must agree with the company partner involved in this study prior to public release. The company partner involved in this study can require changes to the communication and can extend the embargo for a period that is more than 180 days from the time submitted to the sponsor for review.
  • Publication restrictions are in place

Restriction type: OTHER