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Trial Outcomes & Findings for Circadian Macular Volume Changes in the Choroid (NCT NCT02223546)

NCT ID: NCT02223546

Last Updated: 2020-09-24

Results Overview

macular choroidal volume in the central 6mm

Recruitment status

COMPLETED

Target enrollment

15 participants

Primary outcome timeframe

daily average out of measurements every 3 hours within a 24 hour timeframe

Results posted on

2020-09-24

Participant Flow

Participant milestones

Participant milestones
Measure
Healthy Subject
healthy subject, every 3 hour measurement
Overall Study
STARTED
15
Overall Study
COMPLETED
15
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Circadian Macular Volume Changes in the Choroid

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Healthy Subject
n=15 Participants
healthy subject, every 3 hour measurement
Age, Continuous
26 years
STANDARD_DEVIATION 1 • n=5 Participants
Sex: Female, Male
Female
7 Participants
n=5 Participants
Sex: Female, Male
Male
8 Participants
n=5 Participants

PRIMARY outcome

Timeframe: daily average out of measurements every 3 hours within a 24 hour timeframe

macular choroidal volume in the central 6mm

Outcome measures

Outcome measures
Measure
Healthy Subject
n=15 Participants
healthy subject, every 3 hour measurement
Macular Choroidal Volume
10.33 mm^3
Standard Deviation 2.53

SECONDARY outcome

Timeframe: daily average out of measurements every 3 hours within a 24 hour timeframe

Outcome measures

Outcome measures
Measure
Healthy Subject
n=15 Participants
healthy subject, every 3 hour measurement
Subfoveal Choroidal Thickness
378.1 µm
Standard Deviation 111.3

OTHER_PRE_SPECIFIED outcome

Timeframe: every 3 hours within a 24 hour timeframe

mean arterial pressure (MAP) is defined as DBP + 1/3(SBP - DBP); mean ocular perfusion pressure results from 2/3(MAP - IOP).

Outcome measures

Outcome data not reported

Adverse Events

Healthy Subject

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

Gerald Seidel, MD

Medical University of Graz

Phone: +43 316 385 12394

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place