NCT03322904

Brief Summary

ABSTRACT BACKGROUND The existence of the retinohypothalamic pathway suggests that light may influence autonomic outflow activity. The objective of this study was to examine the correlation between the estimated iris muscle sympathetic-parasympathetic area (IRIS) ratio and the sympathetic-parasympathetic ratio (low frequency \[LF\]/high frequency \[HF\] ratio). METHODS The study population consisted of 200 females and 200 males (mean age, 32.4 ± 7.1 years). The IRIS ratio was determined from digital photographs of the iris in a computer setting. The LF/HF ratio was determined from records of heart rate variability obtained using a Holter implementation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 26, 2017

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

12 months

First QC Date

October 10, 2017

Last Update Submit

October 23, 2017

Conditions

Keywords

iris collarette; autonomous nervous system

Outcome Measures

Primary Outcomes (1)

  • Correlation between iris ratio and LF/HF ratio

    we have conducted with 400 healthly subjects iris muscle ratio associated with heart rate variability and it is demonstrated cardiac autonomic function. Iris muscle ratio can also be used in diseases accompanied by cardiac autonomic dysfunction.Correlation between pupil diameter and heart rate variability have also been investigated in some diseases where autonomic nervous system disorders are coincident. In Parkinson's disease (PD) is accompanied by autonomic nervous system dysfunction with neurodegenerative changes.. Jain et al. demonstrate simultaneous autonomic nervous system dysfunction in both pupillary diameter and in cardiac system via heart rate variability in PD Similarly, it has been shown that pupil functions in schizophrenia, which have previously been shown to be accompanied by cardiac autonomic dysfunction, may be proportional to the severity of the schizophrenia

    11months

Interventions

iris photographyDIAGNOSTIC_TEST

The LF (0.04-0.15 Hz) and HF (0.16-0.4 Hz) ratings were recorded for 24 hours (day and night average) by Holter recording system Photographs of both irises of the healthy volunteers were taken . An image software program was used to draw circular limits over the iris exterior circle (IEC), coloretta circle (CC), and pupil circle (PC) on digital photographs. The areas between the circles were measured. The likelihood that the IRIS ratio was equal to the LF/HF ratio was calculated using the formula \[IEC-PC¬\] - \[CC-PC\] / \[CC-PC\].

Also known as: holter implementation

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A total of 400 healthy volunteers (200 males and 200 females) with brown eyes were included in the study.

You may qualify if:

  • We enrolled apparently healthy subjects

You may not qualify if:

  • History of diabetes mellitus, hypertension, coronary artery disease, heart failure, cigarette smoking, eye disease, psychological illness, or drug therapy affecting the ANS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Şahbender Koç

Ankara, 06400, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Autonomic Nervous System Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

  • Zuhal Koç, specialist

    Saglik Bilimleri Universitesi

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardıologıst

Study Record Dates

First Submitted

October 10, 2017

First Posted

October 26, 2017

Study Start

March 10, 2016

Primary Completion

March 5, 2017

Study Completion

March 5, 2017

Last Updated

October 26, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations