NCT05759715

Brief Summary

Iris melanocytes are innervated by parasympathetic and sympathetic nerve endings. Light affects autonomic nervous system activity via the retino-hypothalamic pathway. The hypothesis that the day-to-night variations in the sympatovagal ratio (LF/HF) may differ among individuals with different brown iris patterns was tested.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
621

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Longer than P75 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2016

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2022

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
Last Updated

March 9, 2023

Status Verified

March 1, 2023

Enrollment Period

6 years

First QC Date

February 27, 2023

Last Update Submit

March 7, 2023

Conditions

Keywords

LF/HF ratio, iris color, melanin

Outcome Measures

Primary Outcomes (1)

  • LF/HF ratio

    low frequency (LF, 0.04-0.15 Hz) and high frequency (HF, 0.16-0.4 Hz) measurements were taken from day and night changes in the heart rate by using the frequency-domain analysis method.

    one week

Study Arms (6)

2-0 darkbown-green (2-0 bg)

Those with distinctively dark brown in the central area, slightly green in the peripheral area,

Other: Iris Color Measurement , LF/HF Measurement

1-0 lightbrown-green (1-0 bg).

Those with slightly dark brown in the central area and green in the peripheral area,

Other: Iris Color Measurement , LF/HF Measurement

dark brown (1-1 db)

Eyes with the same color structure in the central iris and the peripheral iris.

Other: Iris Color Measurement , LF/HF Measurement

light brown (1-1 lb)

Eyes with the same color structure in the central iris and the peripheral iris.

Other: Iris Color Measurement , LF/HF Measurement

dark brown (2-0 b)

Those with distinctively dark brown in the central iris area compared to the periphery .

Other: Iris Color Measurement , LF/HF Measurement

slightly dark brown (1-0 b)

Those with slightly dark brown (1-0 b) in the central iris area compared to the periphery .

Other: Iris Color Measurement , LF/HF Measurement

Interventions

Iris Color Measurement (Photos were taken of the iris with a digital camera ) LF/ HF Measurement (Using the three-channel standard ambulatory Holter recording system)

1-0 lightbrown-green (1-0 bg).2-0 darkbown-green (2-0 bg)dark brown (1-1 db)dark brown (2-0 b)light brown (1-1 lb)slightly dark brown (1-0 b)

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

A total of 650 healthy individuals between the ages of 16 and 50 who applied for cardiac examination and had normal findings were recruited for the study.

You may qualify if:

  • A total of 650 healthy individuals between the ages of 16 and 50 .

You may not qualify if:

  • Diseases that could affect the autonomic nervous system; Obesity Obstructive sleep apnea syndrome Hypertension Diabetes mellitus Atrial fibrillation Coronary disease Heart failure Goiter, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Iris Diseases

Condition Hierarchy (Ancestors)

Uveal DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD Cardıologist

Study Record Dates

First Submitted

February 27, 2023

First Posted

March 8, 2023

Study Start

May 5, 2016

Primary Completion

May 5, 2022

Study Completion

June 1, 2022

Last Updated

March 9, 2023

Record last verified: 2023-03