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Autonomic Nervous System DiseasesNCT03322904

Sympathetic-parasympathetic Ratio of Our Gaze

An observational study of Autonomic Nervous System Diseases, run by Kecioren Education and Training Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Autonomic Nervous System Diseases
What is being tested?
iris photography
How many people
400 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Mar 2016to 5 Mar 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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

Who may be able to join

  • We enrolled apparently healthy subjects

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Şahbender Koç

    Ankara, 06400

Other trials in Turkey (Türkiye)

About this study

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.

Read the detailed description

INTRODUCTION The iris is the only tissue in which simultaneous interactions among smooth muscles stimulated by sympathetic and parasympathetic nerves can be observed with the naked eye. The iris contains the neural crest, which is comprised of the autonomous nervous system (ANS) and dorsal root ganglia . Fibers from the hypothalamus join the parasympathetic system through the dorsal longitudinal fasciculus and the medial forebrain bundle and unite with the Edinger-Westphal nucleus or the lateral horns of the thoracic spinal cord. A portion of these parasympathetic fibers innervate the constrictor muscle fibers of a circular structure underneath the area up to the collarette and limit the iris pupil via the oculomotor nerve. The hypothalamus is the major control and integration center of the ANS. The sympathetic nerves emerging from the hypothalamus extend along the length of the carotid artery synapse with the superior cervical ganglion and subsequently innervate the mydriasis muscle fibers beneath the iris collarette and iris root.

Heart rate variability (HRV) refers to changes in the time interval between heartbeats and is regulated by the ANS. Sympathetic and parasympathetic activities can be determined at a certain sensitivity by HRV assessment using low frequency (LF) and high frequency (HF) measurements. Previous epidemiological studies have shown that HRV is associated with both cardiac and non-cardiac all-cause mortality.

.The ANS is activated when we open our eyes, and the amount of light is adjusted by the iris . Non-visual impacts of light are mediated by melanopsin-based photoreceptors in the retinal photosensitive ganglia cells . Melanopsin is also found in the melanophores of the iris and inner brain. Phtosensitive retinal ganglion cells transmit light stimuli to the suprachiasmatic nucleus (SCN; circadian center) via the retinohypothalamic tract. In the dark, melatonin released rhythmically from the pineal gland also strongly affects SCN neuronal activity. This area receives stimulation from the visual photoreceptor system and from various areas of the brain, including the brain stem, limbic system, and cerebral cortex and contains multiple synapses with the pineal gland. The input of light into the retina, which is adjusted by the iris, is associated with the areas of the brain that regulate the ANS. Light may cause acute physiological effects such as rapid melatonin suppression, increased alertness, and increased heart rate and sympathetic nerve tonus.

The anterior cingulate cortex, amygdala, parabrachial nucleus, hypothalamus, periaqueductal grey matter, anterior insula, and some areas of the medulla play significant roles in the regulation of cardiac function. These cerebral structures are associated with cardiac activity via the sympathetic and parasympathetic nervous systems.

The objective of the study was to determine the degree of reflection of the estimated iris muscle area (IRIS) ratio of iris muscles innervated by parasympathetic and sympathetic nerves and its relationship with HRV, which is an ANS indicator of the heart.

MATERIALS AND METHODS A total of 400 healthy volunteers (200 males and 200 females) with brown eyes were included in the study. The investigators enrolled apparently healthy subjects who had no history of diabetes mellitus, hypertension, coronary artery disease, heart failure, cigarette smoking, eye disease, psychological illness, or drug therapy affecting the ANS.

A three-channel standard ambulatory Holter recording system (DMS Software Cardioscan II Holter monitoring system, ver. 11.4.0054a) was used to measure the pulse rate by HRV frequency domain analysis after removing the artefacts. The LF (0.04-0.15 Hz) and HF (0.16-0.4 Hz) ratings were recorded for 24 hours (day and night average).

Photographs of both irises of the healthy volunteers were taken using a digital camera (5-megapixel camera, 1.75 μm pixels, 0.5× digital zoom, LED flash) in the same room in daylight, at the same time of day with the same flash. Patients with non-specific and interrupted collarette (peripupillar ring) limits were not included in the study. 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. IEC-PC refers to the estimated total area of the dilator plus constrictor muscles stimulated sympathetically and parasympathetically; CC-PC refers to the estimated area stimulated parasympathetically; and [IEC-PC¬]-[CC-PC] refers to the estimated area stimulated sympathetically. The likelihood that the IRIS ratio was equal to the LF/HF ratio was calculated using the formula [IEC-PC¬] - [CC-PC] / [CC-PC]. The average of three measurements was calculated for each photograph.

The statistical analyses were carried out using SPSS for Windows 22 (IBM SPSS Inc., Chicago, IL, USA). The normality of the data distribution was assessed using the Kolmogorov-Smirnov test. Numerical variables with a normal distribution are presented as means ± standard deviation, while those with a nonnormal distribution are presented as medians (range). The t-test (for numerical variables displaying a normal distribution) and Mann-Whitney U-test (for numerical variables displaying an abnormal distribution) were used to determine differences between two independent groups. The association between the numerical parameters was determined by Pearson and Spearman correlation analyses. The Bland-Altman analysis was used to assess differences in compliance of the IRIS ratio and the LF/HF ratio in terms of ICC. A p-value < 0.05 was considered significant.

Studies were carried out in compliance with the Declaration of Helsinki after obtaining approval from the ethics committee. Informed consent was obtained from all subjects prior to participation.

The investigators identified a relationship between the IRIS ratio and HRV in 400 healthy subjects and demonstrated cardiac autonomic function. The IRIS ratio can also be applied to diseases accompanied by cardiac autonomic dysfunction. However, further studies are needed to demonstrate a relationship between the IRIS ratio and HRV in patients with cardiac disease.

Being tested
iris photography
Keywords
iris collarette; autonomous nervous system
Medical subject headings
Autonomic Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iris photographyDiagnostic test

    Also called holter implementation

    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].

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 11months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2017
  2. Study start10 Mar 2016
  3. Primary completion5 Mar 2017
  4. Study completion5 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03322904
Sponsor's protocol ID
09.03.2016/1100
Status last verified
Oct 2017
First submitted
10 Oct 2017
Last updated
26 Oct 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Autonomic Nervous System Diseases, run by Kecioren Education and Training Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation between iris ratio and LF/HF ratio (time frame: 11months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.

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