Iris DiseasesNCT05759715
Iris Color and Day-Night Changes in the Sympathovagal Ratio
An observational study of Iris Diseases, run by Ankara Ataturk Sanatorium Training and Research Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Iris Diseases
- What is being tested?
- Iris Color Measurement , LF/HF Measurement
- How many people
- 621 participants
- Where
- No sites listed yet
- Study dates
- 5 May 2016to Jun 2022
- 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 16 to 50 years
- All sexes
- Child, Adult
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.
Who may be able to join
- A total of 650 healthy individuals between the ages of 16 and 50 .
Who cannot join
- Diseases that could affect the autonomic nervous system; Obesity Obstructive sleep apnea syndrome Hypertension Diabetes mellitus Atrial fibrillation Coronary disease Heart failure Goiter, etc.
About this study
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.
Read the detailed description
A total of 621 healthy adults, aged between 16 and 50, with brown eyes and not diagnosed with a disease that might affect the autonomous nerve system were included in the study. A digital camera was used to acquire iris photos. Subjects were grouped into iris color groups (2-0 bg, 1-0 bg, 1-1 db, 1-1 lb, 2-0 b, and 1-0 b). Iris photos were analyzed with Picture Color Analyzer RBG software. The Central/Peripheral (R/RGB) ratio was used for objective distinction between the groups. Using 24-h Holter ECG monitoring, the change in the sympathovagal ratio from day (between 07:00 and 23:00 hrs) to night (between 23:00 and 07:00 hrs) was determined with the formula [(Day - Night) LF/HF)/Day LF/HF].
- Conditions
- Iris Diseases
- Being tested
- Iris Color Measurement , LF/HF Measurement
- Keywords
- LF/HF ratio, iris color, melanin
- Medical subject headings
- Iris Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iris Color Measurement , LF/HF MeasurementOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 2-0 darkbown-green (2-0 bg) | Those with distinctively dark brown in the central area, slightly green in the peripheral area, Receives: 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, Receives: 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. Receives: 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. Receives: 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 . Receives: 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 . Receives: Other: Iris Color Measurement , LF/HF Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start5 May 2016
- Primary completion5 May 2022
- Study completionJun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iris DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 621 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Şahbender Koç, Ankara Ataturk Sanatorium Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759715
- Sponsor's protocol ID
- 1099/9.3.2016
- Status last verified
- Mar 2023
- First submitted
- 27 Feb 2023
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iris Color and Day-Night Changes in the Sympathovagal Ratio
- ClinicalTrials.gov ID
- NCT05759715
- Acronym / sponsor ID
- 1099/9.3.2016
- Conditions
- Iris Diseases
- Keywords
- LF/HF ratio, iris color, melanin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 621 participants (actual)
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research HospitalOther government
- Study start
- 5 May 2016 (actual)
- Primary completion
- 5 May 2022 (actual)
- Study completion
- Jun 2022 (actual)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A total of 621 healthy adults, aged between 16 and 50, with brown eyes and not diagnosed with a disease that might affect the autonomous nerve system were included in the study. A digital camera was used to acquire iris photos. Subjects were grouped into iris color groups (2-0 bg, 1-0 bg, 1-1 db, 1-1 lb, 2-0 b, and 1-0 b). Iris photos were analyzed with Picture Color Analyzer RBG software. The Central/Peripheral (R/RGB) ratio was used for objective distinction between the groups. Using 24-h Holter ECG monitoring, the change in the sympathovagal ratio from day (between 07:00 and 23:00 hrs) to night (between 23:00 and 07:00 hrs) was determined with the formula [(Day - Night) LF/HF)/Day LF/HF].
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 2-0 darkbown-green (2-0 bg) | – | Other: Iris Color Measurement , LF/HF MeasurementThose with distinctively dark brown in the central area, slightly green in the peripheral area, |
| 1-0 lightbrown-green (1-0 bg). | – | Other: Iris Color Measurement , LF/HF MeasurementThose with slightly dark brown in the central area and green in the peripheral area, |
| dark brown (1-1 db) | – | Other: Iris Color Measurement , LF/HF MeasurementEyes with the same color structure in the central iris and the peripheral iris. |
| light brown (1-1 lb) | – | Other: Iris Color Measurement , LF/HF MeasurementEyes with the same color structure in the central iris and the peripheral iris. |
| dark brown (2-0 b) | – | Other: Iris Color Measurement , LF/HF MeasurementThose with distinctively dark brown in the central iris area compared to the periphery . |
| slightly dark brown (1-0 b) | – | Other: Iris Color Measurement , LF/HF MeasurementThose with slightly dark brown (1-0 b) in the central iris area compared to the periphery . |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- A total of 650 healthy individuals between the ages of 16 and 50 .
Key exclusion criteria (1 listed)
- Diseases that could affect the autonomic nervous system; Obesity Obstructive sleep apnea syndrome Hypertension Diabetes mellitus Atrial fibrillation Coronary disease Heart failure Goiter, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iris Color Measurement , LF/HF MeasurementIris Color Measurement (Photos were taken of the iris with a digital camera ) LF/ HF Measurement (Using the three-channel standard ambulatory Holter recording system) | Other | 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) |
Primary outcome
LF/HF ratio
Time frame: one week
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Iris Diseases, run by Ankara Ataturk Sanatorium Training and Research Hospital.
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 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
LF/HF ratio (time frame: one week). 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 9 Mar 2023.