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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04362215
Other study ID # 09/2019/1953
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 10, 2019
Est. completion date March 15, 2020

Study information

Verified date April 2020
Source Kecioren Education and Training Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Near vision deterioration during aging results from a decrease in accomodation amplitude (AA). Myocardial regeneration is limited, and cardiac aging is an independent risk factor for cardiovascular disease. Thus, the investigators investigated the association between cardiac aging and AA.

The subjects (500, mean 50-year-old subjects, with equal males and females) were divided into two groups according to AA measured with a Raf ruler. Biomicroscopy was used to capture images of the lens nucleus in the unaccommodated state, followed by images of a 4 diopter (D) accommodated state. The nucleus diameter change at 1 D accomodation was measured using ImageJ. Cardiac conduction system differences were evaluated using electrocardiography, and cardiac autonomic aging was assessed based on heart rate variability. Myocardial aging was assessed based on diastolic dysfunction.


Description:

Lens cells and proteins are encapsulated, and they are not turned over or replaced.The lens nucleus starts to form before birth, so the nucleus is one of the three oldest tissues in the body .With aging, continuous cardiomyocyte stress derails proteostasis by causing excessive autophagy and protease activation, and, ultimately, contractile and electrophysiological dysfunction. Aggregate deposition, proteostasis deterioration, and diffusion degradation between the nucleus and cortex are the main reasons for lens aging.Heart, lens, and neuronal cells change significantly with age, and they are older than cells from renewable tissues.

Near vision deterioration during aging results from a decrease in accomodation amplitude (AA). Cardiac aging is an independent risk factor for cardiovascular disease. Thus, the investigators investigated the association between cardiac aging and AA. The subjects (500 mean 50-year-old subjects, with equal males and females) were divided into two groups according to AA measured with a Raf ruler. The nucleus diameter change at 1 D accomodation was measured using ImageJ. Cardiac conduction system differences, autonomic aging, myocardial aging were evaluated using electrocardiography, heart rate variability and diastolic dysfunction. For near distance vision,compared to subjects who could see clearly from 24-28 cm, subjects who could see clearly from 29-33 cm had a 2.104-fold higher risk of a lateral e' velocity <10 cm/s[95%CI; 1.312-3.374], 2.603-fold higher risk of diastolic dysfunction[95%CI; 1.453-4.662], 1.54-fold higher risk of a low/high frequency ratio >3.1, [95%CI;1.085-2.197]. Subjective AA measurement can predict important heart aging parameters.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date March 15, 2020
Est. primary completion date March 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 49 Years to 51 Years
Eligibility Inclusion Criteria:

Healthy Volunteers, mean 50 years of age (49-51)

Exclusion Criteria:

Hypertension, Diabetes mellitus, Atrial fibrillation, Coronary artery disease, Arrhythmia, Hyperthyroidism , Anemia, Heart failure, Respiratory diseases, Severe obesity (body mass index =35 kg/m2),

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Subjective accomodation amplitude measurement
ECG:Electrocardiography Echocardiography, Holter implementation(for Lf/Hf ratio))

Locations

Country Name City State
Turkey ANkara Keçiören EAH Ankara

Sponsors (1)

Lead Sponsor Collaborator
Kecioren Education and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary ECG interval changes meauserements(ms,mm,number) ECG PR interval (ms),Ventricle Premature Systol(number),Left Ventricle Hypertrophy(mm)Right Bundle Branch,Left Bundle Branch (the presence / absence) 1 day
Primary Holter implementation To detect autonomic cardiac aging based on heart rate variability (HRV),the low frequency (LF)/high frequency (HF) ratio was measured using a CardioScan II (version 11.4.0054a; DMS Software, Stateline, NV, USA) 1 day
Primary Echocardiographic measurements Diastolic dysfunction meauserements(mitral anulus lateral e' velocity <10 cm/s, average E/e' ratio >14, Left atrium maximum volume index (LAv.i.) >34 mL/m2, and peak Tricuspit Regurgitation velocity >2.8 m/s. 1 day
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