NCT04362215

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

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

September 10, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

6 months

First QC Date

April 20, 2020

Last Update Submit

April 23, 2020

Conditions

Aging

Keywords

agingheart agingpresbyopia

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

High AA group

Group 1 consisted of those having an AA level of 3.57-4.16 D (high AA group; those who had near clear vision between 24-28 cm). .

Diagnostic Test: Subjective accomodation amplitude measurement

Low AA group

Group 2 consisted of those having an AA level of 3.44-3.03 D (low AA group; those who had near clear vision between 29-33 cm)

Diagnostic Test: Subjective accomodation amplitude measurement

Interventions

Subjective accomodation amplitude measurementDIAGNOSTIC_TEST

ECG:Electrocardıography Echocardiography, Holter implementation(for Lf/Hf ratio))

Also known as: ECG,Echocardiography,Holter implementation
High AA groupLow AA group

Eligibility Criteria

Age49 Years - 51 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ANkara Keçiören EAH

Ankara, 06530, Turkey (Türkiye)

Location

Related Publications (1)

  • Koc S, Baysal SS. Heart aging when near vision difficulty begins. Aging Male. 2020 Dec;23(5):1346-1354. doi: 10.1080/13685538.2020.1766438. Epub 2020 May 25.

    PMID: 32449445DERIVED

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Şahbender Koç

    University of Health Sciences Ankara Keçiören Education Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 20, 2020

First Posted

April 24, 2020

Study Start

September 10, 2019

Primary Completion

March 15, 2020

Study Completion

March 15, 2020

Last Updated

April 24, 2020

Record last verified: 2020-04

Locations

TU(1)