Atrial Fibrillation Duration and Cortical Lens Opacity

October 24, 2024 updated by: Şahbender Koç, Ankara Ataturk Sanatorium Training and Research Hospital

Predicting the Presence and Duration of Atrial Fibrillation From Cortical Lens Opacity

The prevalence of atrial fibrillation (AF) and the risk of stroke increase with a higher CHA2DS2-VASc score. Osmotic stress, which also contributes to cortical cataract formation, increases in the presence of diseases that raise the CHA2DS2-VASc score. Knowledge of AF duration is crucial because it heightens the risk of AF-related complications. This study investigated whether the presence of cortical cataracts, classified using the Lens Opacity Classification System (LOCS)stage, can predict the presence and duration of AF.

Study Overview

Status

Completed

Detailed Description

Atrial fibrillation (AF) is the most common type of heart rhythm disorder encountered in clinical settings and is associated with increased morbidity and mortality. The prevalence of AF and the risk of stroke increase with higher CHA2DS2-VASc scores . Cortical cataracts develop at the periphery of the lens and progress toward the center in a spoke-like pattern. The incidences of AF and cortical cataracts significantly increase with age .

Similar to subclinical AF, the initial onset of AF may go undetected, and the time required for AF to become permanent varies. Longer episodes of AF and higher CHA2DS2-VASc scores are strongly associated with an increased annual risk of stroke or systemic embolism , making it essential to estimate the duration of AF.

Cortical cataract stages can be easily identified and monitored through simple biomicroscopic examination. To our knowledge, no reliable method currently exists to predict the duration of AF of unknown onset. This study investigated the relationship between cortical cataract stages and the presence and duration of AF by analyzing p.osmolarity data and comparing it with the LAVI.

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ankara, Turkey, 06530
        • Ankara Atatürk Sanatoryum TR Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study included 400 patients: 200 patients without AF (100 female, 100 male) and 200 patients with AF (100 female, 100 male). The patients' median age was 70 years. Patients with New York Heart Association class 1, 2, or 3 heart failure (HF) were included, regardless of the cause of HF.

Description

Inclusion Criteria:

Atrial Fibrillation patients

Exclusion Criteria:

Advanced HF (New York Heart Association class 4), Decompensated HF Prior cataract surgery Diabetic ketoacidosis Alcohol use Severe hyponatremia [sodium level of < 125 mEq/L], Nephrotic syndrome Cirrhosis Hypothyroidism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
group 1 ,group 2
The patients' median age was 70 years. Patients with New York Heart Association class 1, 2, or 3 heart failure (HF) were included, regardless of the cause of HF. Both groups comprised patients with a similar number and duration of comorbidities that contributed to their CHA2DS2-VASc scores.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cortical cataract opacification grading.
Time Frame: day1
All participants underwent detailed eye examinations using a biomicroscope . Digital photographs of the lenses were then captured using a smartphone under retro-illumination. Due to its simplicity, the Lens Opacity Classification System 2 [LOCS 2-Cortical] was used to perform cortical cataract opacification grading.
day1
LAVI (left atrial volume index)(ml/m2)
Time Frame: day1
LAVI were measured using a GE Vivid N60 echocardiography system
day1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

March 1, 2024

Study Completion (Actual)

June 1, 2024

Study Registration Dates

First Submitted

September 24, 2024

First Submitted That Met QC Criteria

October 24, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

October 28, 2024

Last Update Submitted That Met QC Criteria

October 24, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Relationship between cortical cataract stages and the presence and duration of AF

IPD Sharing Time Frame

1-2 mounts

IPD Sharing Access Criteria

All data generated in this study are available upon request from the corresponding authors except patient lens photographs.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrial Fibrillation (AF)

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