Risk of Radiation-induced Cataracts Among Interventional Cardiology Staff

NCT ID: NCT02837562

Last Updated: 2019-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of the present study is to evaluate the prevalence of radiation-associated lens opacities among interventional cardiology staff members (such as physicians, technicians, and nurses) and determine its association with occupational history.

The hypothesis of the study is that interventional cardiology staff will have high prevalence of radiation-induced lens opacities, which will be higher than non-interventional cardiology staff and will correlate with the estimated cumulative lifetime dose.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is an observational, cross-sectional study to evaluate the prevalence of posterior subcapsular cataract (PSC) and its association with prior occupational history of radiation exposure. Participants of the Society of Cardiovascular Angiography and Interventions 2016 Scientific Sessions to be held in Orlando, FL May 4th to May 7th, will be invited to participate. Both interventional cardiology and non-interventional cardiology staff and non-clinical participants will be assessed. Written informed consent will be obtained from all participants. They will subsequently be asked to complete a questionnaire on occupational radiation exposure, workplace practices and medical history followed by dilated slit lamp examination using a modified Merriam-Focht scoring system.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cataract

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Interventional Cardiology/Cath Lab Staff

This is considered to be the "case" or group under study. These are Interventional Cardiology/ Cardiac Cath lab staff that are exposed to radiation as a result of their role as Cardiac Cath lab staff.

Intervention: Slit lamp eye examination

Slit lamp eye examination

Intervention Type OTHER

All participants in the trial will undergo a slit lamp eye examination

Non-Interventional Cardiology/ Controls

This is considered to be the "control" or comparison group. These are non-interventional cardiology/ non-cardiac cath lab staff that are not exposed to radiation as they do no operate/ work in the Cardiac Cath Lab.

Intervention: Slit lamp eye examination

Slit lamp eye examination

Intervention Type OTHER

All participants in the trial will undergo a slit lamp eye examination

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Slit lamp eye examination

All participants in the trial will undergo a slit lamp eye examination

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Willing to undergo eye examination
* Participant at Society of Cardiovascular Angiography and Interventions 2016 Scientific Sessions

Exclusion Criteria

* Known pre-existing severe eye disease, such as glaucoma
* Prior lens surgery
* Known hypersensitivity to the mydriatic agents
* Any other conditions that may preclude participation/ performance of slit lamp eye examination/ use of mydriatics, in the opinion of the investigator
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dallas VA Research Corporation

INDUSTRY

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Emmanouil S Brilakis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STU-042016-016

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Endothelial Cell Loss After Cataract Surgery
NCT00932191 TERMINATED PHASE2/PHASE3