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Risk of Radiation-induced Cataracts Among Interventional Cardiology Staff

Risk of Radiation-induced Cataracts Among Interventional Cardiology Staff- CATaracts Attributed to Radiation in the CaTh Lab: The IC-CATARACT Study

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02837562
Acronym
IC-CATARACT
Enrollment
0
Registered
2016-07-19
Start date
2016-05-31
Completion date
2018-12-01
Last updated
2019-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

Radiation exposure, Cardiac catheterization

Brief summary

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

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.

Interventions

OTHERSlit lamp eye examination

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

Sponsors

Dallas VA Research Corporation
CollaboratorINDUSTRY
University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Radiation associated lens opacitiesAt study completion, approximately 30 minutes after administration of mydriatic eye dropsMeasured by slit-lamp eye examination

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026