Causes and Characteristics of Occupational Eye Injuries i... | NCT01317316

Studies
Causes and Characteristics of Occupational Eye Injuries in Western Turkey

NCT01317316

Sponsor

Pamukkale University

Status

Completed

Last Update Posted

Mar 17, 2011Estimated

Enrollment

816Actual

Phase

Not provided

Conditions

Other and Unspecified Superficial Injuries of Eye

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Not provided

Completion Date

Jan 2011Actual

First Submitted Date

Mar 16, 2011

First Submission Date that Met QC Criteria

Mar 16, 2011

First Posted Date

Mar 17, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2011

Last Update Posted Date

Mar 17, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Patients with work-related eye injuries (WREI) admitted to the center in the four-year period were enrolled in this prospective study. Institutional Review Board approval was obtained before commencement of the study. A special data recording system was developed for the study. The study sample comprised only the casualties occurred at workplace and while working de facto. The data were abstracted via face to face contact in the emergency department (ED). The data sheets comprised sociodemographic and injury-related information brought together in 15-item questionnaire. Causes of occupational injuries as reported by the victims were assigned to either of two groups: "Worker-related causes" and "workplace-related causes".

Since workers are known to be pressured by the workplace to work in unsafe ways, an isolated room in the ED was used for this purpose in order to prevent bias and the patients were not accompanied by any person other than the medical personnel in charge of due medical care. The patients were also assured that the information obtained by the survey are to be used for research purposes only and no feedback is to be given to employers or related persons.

Patients who did not give consent for the study, fatal accidents and patients younger than 15 years of age were excluded from the analysis.

Detailed Description

All data obtained in the study were recorded in and analyzed using the Statistical Package for Social Sciences for Windows, Version 17. Numerical variables were given as mean and standard deviation (SD), while categorical variables were given as frequencies (n) and percentages.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

816Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The study sample comprised only the casualties occurred at workplace and while working de facto

Exclusion Criteria:

Other

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with WREI admitted to the center in the four-year period were enrolled in this prospective study. Institutional Review Board approval was obtained before commencement of the study. A special data recording system was developed for the study. The study sample comprised only the casualties occurred at workplace and while working de facto.

Sampling Method

Non-Probability Sample