Other and Unspecified Superficial Injuries of EyeNCT01317316
Causes and Characteristics of Occupational Eye Injuries in Western Turkey
An observational study of Other and Unspecified Superficial Injuries of Eye, run by Pamukkale University.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Other and Unspecified Superficial Injuries of Eye
- How many people
- 816 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older 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.
Who may be able to join
- The study sample comprised only the casualties occurred at workplace and while working de facto
Who cannot join
- Other
About this study
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.
Read the 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2011 (estimated)
- Study startJan 2007
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other and Unspecified Superficial Injuries of EyeStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 816 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Investigators
- mustafa serinken, MD, Study director, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317316
- Sponsor's protocol ID
- Serinken 003
- Status last verified
- Nov 2006
- First submitted
- 16 Mar 2011
- Last updated
- 17 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Causes and Characteristics of Occupational Eye Injuries in Western Turkey
- ClinicalTrials.gov ID
- NCT01317316
- Acronym / sponsor ID
- Serinken 003
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 816 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- Jan 2011 (actual)
- First posted
- 17 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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.
Key inclusion criteria (1 listed)
- The study sample comprised only the casualties occurred at workplace and while working de facto
Key exclusion criteria (1 listed)
- Other
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mustafa serinken, MD study director
Pamukkale University
Questions about this trial
What is this clinical trial studying?
An observational study of Other and Unspecified Superficial Injuries of Eye, run by Pamukkale University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2011.