A retrospective cross-sectional study was carried out between January 1, 2015 and December 31, 2017 with the participation of the University Hospital of Santander (HUS by its acronym in Spanish), which facilitated the collection of information.
Eligibility Criteria
Children under 15 years old with trauma to the eyeball or its adnexa were included. The clinical reports that had little clinical correlation of data or erroneous diagnoses within the area were excluded.
Setting and sample
Through a non-probabilistic sampling for convenience. The eye injuries presenting over three years to the Ophthalmology Services of the University Hospital of Santander, who met the selection criteria were included.
Clinical evaluation
Initially, patients were evaluated in the emergency room of the HUS, and in case of alterations that affected the eyes, they were referred to the Ophthalmology Unit where they were evaluated by optometrists and ophthalmologists.
Demographic information, date of injury (cause, mechanism, type, clinical signs) and visual outcome were recorded for medical charts of all patients. The ocular examination was carried out with direct ophthalmoscope, slit lamp and to explore the fundus was used the indirect ophthalmoscope in case of clear ocular media with +20 Diopter lens. Visual acuity was mesured using the Landolt C chart and Snellen’s charts. For preschool children, the visual acuity was evaluated with the fixation.
The information available in the medical record was reorganized according to Birmingham Eye Trauma Terminology, two more categories were included (Eye burns and Ocular adnexa injuries).
Statistical analysis
A univariate descriptive analysis was carried out applying the relevant statistical tests according to the nature and scale of measurement of the variables. Measures of central tendency and dispersión were considered in the case of quantitative variables, while for qualitative variables, the calculation of proportions was considered.
The normality of the continuous data was tested, and the median was used with the interquartile range (IQR) when a non-normal distribution was presented.
Additionally, bivariate analysis was performed to establish the association between sociodemographic variables (age, sex, education, affiliation to the health system, place of residence) and clinical characteristics such as the type of trauma and its corresponding mechanisms using the Fisher’s Exact Test.
The analysis was done in the software Stata 14.
Ethical considerations
This paper follows the foundations outlined in the Declaration of Helsinki.
The Ethics Committees in scientific research of the Universidad Industrial de Santander (Colombia) waive the requirement for inform consent to develop the study because the investigation achieves with the following points:
- The study involves minimal to no risk to subjects because the only known risk to patients is the possible loss of confidentiality, which has been guarded against by limited access personnel to the database and password protection as well.
- The waiver will not adversely affect the rights and welfare of the subjects because this study is non-interventional and does not affect the subject’s rights for patient care and does not interfere with the welfare. Subject confidentiality will be protected by the assignment of a code for the identification in the study.
- The research could not practicably be carried out without the waiver because much time as elapsed since these subjects were last seen locally and the pediatric ocular trauma is a rare event, for that reason the study had to be carried out retrospectively.
- This study is non-interventional and thus providing information to patients is not likely. Also, they are reviewing medical récords but are not recording identifiers. They would not be able to link subjects back to the study and therefore would not be able to provide additional information.
Information from the medical records was extracted by two senior Optometry students using a collection format designed for the study.