Yes. Personal identifiable data will not be collected on the IGATES platform (such as name, social security number, date of birth etc.). The data entry personnel will be responsible for anonymizing the patient's identity by assigning a "Search Index ID" to the patient.
The data collected will include demographic details, circumstances and mechanism of injury, object causing injury, laterality, type of open globe injury, type of adnexal or orbital injury, clinical findings, investigations, treatment and surgical interventions, complications, and visual outcome. Clinical images will also be collected in some cases. Follow-up data will be collected for a period of 24 months following injury. For patients with bilateral eye injury, data will only be collected for the more severely injured eye, defined as the eye with the worse visual acuity at presentation. Clinical findings at presentation include details of the cornea, sclera, iris, lens, vitreous, retina, choroid and optic nerve. Details related to adnexal and orbital injuries will also be recorded. These include lid lacerations, lacrimal drainage apparatus involvement, extra ocular muscle involvement, orbital wall fracture, infraorbital paresthesia and Hertel’s measurement. Involvement of the central visual axis and time taken from injury to presentation is recorded. Follow-up variables includes BCVA, number and type of surgeries done and clinical examination findings. Investigations include ultrasound B-scan, electro-diagnostics, ultrasound biomicroscopy, X-ray of face/orbit, and CT or MRI face/orbit/brain. These investigations help confirm the presence or absence of intraocular foreign bodies, posterior segment pathology that could not be visualized on slit- lamp biomicroscopy and other orbital and non-ophthalmic injuries.
The main dependent variable representing visual outcome is the final best corrected visual acuity (BCVA) which is taken at the latest follow up the patient attended, in the absence of any new injury or unrelated ocular/ophthalmic condition.
The classification for type of open globe or closed globe injury is in accordance with the Birmingham Eye Trauma Terminology System (BETTS).
Open globe injuries involving full thickness wound of the eye are classified into rupture or laceration (penetrating, perforating or intraocular foreign body).
Closed globe injuries not involving full thickness wound of the eye are classified into contusion or lamellar laceration.
Analysis of data will be performed after the period of data collection. Our statisticians will employ sophisticated statistical tools and machine learning tools to create the OTS-2. Initial statistical analysis will involve descriptive statistics (frequencies, mean, median, mode, standard deviation), univariate and multivariate analysis and survival analysis with the dependent variable being the final best corrected visual acuity (BCVA).
You may begin to upload data onto the IGATES platform before the ethics approval has been given and before the agreement has been made.
During the period before the ethics approval and agreement are done, IGATES users will not be allowed to access or extract the data that you have uploaded.
The uploading of clinical photographs, diagrams or documents are not mandatory but supplementary.
There is no fixed protocol for how patients should be followed up.
The details of patients with all kinds of ocular trauma (e.g., open globe, closed globe chemical injury etc.) can be uploaded onto IGATES.
Prospective. You should categorize a patient in the prospective group as long as the patient has presented to you in the current or previous month.
It is understandable that sometimes one may not be able to comprehensively fill up all data points in an emergency setting.
No, there is no maximum number of users.
You will have to create a new account and notify the IGATES administrators at “firstname.lastname@example.org” that you had made an error. This is so the administrator can help to disable the account where the wrong details had been entered. There is currently no way for IGATES administrators to delete accounts. This is for accountability purposes as IGATES requires a comprehensive list of all accounts created if there is ever a case of a data leak.
This differs between patients categorized as retrospective or prospective. For the retrospective group, consent is usually not required to be taken. For the prospective group, it depends on your local ethics board if consent is required. We will be releasing an IGATES consent form that you may use to take consent from patients categorized in the prospective group.
Yes. Members are required to undergo a training session before they are able to upload data onto the patient registry. This is to ensure the quality of data entered. A certificate of completion will be awarded to members who have undergone the training session.