FAQs

1. WILL ALL DATA BE DE-IDENTIFIED ON IGATES?

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.

2. WHAT TYPE OF DATA WILL BE COLLECTED?

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.

3. HOW ARE GLOBE INJURIES CLASSIFIED IN OUR STUDY?

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.

4. HOW WILL THE STATISTICAL ANALYSIS BE DONE?

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).

5. WHEN MAY I START UPLOADING DATA ONTO IGATES? DO I HAVE TO WAIT FOR ETHICS APPROVAL BEFORE I CAN BEGIN UPLOADING DATA?

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.

IS THE UPLOADING OF IMAGES MANDATORY?

The uploading of clinical photographs, diagrams or documents are not mandatory but supplementary.

7. FOR PATIENTS THAT FALL UNDER THE PROSPECTIVE GROUP, ARE THERE ANY PROTOCOLS THAT ONE SHOULD FOLLOW IN TERMS OF WHEN TO FOLLOW-UP?

There is no fixed protocol for how patients should be followed up.

8. WHAT TYPES OF EYE INJURIES MAY I UPLOAD ONTO IGATES?

The details of patients with all kinds of ocular trauma (e.g., open globe, closed globe chemical injury etc.) can be uploaded onto IGATES.

9. IF A PATIENT WHO COMES IN WITH ENDOPHTHALMITIS AND A HISTORY OF OCULAR TRAUMA ONE OR TWO MONTHS AGO, SHOULD WE CATEGORIZE THIS PATIENT AS A RETROSPECTIVE OR PROSPECTIVE CASE?

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.

10. MANY OCULAR TRAUMA PATIENTS PRESENT IN EMERGENCY SITUATIONS. AS SUCH, SOME PATIENTS MAY NOT GET WORKED UP THOROUGHLY AND AS A RESULT THERE MAY BE SOME DATA POINTS LEFT EMPTY. WILL THIS BE AN ISSUE FOR DATA QUALITY?

It is understandable that sometimes one may not be able to comprehensively fill up all data points in an emergency setting.

may select the “Not assessed” option first if the situation is time urgent. Later on, when the patient is more stable and you are able to assess them, you have the option of going back to edit the record and fill in missing data points. Even if certain data points are missing in records, we can analyse the records with incomplete data separately. Therefore, it is still very useful to upload the records of these patients.
11. IS THERE A MAXIMUM NUMBER OF USERS THAT SITE ADMINISTRATORS CAN REGISTER ON IGATES?

No, there is no maximum number of users.

12. WHAT SHOULD I DO IF I HAD ENTERED WRONG DETAILS WHEN REGISTERING A NEW USER? (APPLIES TO SITE ADMINISTRATORS ONLY)

You will have to create a new account and notify the IGATES administrators at “support@oculartrauma.com” 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.

13. DO I NEED TO TAKE PATIENT CONSENT BEFORE UPLOADING THEIR RECORDS ONTO IGATES?

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.

14. IS ATTENDING THE IGATES TRAINING SESSION MANDATORY?

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.