Page 105 - Advanced concepts in orbital wall fractures
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                                Materials and methods
Study design
A two-centre, multidisciplinary, prospective, observational cohort study
was designed to monitor outcome of an updated clinical research protocol.
The protocol divided patients in two study groups – one receiving surgical
treatment and the other nonsurgical treatment. This study was conducted
in accordance with the World Medical Association Declaration of Helsinki
on medical research ethics. The approval of this study was waived by the institutional medical ethical authority (file number W13_303 # 13.17.373)
and informed consent was acquired for all patients who participated in
the study. All data were anonymised and de-identified prior to analysis. Consecutive patients with an orbital floor and/or medial wall fracture
attending the Amsterdam UMC (location AMC) or the Amphia Hospital
Breda between April 1, 2014 and April 1, 2017 were included. Inclusion
criteria were patients aged 18 years or older with an isolated orbital floor
and/or medial fracture that was no older than 7 days. Exclusion criteria
were the presence of other orbital fractures, globe perforation, relevant pre-existing pathology of the eye (e.g. amblyopia, squint, or diplopia) or
the inability to undergo the diagnostic examination. C
Study protocol 6 First presentation
Clinical examination was performed (subjective diplopia, enophthalmos,
infraorbital hypesthesia, hypoglobus, pain, and other symptoms) and
a computed tomography (CT) scan (orbital series, 1 mm slices) was obtained. Ophthalmic and orthoptic examinations (exophthalmometry, vision, bulb pressure, ductions, and field of binocular single vision (BSV)) were performed and recorded as early as possible. If there were any restrictions (e.g. obstructions due to swelling or lacerations) in performing these tests they were noted. Based on the measurements and the severity of the fracture the patient was included in either the surgical or nonsurgical group. A trapdoor fracture, persisting oculocardiac reflex, or vertical globe displacement into the maxillary sinus required immediate surgery within 24 hours. Early enophthalmos (>2 mm) or a fracture with Jaquiéry classification II/III/IV in combination with a limitation in elevation
Clinical perspective
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