Pre-Term Clinical Trial
Official title:
Impact of Retinopathy of Prematurity Screening Examination on Cardiorespiratory Indices - A Comparison of Optos Ultra-Widefield Retinal Imaging and Binocular Indirect Ophthalmoscopy
ROP is a preventable cause of blindness in premature infants. It is routinely screened for by using an indirect ophthalmoscope, a scleral depressor, and a condensing lens. This method of screening can cause significant cardiorespiratory distress to infants. A new camera (Optos California) has recently been used to image infants with different severities of ROP. The Optos California is capable of capturing up to 200 degrees of retina in a single image without contact with the eye. The non eye contact nature of the Optos California may cause less distress to infants who are due a ROP screening examination. The present study is to compare the impact of ROP screening examination between the Optos retinal camera and conventional binocular indirect ophthalmoscopy using cardiorespiratory indices (such as heart rate, oxygen saturations, blood pressure, and respiratory rate) as a measure of distress.
This is a pilot prospective randomised study. As part of the routine clinical care at RDH,
all premature infants eligible for ROP screening as stated by the UK ROP screening guidelines
will undergo the gold standard screening examination by a Consultant Ophthalmologist.
Each infant eligible for ROP screening will be routinely scheduled for several ROP screening
examinations prior to discharge from the neonatal unit. For each infant who is eligible and
whose parent(s) or legal guardian have agreed for them to be enrolled in the study, two
additional procedures to the gold standard examination with the binocular indirect
ophthalmoscope (as stated above) will be carried out at each of its routinely scheduled ROP
screening examination.
The first additional procedure will be the acquisition of images of both fundi by
Ophthalmology Specialty Registrar with the Optos ultra-widefield retinal-imaging device.
Cardiorespiratory indices will be collected at different time points of the Optos retinal
imaging procedure.
The second additional procedure will be the collection of cardiorespiratory indices
(including the heart rate,respiratory rate, oxygen saturations, and blood pressure) by the
paediatric research nurse at the time of the gold standard examination with the binocular
indirect ophthalmoscope. The equipment used will be the same as those used to measure the
cardiorespiratory indices during different time points of the Optos ultra-widefield retinal
imaging procedure (see above).
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