Feasibility of Nurse-led Retinal Imaging for Retinopathy of Prematurity Screening Employing the Optos California - Trial NCT06063863
Access comprehensive clinical trial information for NCT06063863 through Pure Global AI's free database. This phase not specified trial is sponsored by University of Nottingham and is currently Completed. The study focuses on Retinopathy of Prematurity. Target enrollment is 52 participants.
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Study Focus
Nurse led screening with Optos ultra-widefield retinal-imaging device
Interventional
diagnostic test
Sponsor & Location
University of Nottingham
Timeline & Enrollment
N/A
May 10, 2021
Aug 01, 2023
Primary Outcome
Retinopathy of prematurity diagnosis,Retinopathy of prematurity grading
Summary
Retinopathy of prematurity (ROP) is a preventable cause of blindness in babies who are born
 early i.e. premature. Internationally, there is a shortage of skilled ophthalmologists
 willing and able to screen for ROP. Even in the UK, not all hospitals have skilled
 ophthalmologists and premature babies have to travel to other hospitals, often long
 distances, to have their eyes examined. As a missed examination can lead to sight loss, this
 is a burden for families and carers of premature babies. To fill this gap, previous studies
 have explored the use of non-ophthalmologists healthcare workers to increase the workforce
 screening for ROP.
 
 Recently, the Optos ultra-widefield retinal-imaging device (Optos PLC, Dunfermline, Scotland,
 UK) has been used to help document different stages of ROP in infants. This specialised
 retinal imaging system uses an internal ellipsoid mirror to capture fundal imaging angles of
 up to 200 degrees, or more than 80% of the entire retina, in a single image. A single retinal
 image can be acquired in a quarter of a second and is automatically captured when the
 infant's pupils are aligned with the Optos imaging device. No contact with the eye is
 necessary to capture an image of the retina. To date, there are no studies that have
 validated the Optos as a nurse-led screening tool for ROP.
 
 This is a prospective study to determine and validate the feasibility of neonatal nurse-led
 retinal imagers for ROP screening employing the Optos imaging device. The main purpose of
 this study will be to test if it is possible for trained nurses to take good images of the
 back of babies eyes (retina) and if these images can be used by remotely placed
 ophthalmologists to diagnose and grade ROP. The investigators will compare how good the
 diagnosis and grading done using Optos images are compared to the current gold standard
 method (BIO). The investigators will also test how much agreement there is between
 ophthalmologists in interpreting Optos images by asking two ophthalmologists to grade the
 images.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06063863
Non-Device Trial