Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06063863 |
| Other study ID # |
20046 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 10, 2021 |
| Est. completion date |
August 1, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
University of Nottingham |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Retinopathy of Prematurity (ROP) is the major cause of blindness in babies who are born early
i.e. premature (defined as those born at less than 37 weeks' gestation). All premature
infants are at risk of developing ROP and are therefore routinely screened for the condition.
With improvements, it has become one of the few preventable causes of childhood blindness,
and recent reports suggest that most babies are saved from sight loss with proper screening
and treatment. As neonatal care gets better, more premature babies are surviving and the need
for ROP screening is increasing all over the world: about 8200 babies need screening in the
UK each year. Very few babies need treatment - less than 2% in the UK. At the Royal Derby
Hospital (RDH), about 4 to 5 infants are screened each week, with only 1 to 2 needing
treatment per year.
The international classification of ROP describes ROP by its severity or stage (Stages 1-5),
location by zone (I-III), extent by clock hours, and by the presence of pre-plus and plus
disease. The aim of screening is to find out if the baby has any of these so that treatment
can be done if needed. All babies born before 32 weeks or at less than 1500 g birth weight
must have regular screening. For those born at <27 weeks gestation, the first ROP screening
examination should be undertaken when at 30 to 31 weeks corrected gestational age while for
babies who are more mature at birth, it is done between 4 to 5 weeks of actual age. Follow-up
examinations should be performed every 1 to 2 weeks thereafter until the ophthalmologists
(eye doctors) can see that the retina is fully matured. If there are signs of ROP,
examinations should be performed more frequently, either weekly or twice a week.
All ROP screening examinations are currently done by a highly trained ophthalmologist using
binocular indirect ophthalmoscopy (BIO), which is considered the gold standard method. The
retinal findings are seen and drawn by hand in the patient's notes. These screening
examinations are time-consuming for the ophthalmologist, and costly for the medical system as
they need the ophthalmologist to be physically present and to do the screening. This makes it
difficult for babies in remote hospitals or settings without trained ophthalmologists to have
ROP screening. To reduce this difficulty several groups have developed cameras that can take
pictures of the retina. The pictures can then be transferred to ophthalmologists who can
diagnose and grade the ROP remotely.
The most common imaging system used for ROP screening is the RetCam (Clarity Medical Systems,
Pleasanton, California, USA). The RetCam imaging system, a hand-held camera, is connected by
a fiber optic cable to an electro-optical box housed in a movable cart. To take images with
RetCam, the babies pupils have to be dilated (opened up) by using medicines and local
painkillers. The eyelids are held open with a lid speculum and the camera probe is applied
with a contact lens gel such that it is touching the front of the eye, over the open pupil.
RetCam images are not able to include the whole of the back of the eye in one picture and
therefore multiple images have to be taken. This takes time and effort from highly-skilled
imagers. Also, the picture quality is not good if the pupil is not opened properly or if
there is some obstruction in the way such as blood in the eye. As the camera has to touch the
eye, it can hurt the eye and make the baby uncomfortable such as by stimulating eye nerves
that cause the heart to slow down and lower the baby's blood oxygen levels. Too much pressure
on the eye can also change the picture and make the diagnosis difficult.
More recently, a new camera, the Optos ultra-widefield retinal-imaging device (Optos PLC,
Dunfermline, Scotland, UK) has been used to take and store pictures of different stages of
ROP in babies. This camera has a specialised mirror to capture pictures that contain details
of nearly all of the retina in a single photo. It is quick, the complete single photo can the
taken in a quarter of a second. In addition, it can take pictures without touching the baby's
eyes so there is no risk of damage to the eye. Thus, the Optos camera has many advantages
over the RetCam.
If this camera could be used by nurses trained to take pictures and ophthalmologists could
diagnose and grade ROP from these pictures, babies could be screened without every hospital
needing to have a specially trained ophthalmologist or the baby travelling distances to go to
a centre that had such a doctor. As most babies only need screening, ophthalmologists could
ask for only those who need treatment (about 2 in 100 babies) to be transferred to specialist
centres. This could reduce the cost of care to the NHS and problems for families of premature
babies.
In the Derby neonatal unit, the study team have already tested the Optos camera and found
that it is safe to use in babies and did not cause them any undue discomfort. In this study,
the study team want to see if it is possible to train a nurse to take pictures of the retina
using the Optos camera and if ophthalmologists can diagnose and grade ROP accurately using
these images. No studies have been done to test this.
