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Retinopathy of PrematurityN_ORSNCT06063863

Feasibility of Nurse-led Retinal Imaging for Retinopathy of Prematurity Screening Employing the Optos California

A study testing Nurse led screening with Optos ultra-widefield retinal-imaging device in people with Retinopathy of Prematurity, run by University of Nottingham at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 32 weeks to 1 year
Conditions the study is for
Retinopathy of Prematurity
What is being tested?
Nurse led screening with Optos ultra-widefield retinal-imaging device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteUnited Kingdom
Study dates
10 May 2021to 1 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 32 weeks to 1 year
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Infants (upper age limit 1 years old) eligible for routine ROP screening as part UK ROP screening guidelines (any infant born at or before 32 weeks' gestation and / or weigh 1500 grams or less).
  • Infants with parents/legal guardians who can give written informed consent.

Who cannot join

  • Infants not eligible for routine ROP screening under UK ROP screening guidelines.
  • Infants who are deemed not well enough by the attending consultant neonatologist for retinal examination or retinal imaging.
  • Any premature infant with media opacities that prevents adequate visualisation of the retina.
  • Inability of the parents to give written, informed consent.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • University Hospitals of Derby and Burton

    Derby, Derbyshire, DE22 3DT

Other trials in United Kingdom

About this study

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.

Read the detailed 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.

Being tested
Nurse led screening with Optos ultra-widefield retinal-imaging device
Medical subject headings
Retinopathy of Prematurity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nurse led screening with Optos ultra-widefield retinal-imaging deviceDiagnostic test

    The screening will be completed by nurse trained in using an OPTOS camera, at the same time as screening for ROP by a trained ophthalmologist using standard procedure for screening for ROP using binocular indirect ophthalmoscopy (BIO). Images taken with OPTOS will then be remotely assessed by a qualified independent opthalmologist, to see if they can diagnose and grade ROP accurately using these images

Study groups in NCT06063863
Study groupRoleWhat they receive
Nurse led screening for ROP with OPTOS cameraExperimentalScreening completed by nurse trained in the use of an OPTOS camera to obtain images, at the same time as screening via standard procedure by a trained ophthalmologist using binocular indirect ophthalmoscopy (BIO).
Receives: Diagnostic Test: Nurse led screening with Optos ultra-widefield retinal-imaging device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Retinopathy of prematurity diagnosis

    To evaluate the agreement by measuring the Kappa Co-efficient for agreement, for diagnosis and grading of ROP and posterior pole (pre-plus or plus disease) and peripheral retinal vascular changes, between nurse-led OPTOS imaging and indirect Ophthalmoscopy performed by an ophthalmologist.

    Measured: 18 months

  2. Retinopathy of prematurity grading

    To evaluate the agreement by measuring the Kappa Co-efficient for agreement, for diagnosis and grading of ROP and posterior pole (pre-plus or plus disease) and peripheral retinal vascular changes, between nurse-led OPTOS imaging and indirect Ophthalmoscopy performed

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2023
  2. Study start10 May 2021
  3. Primary completion1 Aug 2023
  4. Study completion1 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06063863
Sponsor's protocol ID
20046
Acronym
N_ORS
Status last verified
Sep 2023
First submitted
20 Jul 2023
Last updated
3 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fung THM, Abramson J, Ojha S, Holden R. Systemic Effects of Optos versus Indirect Ophthalmoscopy for Retinopathy of Prematurity Screening. Ophthalmology. 2018 Nov;125(11):1829-1832. doi: 10.1016/j.ophtha.2018.06.001. Epub 2018 Jul 6. No abstract available.

    PubMed 30322451

Questions about this trial

What is this clinical trial studying?

A study testing Nurse led screening with Optos ultra-widefield retinal-imaging device in people with Retinopathy of Prematurity, run by University of Nottingham at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retinopathy of prematurity diagnosis (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06063863, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.

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