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.
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
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.
- Conditions
- Retinopathy of Prematurity
- 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 group | Role | What they receive |
|---|---|---|
| Nurse led screening for ROP with OPTOS camera | Experimental | Screening 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.
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
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.
- First posted3 Oct 2023
- Study start10 May 2021
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals of Derby and Burton NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Shalini Ojha, Professor, Principal investigator, University of Nottingham
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Nurse-led Retinal Imaging for Retinopathy of Prematurity Screening Employing the Optos California
- ClinicalTrials.gov ID
- NCT06063863
- Acronym / sponsor ID
- N_ORS / 20046
- Conditions
- Retinopathy of Prematurity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- University Hospitals of Derby and Burton NHS Foundation Trust
- Study start
- 10 May 2021 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nurse led screening for ROP with OPTOS camera | Experimental | Diagnostic Test: Nurse led screening with Optos ultra-widefield retinal-imaging deviceScreening 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). |
Who may qualify
- Ages
- 32 weeks to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse led screening with Optos ultra-widefield retinal-imaging deviceThe 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 | Diagnostic test | Nurse led screening for ROP with OPTOS camera |
Primary outcome
Retinopathy of prematurity diagnosis
Time frame: 18 months
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.
Retinopathy of prematurity grading
Time frame: 18 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Background: PubMed 30322451Fung 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shalini Ojha, Professor principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
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.