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

NCT06063863 | Completed

• 1 other identifier: 20046
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Retinopathy of Prematurity

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  18 months

Study Arms (1)

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).

Diagnostic Test: Nurse led screening with Optos ultra-widefield retinal-imaging device

Interventions

Nurse led screening with Optos ultra-widefield retinal-imaging device DIAGNOSTIC_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

Nurse led screening for ROP with OPTOS camera

Eligibility Criteria

• Age: 32 Weeks - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nottingham: lead
• University Hospitals of Derby and Burton NHS Foundation Trust: collaborator

Study Sites (1)

University Hospitals of Derby and Burton

Derby, Derbyshire, DE22 3DT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 30322451 BACKGROUND

MeSH Terms

Conditions

Retinopathy of Prematurity

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Shalini Ojha, Professor

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: October 3, 2023
• Study Start: May 10, 2021
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)