Optos Versus Indirect Ophthalmoscopy for ROP Screening Examination (Optos vs BIO Study)

Impact of Retinopathy of Prematurity Screening Examination on Cardiorespiratory Indices - A Comparison of Optos Ultra-Widefield Retinal Imaging and Binocular Indirect Ophthalmoscopy

ROP is a preventable cause of blindness in premature infants. It is routinely screened for by using an indirect ophthalmoscope, a scleral depressor, and a condensing lens. This method of screening can cause significant cardiorespiratory distress to infants. A new camera (Optos California) has recently been used to image infants with different severities of ROP. The Optos California is capable of capturing up to 200 degrees of retina in a single image without contact with the eye. The non eye contact nature of the Optos California may cause less distress to infants who are due a ROP screening examination. The present study is to compare the impact of ROP screening examination between the Optos retinal camera and conventional binocular indirect ophthalmoscopy using cardiorespiratory indices (such as heart rate, oxygen saturations, blood pressure, and respiratory rate) as a measure of distress.

Study Overview

• Status: Completed
• Conditions: Pre-Term
• Intervention / Treatment: Diagnostic test: Optos ultra-widefield retinal imaging (Optos California)

Detailed Description

This is a pilot prospective randomised study. As part of the routine clinical care at RDH, all premature infants eligible for ROP screening as stated by the UK ROP screening guidelines will undergo the gold standard screening examination by a Consultant Ophthalmologist.

Each infant eligible for ROP screening will be routinely scheduled for several ROP screening examinations prior to discharge from the neonatal unit. For each infant who is eligible and whose parent(s) or legal guardian have agreed for them to be enrolled in the study, two additional procedures to the gold standard examination with the binocular indirect ophthalmoscope (as stated above) will be carried out at each of its routinely scheduled ROP screening examination.

The first additional procedure will be the acquisition of images of both fundi by Ophthalmology Specialty Registrar with the Optos ultra-widefield retinal-imaging device. Cardiorespiratory indices will be collected at different time points of the Optos retinal imaging procedure.

The second additional procedure will be the collection of cardiorespiratory indices (including the heart rate,respiratory rate, oxygen saturations, and blood pressure) by the paediatric research nurse at the time of the gold standard examination with the binocular indirect ophthalmoscope. The equipment used will be the same as those used to measure the cardiorespiratory indices during different time points of the Optos ultra-widefield retinal imaging procedure (see above).

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Derbyshire
    • Derby, Derbyshire, United Kingdom, DE22 3DT
      • University Hospitals of Derby & Burton NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Infants eligible for routine ROP screening using UK ROP screening guidelines (Any infant born at or before 32 weeks gestation and/or weigh 1500 grams or less).
• Infants with parents who have conversational English and who can give written informed consent.

Exclusion Criteria:

• Infants not eligible for routine ROP screening under UK ROP screening guidelines.
• Infants who are deemed not well enough by a consultant neonatologist (SO) for retinal examination or retinal imaging.
• Any premature infant with media opacities that prevents adequate visualisation of the retina.
• Inability of the parents to understand verbal and written English.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard then Intervention; Infant will undergo standard method of examination with binocular indirect opthalmoscope (BIO) followed by retinal imaging with Optos ultra-wide field retinal imaging device.	Diagnostic test: Optos ultra-widefield retinal imaging (Optos California); retinal imaging device
Experimental: Intervention then Standard; Infant will undergo retinal imaging with Optos ultra-wide field retinal imaging device followed by standard method of examination with binocular indirect opthalmoscope (BIO).	Diagnostic test: Optos ultra-widefield retinal imaging (Optos California); retinal imaging device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure (BP)	Blood pressure (BP)	Baseline to 10 minutes following completion of both interventions
Number of infants that develop bradycardia	Defined as less than 100 beats per minute	Baseline to 10 minutes following completion of both interventions
Oxygen saturation	Number of infants who develop oxygen saturations below 85%	Baseline to 10 minutes following completion of both interventions
Development of respiratory distress	Number of infacnts who develop respiratory distress, defined as respiratory rate less than 30 breaths per minute	Baseline to 10 minutes following completion of both interventions

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine and compare time taken to perform interventions	Time of each intervention recorded	During intervention

Collaborators and Investigators

• Sponsor: University Hospitals of Derby and Burton NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2017
• Primary Completion (Actual): January 22, 2018
• Study Completion (Actual): January 22, 2018

Study Registration Dates

• First Submitted: February 26, 2020
• First Submitted That Met QC Criteria: February 28, 2020
• First Posted (Actual): March 2, 2020

Study Record Updates

• Last Update Posted (Actual): March 2, 2020
• Last Update Submitted That Met QC Criteria: February 28, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: premature; neonatal; opthalmology
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: DHRD/2017/043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No