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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Pre-Term

Intervention / Treatment
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* Diagnostic Test: Optos ultra-widefield retinal imaging (Optos California)


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Each premature infant recruited into the study will undergo retinal imaging with the Optos ultra-widefield retinal imaging device as well as the gold standard method of examination with the binocular indirect ophthalmoscope. The order of the procedures to be carried out in each infant will be determined by randomisation via sealed envelopes prepared remotely by a member of the pilot team not involved in the recruitment of patients or their screenings.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard then Intervention<br>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)<br>* retinal imaging device<br>|
| Experimental: Intervention then Standard<br>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)<br>* retinal imaging device<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opthalmology, neonatal, premature