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Completed

NCT Number: NCT04292015

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

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.

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Key information

Conditions

Pre-Term Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals of Derby & Burton NHS Foundation Trust

Derby, Derbyshire, DE22 3DT, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Optos ultra-widefield retinal imaging (Optos California)

Diagnostic Test

retinal imaging device

Primary outcomes

  1. Blood pressure (BP)

    Time frame: Baseline to 10 minutes following completion of both interventions

    Blood pressure (BP)

  2. Number of infants that develop bradycardia

    Time frame: Baseline to 10 minutes following completion of both interventions

    Defined as less than 100 beats per minute

  3. Oxygen saturation

    Time frame: Baseline to 10 minutes following completion of both interventions

    Number of infants who develop oxygen saturations below 85%

  4. Development of respiratory distress

    Time frame: Baseline to 10 minutes following completion of both interventions

    Number of infacnts who develop respiratory distress, defined as respiratory rate less than 30 breaths per minute

Secondary outcomes

  1. Determine and compare time taken to perform interventions

    Time frame: During intervention

    Time of each intervention recorded

Sponsors and collaborators

Lead sponsor

University Hospitals of Derby and Burton NHS Foundation Trust

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 2, 2020
Registry last updated
Mar 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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