Optos Versus Indirect Ophthalmoscopy for ROP Screening Examination (Optos vs BIO Study) (NCT04292015) | Clinical Trial Compass
CompletedNot Applicable
Optos Versus Indirect Ophthalmoscopy for ROP Screening Examination (Optos vs BIO Study)
United Kingdom50 participantsStarted 2017-08-14
Plain-language summary
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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Blood pressure (BP)
Timeframe: Baseline to 10 minutes following completion of both interventions
2
Number of infants that develop bradycardia
Timeframe: Baseline to 10 minutes following completion of both interventions
3
Oxygen saturation
Timeframe: Baseline to 10 minutes following completion of both interventions
4
Development of respiratory distress
Timeframe: Baseline to 10 minutes following completion of both interventions
Trial details
NCT IDNCT04292015
SponsorUniversity Hospitals of Derby and Burton NHS Foundation Trust