Status:
COMPLETED
Optos Versus Indirect Ophthalmoscopy for ROP Screening Examination (Optos vs BIO Study)
Lead Sponsor:
University Hospitals of Derby and Burton NHS Foundation Trust
Conditions:
Pre-Term
Eligibility:
All Genders
Phase:
NA
Brief 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...
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04292015
Start Date
August 14 2017
End Date
January 22 2018
Last Update
March 2 2020
Active Locations (1)
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1
University Hospitals of Derby & Burton NHS Foundation Trust
Derby, Derbyshire, United Kingdom, DE22 3DT