Pre-Term Clinical Trial
Official title:
Impact of Retinopathy of Prematurity Screening Examination on Cardiorespiratory Indices - A Comparison of Optos Ultra-Widefield Retinal Imaging and Binocular Indirect Ophthalmoscopy
Verified date | February 2020 |
Source | University Hospitals of Derby and Burton NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | January 22, 2018 |
Est. primary completion date | January 22, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University Hospitals of Derby & Burton NHS Foundation Trust | Derby | Derbyshire |
Lead Sponsor | Collaborator |
---|---|
University Hospitals of Derby and Burton NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood pressure (BP) | Blood pressure (BP) | Baseline to 10 minutes following completion of both interventions | |
Primary | Number of infants that develop bradycardia | Defined as less than 100 beats per minute | Baseline to 10 minutes following completion of both interventions | |
Primary | Oxygen saturation | Number of infants who develop oxygen saturations below 85% | Baseline to 10 minutes following completion of both interventions | |
Primary | 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 | Determine and compare time taken to perform interventions | Time of each intervention recorded | During intervention |
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