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

NCT ID: NCT04292015

Last Updated: 2020-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-14
• Study Completion Date: 2018-01-22

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 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

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).

Conditions

Pre-Term

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Standard then Intervention

Infant will undergo standard method of examination with binocular indirect opthalmoscope (BIO) followed by retinal imaging with Optos ultra-wide field retinal imaging device.

Group Type: EXPERIMENTAL

Optos ultra-widefield retinal imaging (Optos California)

Intervention Type: DIAGNOSTIC_TEST

retinal imaging device

Intervention then Standard

Infant will undergo retinal imaging with Optos ultra-wide field retinal imaging device followed by standard method of examination with binocular indirect opthalmoscope (BIO).

Group Type: EXPERIMENTAL

Optos ultra-widefield retinal imaging (Optos California)

Intervention Type: DIAGNOSTIC_TEST

retinal imaging device

Interventions

Optos ultra-widefield retinal imaging (Optos California)

retinal imaging device

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospitals of Derby and Burton NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospitals of Derby & Burton NHS Foundation Trust

Derby, Derbyshire, United Kingdom

Countries

United Kingdom

Other Identifiers

DHRD/2017/043

Identifier Type: -

Identifier Source: org_study_id