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

NCT04292015 | Completed

• 1 other identifier: DHRD/2017/043
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-Term

Keywords

opthalmology; neonatal; premature

Outcome Measures

Primary Outcomes (4)

• Blood pressure (BP)

  Blood pressure (BP)

  Baseline to 10 minutes following completion of both interventions

• Number of infants that develop bradycardia

  Defined as less than 100 beats per minute

  Baseline to 10 minutes following completion of both interventions

• Oxygen saturation

  Number of infants who develop oxygen saturations below 85%

  Baseline to 10 minutes following completion of both interventions

• 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 Outcomes (1)

• Determine and compare time taken to perform interventions

  During intervention

Study Arms (2)

Standard then Intervention

EXPERIMENTAL

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

Diagnostic Test: Optos ultra-widefield retinal imaging (Optos California)

Intervention then Standard

EXPERIMENTAL

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

Diagnostic Test: Optos ultra-widefield retinal imaging (Optos California)

Interventions

Optos ultra-widefield retinal imaging (Optos California) DIAGNOSTIC_TEST

retinal imaging device

Intervention then Standard; Standard then Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospitals of Derby and Burton NHS Foundation Trust: lead

Study Sites (1)

University Hospitals of Derby & Burton NHS Foundation Trust

Derby, Derbyshire, DE22 3DT, United Kingdom

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each premature infant recruited into the study will undergo retinal imaging with the Optos ultra-widefield retinal imaging device as well as the gold standard method of examination with the binocular indirect ophthalmoscope. The order of the procedures to be carried out in each infant will be determined by randomisation via sealed envelopes prepared remotely by a member of the pilot team not involved in the recruitment of patients or their screenings.

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: March 2, 2020
• Study Start: August 14, 2017
• Primary Completion: January 22, 2018
• Study Completion: January 22, 2018
• Last Updated: March 2, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)