Pre-TermNCT04292015
Optos Versus Indirect Ophthalmoscopy for ROP Screening Examination (Optos vs BIO Study)
A study testing Optos ultra-widefield retinal imaging (Optos California) in people with Pre-Term, run by University Hospitals of Derby and Burton NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pre-Term
- What is being tested?
- Optos ultra-widefield retinal imaging (Optos California)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Aug 2017to 22 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals of Derby & Burton NHS Foundation Trust
Derby, Derbyshire, DE22 3DT
About this study
Official title: Impact of Retinopathy of Prematurity Screening Examination on Cardiorespiratory Indices - A Comparison of Optos Ultra-Widefield Retinal Imaging and Binocular Indirect Ophthalmoscopy
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.
Read the 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
- Being tested
- Optos ultra-widefield retinal imaging (Optos California)
- Keywords
- opthalmology, neonatal, premature
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optos ultra-widefield retinal imaging (Optos California)Diagnostic test
retinal imaging device
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Diagnostic Test: Optos ultra-widefield retinal imaging (Optos California) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure (BP)
Blood pressure (BP)
Measured: Baseline to 10 minutes following completion of both interventions
Number of infants that develop bradycardia
Defined as less than 100 beats per minute
Measured: Baseline to 10 minutes following completion of both interventions
Oxygen saturation
Number of infants who develop oxygen saturations below 85%
Measured: 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
Measured: Baseline to 10 minutes following completion of both interventions
Secondary outcomes (1)
Determine and compare time taken to perform interventions
Time of each intervention recorded
Measured: During intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start14 Aug 2017
- Primary completion22 Jan 2018
- Study completion22 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-TermStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292015
- Sponsor's protocol ID
- DHRD/2017/043
- Status last verified
- Feb 2020
- First submitted
- 26 Feb 2020
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Retinopathy of Prematurity Screening Examination on Cardiorespiratory Indices - A Comparison of Optos Ultra-Widefield Retinal Imaging and Binocular Indirect Ophthalmoscopy
- ClinicalTrials.gov ID
- NCT04292015
- Acronym / sponsor ID
- DHRD/2017/043
- Conditions
- Pre-Term
- Keywords
- opthalmology, neonatal, premature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation TrustUniversity, hospital or other
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 22 Jan 2018 (actual)
- Study completion
- 22 Jan 2018 (actual)
- First posted
- 2 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard then Intervention | Experimental | Diagnostic Test: Optos ultra-widefield retinal imaging (Optos California)Infant will undergo standard method of examination with binocular indirect opthalmoscope (BIO) followed by retinal imaging with Optos ultra-wide field retinal imaging device. |
| Intervention then Standard | Experimental | Diagnostic Test: Optos ultra-widefield retinal imaging (Optos California)Infant will undergo retinal imaging with Optos ultra-wide field retinal imaging device followed by standard method of examination with binocular indirect opthalmoscope (BIO). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optos ultra-widefield retinal imaging (Optos California)retinal imaging device | Diagnostic test | Intervention then Standard, Standard then Intervention |
Primary outcome
Blood pressure (BP)
Time frame: Baseline to 10 minutes following completion of both interventions
Blood pressure (BP)
Number of infants that develop bradycardia
Time frame: Baseline to 10 minutes following completion of both interventions
Defined as less than 100 beats per minute
Oxygen saturation
Time frame: Baseline to 10 minutes following completion of both interventions
Number of infants who develop oxygen saturations below 85%
Development of respiratory distress
Time frame: Baseline to 10 minutes following completion of both interventions
Number of infacnts who develop respiratory distress, defined as respiratory rate less than 30 breaths per minute
1 secondary outcome
Determine and compare time taken to perform interventions
Time frame: During intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optos ultra-widefield retinal imaging (Optos California) in people with Pre-Term, run by University Hospitals of Derby and Burton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (BP) (time frame: Baseline to 10 minutes following completion of both interventions). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2020; AzTrials last refreshed its copy on 2 Nov 2026.