Retinopathy of PrematuritystressROPNCT04408807
Stress Induced by Screening for Retinopathy of Prematurity - Should Speculum and Indentation Rather be Avoided
A study testing Speculum-free (SpF) fundoscopy and Speculum (Sp) fundoscopy in people with Retinopathy of Prematurity, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
The purpose is to assess the hypothesis that indirect ophthalmoscopy for retinopathy of prematurity eye examination (ROPEE) screening without the use of a lid speculum and scleral indentation (speculum-free, SpF) is less painful/stressful than funduscopy with speculum (Sp) and scleral indentation. Read more about this study
- Who is it for?
- Ages 30 to 37 weeks
- Conditions the study is for
- Retinopathy of Prematurity
- What is being tested?
- Speculum-free (SpF) fundoscopy and Speculum (Sp) fundoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteGreece
- Study dates
- 3 Sep 2019to 27 Feb 2020
- 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 30 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm neonates undergoing screening for ROP, i.e.
- with GA < 32weeks and/or BW < 1501grams
- infants of greater BW and GA with increased comorbidity, e.g. sepsis, prolonged need for oxygen supplementation etc., as judged by the attending neonatologist
Who cannot join
- Severe clinical condition with unstable vital signs to the extent that stress is not desired and the examination need to be postponed.
- Diagnosis of traumatic apoptosis of the corneal epithelium / corneal ulcer.
- Neonates under sedative/analgesic treatment.
- Intraventricular hemorrhage (III,IV degree), moderate/severe neurological impairment, other conditions that could alter pain response.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose is to assess the hypothesis that indirect ophthalmoscopy for retinopathy of prematurity eye examination (ROPEE) screening without the use of a lid speculum and scleral indentation (speculum-free, SpF) is less painful/stressful than funduscopy with speculum (Sp) and scleral indentation.
Read the detailed description
A prospective randomized cross-over study was conducted for the comparison of the two techniques of funduscopy for ROPEE screening, i.e. with (Sp) or without (SpF) the use of a speculum and indentor. A random number table was used to allocate participants into either a) receiving Sp funduscopy on their first and SpF on their second screening examination a week later, or b) receiving SpF first and Sp a week later.
- Conditions
- Retinopathy of Prematurity
- Being tested
- Speculum-free (SpF) fundoscopy, Speculum (Sp) fundoscopy
- Medical subject headings
- Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speculum-free (SpF) fundoscopyOther
Indirect ophthalmoscopy without the use of eyelid speculum and scleral indentation
Speculum (Sp) fundoscopyOther
Indirect ophthalmoscopy with the use of eyelid speculum and scleral indentation
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | ROPEE screening with speculum-free fundoscopy Receives: Other: Speculum-free (SpF) fundoscopy |
| Control Group | Active comparator | ROPEE screening with speculum fundoscopy Receives: Other: Speculum (Sp) fundoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premature Infant Pain Profile-Revised score (PIPP)
Measured: a) before the intervention [the effect of mydriasis (PIPP1)] b) at the end of the intervention [the effect of funduscopy (PIPP2)] c) 10-20 minutes after the intervention [the overall effect of the examination, i.e. mydriasis and funduscopy (PIPP3)]
Secondary outcomes (4)
Crying score of the Bernese pain scale
Measured: During the examination
Adverse events including arrythmia/bradycardia, apnoea, increased oxygen demands and feed intolerance
Measured: During the examination and during the 24 hours after the examination
Adequacy of judging the presence of treatment-requiring ROP
Measured: At the end of ROPEE screening
Duration of fundoscopy
Measured: During the examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start3 Sep 2019
- Primary completion4 Feb 2020
- Study completion27 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asimina Mataftsi, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408807
- Sponsor's protocol ID
- 414/08-05-2019
- Acronym
- stressROP
- Status last verified
- Mar 2022
- First submitted
- 26 May 2020
- Last updated
- 24 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dhaliwal CA, Wright E, McIntosh N, Dhaliwal K, Fleck BW. Pain in neonates during screening for retinopathy of prematurity using binocular indirect ophthalmoscopy and wide-field digital retinal imaging: a randomised comparison. Arch Dis Child Fetal Neonatal Ed. 2010 Mar;95(2):F146-8. doi: 10.1136/adc.2009.168971. Epub 2009 Oct 8.
PubMed 19815939Mukherjee AN, Watts P, Al-Madfai H, Manoj B, Roberts D. Impact of retinopathy of prematurity screening examination on cardiorespiratory indices: a comparison of indirect ophthalmoscopy and retcam imaging. Ophthalmology. 2006 Sep;113(9):1547-52. doi: 10.1016/j.ophtha.2006.03.056. Epub 2006 Jul 7.
PubMed 16828505Mehta M, Adams GG, Bunce C, Xing W, Hill M. Pilot study of the systemic effects of three different screening methods used for retinopathy of prematurity. Early Hum Dev. 2005 Apr;81(4):355-60. doi: 10.1016/j.earlhumdev.2004.09.005. Epub 2004 Dec 8.
PubMed 15814220Dhillon B, Wright E, Fleck BW. Screening for retinopathy of prematurity: are a lid speculum and scleral indentation necessary? J Pediatr Ophthalmol Strabismus. 1993 Nov-Dec;30(6):377-81. doi: 10.3928/0191-3913-19931101-08.
PubMed 8120743Mataftsi A, Lithoxopoulou M, Seliniotaki AK, Talimtzi P, Oustoglou E, Diamanti E, Soubasi V, Ziakas N, Haidich AB. Avoiding use of lid speculum and indentation reduced infantile stress during retinopathy of prematurity examinations. Acta Ophthalmol. 2022 Feb;100(1):e128-e134. doi: 10.1111/aos.15085. Epub 2021 Dec 23.
PubMed 34939742
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Induced by Screening for Retinopathy of Prematurity - Should Speculum and Indentation Rather be Avoided
- ClinicalTrials.gov ID
- NCT04408807
- Acronym / sponsor ID
- stressROP / 414/08-05-2019
- Conditions
- Retinopathy of Prematurity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 4 Feb 2020 (actual)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 29 May 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.
The purpose is to assess the hypothesis that indirect ophthalmoscopy for retinopathy of prematurity eye examination (ROPEE) screening without the use of a lid speculum and scleral indentation (speculum-free, SpF) is less painful/stressful than funduscopy with speculum (Sp) and scleral indentation.
Detailed description
A prospective randomized cross-over study was conducted for the comparison of the two techniques of funduscopy for ROPEE screening, i.e. with (Sp) or without (SpF) the use of a speculum and indentor. A random number table was used to allocate participants into either a) receiving Sp funduscopy on their first and SpF on their second screening examination a week later, or b) receiving SpF first and Sp a week later.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Speculum-free (SpF) fundoscopyROPEE screening with speculum-free fundoscopy |
| Control Group | Active comparator | Other: Speculum (Sp) fundoscopyROPEE screening with speculum fundoscopy |
Who may qualify
- Ages
- 30 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm neonates undergoing screening for ROP, i.e.
- with GA < 32weeks and/or BW < 1501grams
- infants of greater BW and GA with increased comorbidity, e.g. sepsis, prolonged need for oxygen supplementation etc., as judged by the attending neonatologist
Key exclusion criteria (4 listed)
- Severe clinical condition with unstable vital signs to the extent that stress is not desired and the examination need to be postponed.
- Diagnosis of traumatic apoptosis of the corneal epithelium / corneal ulcer.
- Neonates under sedative/analgesic treatment.
- Intraventricular hemorrhage (III,IV degree), moderate/severe neurological impairment, other conditions that could alter pain response.
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 |
|---|---|---|
| Speculum-free (SpF) fundoscopyIndirect ophthalmoscopy without the use of eyelid speculum and scleral indentation | Other | Study Group |
| Speculum (Sp) fundoscopyIndirect ophthalmoscopy with the use of eyelid speculum and scleral indentation | Other | Control Group |
Primary outcome
Premature Infant Pain Profile-Revised score (PIPP)
Time frame: a) before the intervention [the effect of mydriasis (PIPP1)] b) at the end of the intervention [the effect of funduscopy (PIPP2)] c) 10-20 minutes after the intervention [the overall effect of the examination, i.e. mydriasis and funduscopy (PIPP3)]
4 secondary outcomes
Crying score of the Bernese pain scale
Time frame: During the examination
Adverse events including arrythmia/bradycardia, apnoea, increased oxygen demands and feed intolerance
Time frame: During the examination and during the 24 hours after the examination
Adequacy of judging the presence of treatment-requiring ROP
Time frame: At the end of ROPEE screening
Duration of fundoscopy
Time frame: During the examination
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 24 Mar 2022.
- Background: PubMed 19815939Dhaliwal CA, Wright E, McIntosh N, Dhaliwal K, Fleck BW. Pain in neonates during screening for retinopathy of prematurity using binocular indirect ophthalmoscopy and wide-field digital retinal imaging: a randomised comparison. Arch Dis Child Fetal Neonatal Ed. 2010 Mar;95(2):F146-8. doi: 10.1136/adc.2009.168971. Epub 2009 Oct 8.
- Background: PubMed 16828505Mukherjee AN, Watts P, Al-Madfai H, Manoj B, Roberts D. Impact of retinopathy of prematurity screening examination on cardiorespiratory indices: a comparison of indirect ophthalmoscopy and retcam imaging. Ophthalmology. 2006 Sep;113(9):1547-52. doi: 10.1016/j.ophtha.2006.03.056. Epub 2006 Jul 7.
- Background: PubMed 15814220Mehta M, Adams GG, Bunce C, Xing W, Hill M. Pilot study of the systemic effects of three different screening methods used for retinopathy of prematurity. Early Hum Dev. 2005 Apr;81(4):355-60. doi: 10.1016/j.earlhumdev.2004.09.005. Epub 2004 Dec 8.
- Background: PubMed 8120743Dhillon B, Wright E, Fleck BW. Screening for retinopathy of prematurity: are a lid speculum and scleral indentation necessary? J Pediatr Ophthalmol Strabismus. 1993 Nov-Dec;30(6):377-81. doi: 10.3928/0191-3913-19931101-08.
- Results publication: PubMed 34939742Mataftsi A, Lithoxopoulou M, Seliniotaki AK, Talimtzi P, Oustoglou E, Diamanti E, Soubasi V, Ziakas N, Haidich AB. Avoiding use of lid speculum and indentation reduced infantile stress during retinopathy of prematurity examinations. Acta Ophthalmol. 2022 Feb;100(1):e128-e134. doi: 10.1111/aos.15085. Epub 2021 Dec 23.
- Individual participant dataSharing planned: No
Related trials for Retinopathy of Prematurity
RecruitingObservational study
An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)
Retinopathy of Prematurity, Preterm Infants
RecruitingObservational study
The Correlation Between Red Cell Transfusion and Complications of Prematurity
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
RecruitingObservational study
Imaging Retinal Vasculature in Infant Eyes
Retinopathy of Prematurity
RecruitingPhase 1
Safety, PK and PD of FLQ-101 in Premature Neonates
Retinopathy of Prematurity (ROP)
Recruiting
Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care
Retinopathy of Prematurity (ROP)
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 Speculum-free (SpF) fundoscopy and Speculum (Sp) fundoscopy in people with Retinopathy of Prematurity, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 3 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 24 Mar 2022. 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 Greece. 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?
Premature Infant Pain Profile-Revised score (PIPP) (time frame: a) before the intervention [the effect of mydriasis (PIPP1)] b) at the end of the intervention [the effect of funduscopy (PIPP2)] c) 10-20 minutes after the intervention [the overall effect of the examination, i.e. mydriasis and funduscopy (PIPP3)]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04408807, which also lists 5 linked publications.
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 24 Mar 2022.