Retinopathy of Prematurity (ROP)NCT06775353
To Assess the Effect of Dexamethasone Eye Drops on the Retinopathy of Prematurity Outcome
An observational study of Retinopathy of Prematurity (ROP), run by Region Skane at 1 site in Sweden.
Trial summary
The purpose is to compare the treatment frequency of preterm infants who developed severe Retinopathy of Prematurity (ROP) during the years 2015-2018 with 2020-2021 in the country, using the statistical method 'difference in differences' to investigate the potential for scientific evidence regarding the introduction… Read more about this study
- Who is it for?
- Ages 31 weeks and olderHealthy volunteers can take part
- Conditions the study is for
- Retinopathy of Prematurity (ROP)
- What is being tested?
- Dexamethasone eyedrop
- How many people
- 2,017 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2022to 1 Jan 2025
- Phase
- Observational
- 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 31 weeks and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Between 2015-2018 and 2020-2021, all children born before week 30 in the Southern Healthcare Region and three other regions where dexamethasone eye drops were not used to prevent severe treatment-requiring ROP were included in the study population. A specific analysis was conducted on the children who developed severe ROP, Type 1 and Type 2 ROP.
Who may be able to join
- During 2015-2018 and 2020-2021, all children born before week 30 in the Southern Health Region and three regions where dexamethasone eye drops were not used to prevent severe treatment-requiring ROP were included
Who cannot join
- If a child has not completed the screening examinations for ROP-
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Clinical Sciences, Ophthalmology, Lund University, Skåne University Hospital, Lund, Sweden
Lund, Skåne County, 22185
About this study
Official title: The Effect of Dexamethasone Eye Drops on Retinopathy of Prematurity, a Swedish Registry-based Study
The purpose is to compare the treatment frequency of preterm infants who developed severe Retinopathy of Prematurity (ROP) during the years 2015-2018 with 2020-2021 in the country, using the statistical method 'difference in differences' to investigate the potential for scientific evidence regarding the introduction of dexamethasone eye drops' effect on the development of severe treatment-requiring ROP. During these years, the investigatots assess that the recommended oxygen saturation levels for preterm infants have remained stable at each clinic, which will serve as its own reference.
Read the detailed description
Retinopathy of Prematurity (ROP) can develop in premature infants and involves abnormal growth of blood vessels in the retina. It can lead to severe visual impairment or blindness if not treated in time. In Sweden, approximately 40-50 children require treatment for severe ROP each year. Children at the highest risk are screened to detect ROP at an early stage, and, if necessary, laser treatment of the retina is performed or an injection of an anti-vascular endothelial growth factor (anti-VEGF) agent is administered. However, laser treatment burns away the outermost part of the retina, and anti-VEGF carries a significant risk of recurring treatment needs, resulting in increased anesthesia and examination sessions for the child, risk of eye infection, lens damage, and uncertainty about the drug's broader effects on the child's brain or body.
Dexamethasone is a corticosteroid commonly used in eye drop form to treat inflammatory and angiogenic eye diseases. Dexamethasone is also administered systemically in neonatal care to treat lung disease and wean premature infants off ventilator support, often in relatively high doses early in the infant's life.
Increased inflammation in the eyes has been reported in ROP. According to both national and several international guidelines, dexamethasone eye drops are administered in tapering doses after laser treatment for severe ROP, often staring with 1 drop 3 times daily. When a child begins developing severe ROP, it is classified as Type-1 ROP and Type-2 ROP. Type-1 ROP requires treatment within 72 hours, while Type-2 ROP is considered a precursor to Type-1 ROP.
In the Southern Healthcare Region of Sweden, the investigators have initiated earlier use of low dose dexamethasone eye drops, specifically when it appears that the child is transitioning from Type-2 ROP to Type-1 ROP. Usually 1 drop daily. In a pilot study published in September 2021, the investigators observed that only 24% of children who received dexamethasone eye drops at Type-2 ROP progressed to Type-1 ROP, compared to 74% of children who did not receive dexamethasone eye drops for the same type of ROP.
In Sweden, there is a national quality registry for ROP care, SWEDROP, with approximately 98% coverage. The investigators now aim to conduct a study based on this quality registry and compare the results from the Southern Healthcare Region with other regions in Sweden that have not used dexamethasone for Type-2 ROP. The goal is to determine whether the "difference-in-differences" method can provide stronger scientific evidence supporting this treatment approach. The plan is to compare the number of children who progressed to laser treatment in the years before the introduction of dexamethasone for Type-2 ROP with data from 2020-2021, when almost all children in the Southern Healthcare Region, received dexamethasone for Type-2 ROP. Specifically, the investigators will compare the years 2015-2018 with 2020-2021. The year 2019 served as a transitional period in the Southern Healthcare Region, where children were treated with varying doses, and therefore it will not be included in the primary comparison. The treatment frequency will be analyzed both for all screened children and specifically for those who developed severe ROP. Severe ROP is defined as type 1 and type 2 ROP.
Age at treatment will also be analyzed.
- Conditions
- Retinopathy of Prematurity (ROP)
- Being tested
- Dexamethasone eyedrop
- Keywords
- topical dexamethasone
- 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.
Dexamethasone eyedropDrug
Infants who developed stages of pretreatment-requiring severe ROP were usually given one eyedrop of dexamethasone daily until the ROP changes regressed.
| Study group | Role | What they receive |
|---|---|---|
| all screened infants for ROP borne before week 30 in four swedish regions | The treatment frequency for severe ROP was compared between the control years 2015-2018 and the intervention years 2020-2021, but also for all children screened during these years. One region introduced dexamethasone eye drops during the intervention years. The other three regions did not and thus served as a control group. Receives: Drug: Dexamethasone eyedrop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Show the clinical effect of dexamethasone eyedrops in reducing treatment-requiring severe ROP
Has the treatment frequency of severe ROP decreased in the Southern healthcare region compared to other healthcare regions after the introduction of early low-dose corticosteroid treatment in the form of eye drops? Treatment frequency will also be analyzed for all children screened during these years. The statistical method difference in differences will be used in the analyses.
Age at treatment will also be studied to see if the cortisone drops affect this factor.
Measured: The treatment frequency was compared for the intervention group with the control group during the control years 2015-2018 and the intervention years 2020-2021 when dexamethasone eye drops were introduced in the intervention group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start1 Dec 2022
- Primary completion31 Dec 2024
- Study completion1 Jan 2025
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 Prematurity (ROP)Studies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,017 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775353
- Sponsor's protocol ID
- 2022-05824-01
- Status last verified
- Jan 2025
- First submitted
- 9 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rivera JC, Holm M, Austeng D, Morken TS, Zhou TE, Beaudry-Richard A, Sierra EM, Dammann O, Chemtob S. Retinopathy of prematurity: inflammation, choroidal degeneration, and novel promising therapeutic strategies. J Neuroinflammation. 2017 Aug 22;14(1):165. doi: 10.1186/s12974-017-0943-1.
PubMed 28830469Doyle LW, Cheong JL, Ehrenkranz RA, Halliday HL. Early (< 8 days) systemic postnatal corticosteroids for prevention of bronchopulmonary dysplasia in preterm infants. Cochrane Database Syst Rev. 2017 Oct 24;10(10):CD001146. doi: 10.1002/14651858.CD001146.pub5.
PubMed 29063585Chiang MF, Quinn GE, Fielder AR, Ostmo SR, Paul Chan RV, Berrocal A, Binenbaum G, Blair M, Peter Campbell J, Capone A Jr, Chen Y, Dai S, Ells A, Fleck BW, Good WV, Elizabeth Hartnett M, Holmstrom G, Kusaka S, Kychenthal A, Lepore D, Lorenz B, Martinez-Castellanos MA, Ozdek S, Ademola-Popoola D, Reynolds JD, Shah PK, Shapiro M, Stahl A, Toth C, Vinekar A, Visser L, Wallace DK, Wu WC, Zhao P, Zin A. International Classification of Retinopathy of Prematurity, Third Edition. Ophthalmology. 2021 Oct;128(10):e51-e68. doi: 10.1016/j.ophtha.2021.05.031. Epub 2021 Jul 8.
PubMed 34247850Holmstrom G, Hellstrom A, Granse L, Saric M, Sunnqvist B, Wallin A, Tornqvist K, Larsson E. New modifications of Swedish ROP guidelines based on 10-year data from the SWEDROP register. Br J Ophthalmol. 2020 Jul;104(7):943-949. doi: 10.1136/bjophthalmol-2019-314874. Epub 2019 Nov 1.
PubMed 31676594Ohnell HM, Andreasson S, Granse L. Dexamethasone Eye Drops for the Treatment of Retinopathy of Prematurity. Ophthalmol Retina. 2022 Feb;6(2):181-182. doi: 10.1016/j.oret.2021.09.002. Epub 2021 Sep 10. No abstract available.
PubMed 34517147
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexamethasone Eye Drops on Retinopathy of Prematurity, a Swedish Registry-based Study
- ClinicalTrials.gov ID
- NCT06775353
- Acronym / sponsor ID
- 2022-05824-01
- Conditions
- Retinopathy of Prematurity (ROP)
- Keywords
- topical dexamethasone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,017 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 15 Jan 2025 (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 compare the treatment frequency of preterm infants who developed severe Retinopathy of Prematurity (ROP) during the years 2015-2018 with 2020-2021 in the country, using the statistical method 'difference in differences' to investigate the potential for scientific evidence regarding the introduction of dexamethasone eye drops' effect on the development of severe treatment-requiring ROP. During these years, the investigatots assess that the recommended oxygen saturation levels for preterm infants have remained stable at each clinic, which will serve as its own reference.
Detailed description
Retinopathy of Prematurity (ROP) can develop in premature infants and involves abnormal growth of blood vessels in the retina. It can lead to severe visual impairment or blindness if not treated in time. In Sweden, approximately 40-50 children require treatment for severe ROP each year. Children at the highest risk are screened to detect ROP at an early stage, and, if necessary, laser treatment of the retina is performed or an injection of an anti-vascular endothelial growth factor (anti-VEGF) agent is administered. However, laser treatment burns away the outermost part of the retina, and anti-VEGF carries a significant risk of recurring treatment needs, resulting in increased anesthesia and examination sessions for the child, risk of eye infection, lens damage, and uncertainty about the drug's broader effects on the child's brain or body.
Dexamethasone is a corticosteroid commonly used in eye drop form to treat inflammatory and angiogenic eye diseases. Dexamethasone is also administered systemically in neonatal care to treat lung disease and wean premature infants off ventilator support, often in relatively high doses early in the infant's life.
Increased inflammation in the eyes has been reported in ROP. According to both national and several international guidelines, dexamethasone eye drops are administered in tapering doses after laser treatment for severe ROP, often staring with 1 drop 3 times daily. When a child begins developing severe ROP, it is classified as Type-1 ROP and Type-2 ROP. Type-1 ROP requires treatment within 72 hours, while Type-2 ROP is considered a precursor to Type-1 ROP.
In the Southern Healthcare Region of Sweden, the investigators have initiated earlier use of low dose dexamethasone eye drops, specifically when it appears that the child is transitioning from Type-2 ROP to Type-1 ROP. Usually 1 drop daily. In a pilot study published in September 2021, the investigators observed that only 24% of children who received dexamethasone eye drops at Type-2 ROP progressed to Type-1 ROP, compared to 74% of children who did not receive dexamethasone eye drops for the same type of ROP.
In Sweden, there is a national quality registry for ROP care, SWEDROP, with approximately 98% coverage. The investigators now aim to conduct a study based on this quality registry and compare the results from the Southern Healthcare Region with other regions in Sweden that have not used dexamethasone for Type-2 ROP. The goal is to determine whether the "difference-in-differences" method can provide stronger scientific evidence supporting this treatment approach. The plan is to compare the number of children who progressed to laser treatment in the years before the introduction of dexamethasone for Type-2 ROP with data from 2020-2021, when almost all children in the Southern Healthcare Region, received dexamethasone for Type-2 ROP. Specifically, the investigators will compare the years 2015-2018 with 2020-2021. The year 2019 served as a transitional period in the Southern Healthcare Region, where children were treated with varying doses, and therefore it will not be included in the primary comparison. The treatment frequency will be analyzed both for all screened children and specifically for those who developed severe ROP. Severe ROP is defined as type 1 and type 2 ROP.
Age at treatment will also be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all screened infants for ROP borne before week 30 in four swedish regions | – | Drug: Dexamethasone eyedropThe treatment frequency for severe ROP was compared between the control years 2015-2018 and the intervention years 2020-2021, but also for all children screened during these years. One region introduced dexamethasone eye drops during the intervention years. The other three regions did not and thus served as a control group. |
Who may qualify
- Ages
- 31 weeks and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Between 2015-2018 and 2020-2021, all children born before week 30 in the Southern Healthcare Region and three other regions where dexamethasone eye drops were not used to prevent severe treatment-requiring ROP were included in the study population. A specific analysis was conducted on the children who developed severe ROP, Type 1 and Type 2 ROP.
Key inclusion criteria (1 listed)
- During 2015-2018 and 2020-2021, all children born before week 30 in the Southern Health Region and three regions where dexamethasone eye drops were not used to prevent severe treatment-requiring ROP were included
Key exclusion criteria (1 listed)
- If a child has not completed the screening examinations for ROP-
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 |
|---|---|---|
| Dexamethasone eyedropInfants who developed stages of pretreatment-requiring severe ROP were usually given one eyedrop of dexamethasone daily until the ROP changes regressed. | Drug | all screened infants for ROP borne before week 30 in four swedish regions |
Primary outcome
Show the clinical effect of dexamethasone eyedrops in reducing treatment-requiring severe ROP
Time frame: The treatment frequency was compared for the intervention group with the control group during the control years 2015-2018 and the intervention years 2020-2021 when dexamethasone eye drops were introduced in the intervention group.
Has the treatment frequency of severe ROP decreased in the Southern healthcare region compared to other healthcare regions after the introduction of early low-dose corticosteroid treatment in the form of eye drops? Treatment frequency will also be analyzed for all children screened during these years. The statistical method difference in differences will be used in the analyses. Age at treatment will also be studied to see if the cortisone drops affect this factor.
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 22 Jan 2025.
- Background: PubMed 28830469Rivera JC, Holm M, Austeng D, Morken TS, Zhou TE, Beaudry-Richard A, Sierra EM, Dammann O, Chemtob S. Retinopathy of prematurity: inflammation, choroidal degeneration, and novel promising therapeutic strategies. J Neuroinflammation. 2017 Aug 22;14(1):165. doi: 10.1186/s12974-017-0943-1.
- Background: PubMed 29063585Doyle LW, Cheong JL, Ehrenkranz RA, Halliday HL. Early (< 8 days) systemic postnatal corticosteroids for prevention of bronchopulmonary dysplasia in preterm infants. Cochrane Database Syst Rev. 2017 Oct 24;10(10):CD001146. doi: 10.1002/14651858.CD001146.pub5.
- Background: PubMed 34247850Chiang MF, Quinn GE, Fielder AR, Ostmo SR, Paul Chan RV, Berrocal A, Binenbaum G, Blair M, Peter Campbell J, Capone A Jr, Chen Y, Dai S, Ells A, Fleck BW, Good WV, Elizabeth Hartnett M, Holmstrom G, Kusaka S, Kychenthal A, Lepore D, Lorenz B, Martinez-Castellanos MA, Ozdek S, Ademola-Popoola D, Reynolds JD, Shah PK, Shapiro M, Stahl A, Toth C, Vinekar A, Visser L, Wallace DK, Wu WC, Zhao P, Zin A. International Classification of Retinopathy of Prematurity, Third Edition. Ophthalmology. 2021 Oct;128(10):e51-e68. doi: 10.1016/j.ophtha.2021.05.031. Epub 2021 Jul 8.
- Background: PubMed 31676594Holmstrom G, Hellstrom A, Granse L, Saric M, Sunnqvist B, Wallin A, Tornqvist K, Larsson E. New modifications of Swedish ROP guidelines based on 10-year data from the SWEDROP register. Br J Ophthalmol. 2020 Jul;104(7):943-949. doi: 10.1136/bjophthalmol-2019-314874. Epub 2019 Nov 1.
- Background: PubMed 34517147Ohnell HM, Andreasson S, Granse L. Dexamethasone Eye Drops for the Treatment of Retinopathy of Prematurity. Ophthalmol Retina. 2022 Feb;6(2):181-182. doi: 10.1016/j.oret.2021.09.002. Epub 2021 Sep 10. No abstract available.
- 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?
An observational study of Retinopathy of Prematurity (ROP), run by Region Skane at 1 site in Sweden.
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 1 inclusion and 1 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 22 Jan 2025. 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 Sweden. 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?
Show the clinical effect of dexamethasone eyedrops in reducing treatment-requiring severe ROP (time frame: The treatment frequency was compared for the intervention group with the control group during the control years 2015-2018 and the intervention years 2020-2021 when dexamethasone eye drops were introduced in the intervention group.). 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 NCT06775353, 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 22 Jan 2025.