Retinopathy of Prematurity
Conditions
Brief summary
The proportion of infants with ROP progression to Type 1 ROP needing conventional treatment in each study arm.
Detailed description
1. Time from detection of proliferative ROP to Type 1 ROP, 2. Recurrences after laser/Anti-VEGF treatment in dexamethasone treatment and placebo arm, 3. Retinal morphology at 40 weeks PMA and at 2.5 and 6.5 years with optical coherence tomography (OCT), 4. Measurements of intraocular pressure before treatment at 1 and 2 weeks after start of treatment and after completed treatment and at 2.5 and 6.5 years of age, 5. Visual outcome and refractive errors at 2.5 and 6.5 years of age, 6. To analyse leftovers of blood from the clinical blood sampling with regard to selected biomarkers and their relation to ROP development and treatment effect
Interventions
DRUGDEXAFREE 1 mg/ml
DRUG"DROP-it" ögondroppar 5 ml Physiologic saline 0
DRUG9 % natriumklorid i 100 ml renat vatten
Sponsors
Vaestra Goetalandsregionen
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of infants with ROP progression to Type 1 ROP needing conventional treatment in each study arm. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time from detection of proliferative ROP to Type 1 ROP, 2. Recurrences after laser/Anti-VEGF treatment in dexamethasone treatment and placebo arm, 3. Retinal morphology at 40 weeks PMA and at 2.5 and 6.5 years with optical coherence tomography (OCT), 4. Measurements of intraocular pressure before treatment at 1 and 2 weeks after start of treatment and after completed treatment and at 2.5 and 6.5 years of age, 5. Visual outcome and refractive errors at 2.5 and 6.5 years of age, 6. To analyse leftovers of blood from the clinical blood sampling with regard to selected biomarkers and their relation to ROP development and treatment effect | — |
Countries
Sweden
Outcome results
None listed