The aim of the multicentre study is to investigate whether treatment with eye drops containing cortisone can reduce the proportion of children who require treatment (laser or Anti-VEGF) for severe retinopathy of prematurity (ROP). With the support of the digital platform HOPE Clinical Research from ADDI Medical, the utilisation of healthcare resources is optimised. The data collection process becomes both more efficient and more secure. The study will run for two years and include one hundred children born before gestational week thirty, from six different regions in Sweden.
Every year, twenty thousand premature babies in the world go blind due to the disease ROP. These children can suffer from retinal changes, known as retinopathy of prematurity. The blood vessels of the retina grow incorrectly, which can cause haemorrhages and scar tissue in the fundus of the eye. If this is not detected and treated in time, the children are at risk of going blind.
About a third of all infants born before thirty weeks of gestation are at risk of being diagnosed with ROP. The infants are examined regularly during the neonatal period, and approximately seven per cent of the examined infants develop abnormal blood vessels in the eye that require treatment to avoid blindness.
The standard treatment in Sweden for sight-threatening ROP is laser photocoagulation of the retina, but in recent years, medications (Anti-VEGF) injected into the eye have also started to be used. Treatment of severe ROP with laser is a destructive retinal treatment performed under general anaesthesia.
”If the cortisone drop treatment is successful, this will benefit our tiniest survivors; in several cases, we could avoid treatment for severe ROP. When treatment is avoided, the children do not need to be anaesthetised once or several times, which risks having a negative impact on their development. Treatment with cortisone eye drops would also be a major advantage in parts of the world where access to other treatment options is limited and many children go blind, perhaps unnecessarily, says Ann Hellström, Professor of Paediatric Ophthalmology at Queen Silvia Children's Hospital, who is responsible for the study.
”We are of course extremely proud that HOPE Clinical Research has been chosen for such an advanced and complicated multicentre study. This demonstrates that we have a secure and solid solution that not only offers a traditional Clinical Research System, but also acts as a hub for everyone involved throughout the entire study," says Nina Sellberg, CEO of ADDI Medical.
Through the support of robotisation, configured according to algorithms and trigger points from the researchers in the study, parents and staff are automatically guided step by step through the entire study process. The parents of the children will use and receive support via the patient app HOPE App, where they can both follow and actively participate in the entire study and treatment process. Through chat and video calls, the parents can also maintain close contact with the child's care team, Nina Sellberg continues.
Please read more about ADDI Medical's HOPE Clinical Research: https://www.addimedical.se/losningar/hope-clinical-research/