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Retinopathy of Prematurity clinical trials

View clinical trials related to Retinopathy of Prematurity.

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NCT ID: NCT05133999 Recruiting - Clinical trials for Retinopathy of Prematurity

Iron and Retinopathy of Prematurity (ROP)

Fer-ROP
Start date: April 28, 2022
Phase:
Study type: Observational

The purpose of this study is to determine whether increased transferrin saturation in plasma (that reflects iron overload and/or low transferrin) is an independent risk factor for ROP development and severity. Preterm infants born at <31 week's post-menstrual age (PMA) or ≤1250g of birth weight will be included. Iron parameters in plasma will be measured during the first month of life. Retinopathy of prematurity (ROP) will be screened as currently recommended. The relationship between plasma iron parameters and ROP development and/or severity will be established.

NCT ID: NCT05132257 Recruiting - Clinical trials for Retinopathy of Prematurity

Genetic Polymorphism and Retinopathy of Prematurity: Correlation of Clinical Presentations and Severity

Start date: April 12, 2021
Phase:
Study type: Observational [Patient Registry]

Study Aim and Goals 1. Evaluate the correlation between genetic polymorphism and ROP development 2. To study the possibility if there are any specific genetic polymorphisms that lead to poor outcome or recurrence of ROP after treatment.

NCT ID: NCT05100212 Recruiting - Clinical trials for Retinopathy of Prematurity

umBilical Or Adult Donor Red Blood Cells in Extremely Low Gestational Age Neonates and Retinopathy of Prematurity (BORN)

BORN
Start date: December 1, 2021
Phase: Phase 2
Study type: Interventional

Extremely low gestational age neonates (ELGAN, i.e., born before 28 gestation weeks) are among the most heavily transfused pediatric patients. In this clinical setting, repeated red blood cell (RBC) transfusions independently predict a poor outcome, with a higher risk for mortality and morbidity. Recent studies from our own and other groups highlighted a close association between low levels of fetal hemoglobin (HbF) and severity of retinopathy of prematurity (ROP) and bronchopulmonary dysplasia (BPD), two disabilities that frequently complicate preterm birth. This association is not surprising, considering that 1) preterm neonates have a highly immature antioxidant reserve and both ROP and BPD rely on the oxidative damage as underlying mechanism; 2) in comparison with HbA, HbF is endowed with higher oxygen affinity, greater redox potential, higher tetrameric stability, and higher ability to generate unbound nitric oxide, all functions potentially protective in presence of an oxidative challenge; 3) in normal prenatal life, developing organ and tissues are exposed exclusively to HbF until last weeks of gestation; 4) in preterm neonates, the switch of the synthesis from HbF to HbA occurs around their due date, i.e., several weeks after the premature birth; 5) when preterm neonates receive transfusions, their tissues are abruptly exposed to high levels of HbA. We have recently run a pilot trial demonstrating as a proof-of-concept that transfusing cord blood red blood cell concentrates (CB-RBC) effectively prevents or restrains the HbF loss consequent to adult donor standard transfusions (A-RBC). This study explores the hypothesis that transfusing CB-RBCs instead of A-RBC may lower the incidence of severe ROP in ELGANs needing transfusions.

NCT ID: NCT05099588 Completed - Clinical trials for Retinopathy of Prematurity

The Incidence of Treatment-requiring Retinopathy of Prematurity in Greece

GR-ROP
Start date: June 1, 2020
Phase:
Study type: Observational

A prospective observational study of the incidence of treatment-requiring ROP (TR-ROP), at a national level, in Greece.

NCT ID: NCT05043077 Completed - Clinical trials for Retinopathy of Prematurity

Efficacy and Safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening

MyMiROPS
Start date: September 7, 2021
Phase: Phase 4
Study type: Interventional

The purpose is to test the hypothesis that microdrop instillation of combined phenylephrine 1.67% and tropicamide 0.33% eyedrops causes at least equal mydriasis compared with standard drop instillation of the same mydriatic regimen, which constitutes routine care for pupil dilation during retinopathy of prematurity (ROP) screening in our neonatal intensive care unit. Comparison, also, will be made to the subsequent adverse events and the drug concentration in peripheral blood samples.

NCT ID: NCT05033106 Recruiting - Clinical trials for Retinopathy of Prematurity Both Eyes

Ranibizumab Vs Bevacizumab for Type 1 Retinopathy of Prematurity

Start date: September 1, 2020
Phase: Phase 3
Study type: Interventional

Retinopathy of prematurity (ROP) with inadequate growth and development of retinal blood vessels in premature infants is one of the foremost reasons for childhood blindness. Recently there is a shift of treatment to VEGF inhibitors which can regress ROP without destroying the peripheral retina. Yet, the best drug has not been identified.Bevacizumab is a larger, full-length immunoglobulin G (IgG) molecule with slower retinal clearance and therefore prolonged diffusion into the systemic circulation, up to 3 weeks. In contrast, the systemic half-life of a Fab molecule, such as ranibizumab, is a few hours. The objective is to compare the efficacy and reliability of intravitreal bevacizumab with standard 0.625 mg dose and intravitreal ranibizumab treatments for type 1 ROP, namely pattern of disease regression, recurrence of ROP, necessity of subsequent ablative procedures.

NCT ID: NCT05010252 Recruiting - Quality of Life Clinical Trials

The Effect of Cycled Light on Premature Infants and Mothers

Start date: April 16, 2021
Phase: N/A
Study type: Interventional

Irregular lighting and lack of light in premature infants will affect their health, produce negative effects such as physiological and visual development, and also affect the mother's sleep and quality of life. This study is to verify the effect and delay effect of two-week premature infants' light intervention on their physiological indicators and visual development, mother's sleep quality and quality of life. It is planned to be in the Neonatal Moderate to Severe Ward of National Taiwan University Children's Hospital, and the subjects are premature babies born 32 weeks old. Divided into two groups of light intervention group and control group, longitudinal tracking intervention effect and six-week and three-month delay effect.

NCT ID: NCT04995341 Recruiting - Clinical trials for Retinopathy of Prematurity

Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2)

BabySTEPS2
Start date: August 16, 2021
Phase: N/A
Study type: Interventional

Retinopathy of prematurity (ROP) is a disorder of development of the neural retina and its vasculature that can impact vision in vulnerable preterm neonates for a lifetime. This study tests high-speed optical coherence tomography (OCT) technology compared to conventional color photographs at the bedside of very preterm infants in the intensive care nursery, to characterize previously unseen abnormalities that can predict a need for referral for ROP treatment, or poor visual or neurological development later in life, up to pre-school age. Our long-term goal is to help improve preterm infant health and vision via objective bedside imaging and analysis that characterizes early critical indicators of ROP, and poor visual function and neurological development, which will rapidly translate to better early intervention and improved future care.

NCT ID: NCT04985448 Enrolling by invitation - Clinical trials for Retinopathy of Prematurity

Real World Study of the Effectiveness and Safety of Conbercept Ophthalmic Injection in the Treatment of Retinopathy of Prematurity - Multicenter, Retrospective and Observational Study Based on Real World Data

Start date: September 2022
Phase:
Study type: Observational

This study is a retrospective, multi-center real world study. The real world data comes from the electronic medical record system and disease database of the research centers .The patient's demographic information, disease information, clinical treatment status, efficacy evaluation and adverse events and so on will be collected and evaluated by applicability of the data, generated an analysis data set. Use the causal inference method of statistical analysis to observe the effectiveness and safety of intravitreal injection of Conbercept, and explore the effectiveness and safety of different doses in the treatment of retinopathy of prematurity.

NCT ID: NCT04939571 Recruiting - Clinical trials for Retinopathy of Prematurity

European Disease Registry on Retinopathy of Prematurity (ROP)

EU-ROP
Start date: August 6, 2021
Phase:
Study type: Observational [Patient Registry]

The EU-ROP registry is a European wide multicenter non-interventional observational registry study intended to run open-ended in as many countries as possible including infants treated for retinopathy of prematurity irrespective of the used treatment modality. The registry is strictly observational; only clinical routine data is collected, no study-specific examinations or interventions are to be performed. The aim of the EU-ROP registry is to collect information on as many patients as possible treated for ROP in Europe. Both the number of study centers as well as the number of patients to be included into the registry are not limited. The primary objective is to describe the typical clinical features of infants with severe ROP, variations in phenotype, and the clinical progression of the disease over time (natural history) in different European countries as well as to study treatment patterns, follow-up patterns, as well as long-term outcomes.