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Retinopathy of Prematurity clinical trials

View clinical trials related to Retinopathy of Prematurity.

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NCT ID: NCT04539106 Completed - Clinical trials for Retinopathy of Prematurity

Intravitreal Ranibizumab in Recurrent ROP

Start date: June 1, 2019
Phase:
Study type: Observational

A retrospective study included reviewing of medical records of preterm babies who were admitted in neonatal intensive care unit (NICU) of Mansoura University children hospital (MUCH) or referred from nearby hospitals for ROP screening during the period from March 2013 to February 2020.

NCT ID: NCT04537065 Completed - Clinical trials for Retinopathy of Prematurity

Long Term Outcome of Intravitreal Ranibizumab for ROP

Start date: April 1, 2018
Phase:
Study type: Observational

premature infants who had a history of intravitreal injection of (Ranibizumab) not less than one year were examined for refractive state and biometry

NCT ID: NCT04463927 Completed - Pain Clinical Trials

The Effect of Non-nutritive Sucking on Pain During Examination for Retinopathy of Prematurity

Start date: May 10, 2020
Phase: N/A
Study type: Interventional

Aim: The aim of the study is to determine the effect of non-nutritive sucking on pain during examination for retinopathy of prematurity. Method: The study is conducted as a randomized controlled trial. The population of the study is premature newborn who treatment in a neonatal intensive unit. The premature newborns divided into two groups as an intervention and control group according to randomization. After the randomization, non-nutritive sucking is applied to the intervention group. No method is applied to the control group.

NCT ID: NCT04408807 Completed - Clinical trials for Retinopathy of Prematurity

Stress Induced by Screening for Retinopathy of Prematurity - Should Speculum and Indentation Rather be Avoided

stressROP
Start date: September 3, 2019
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04101721 Completed - Clinical trials for Retinopathy of Prematurity

Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity

BUTTERFLEYE
Start date: October 30, 2019
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to assess the efficacy of aflibercept compared to laser in patients diagnosed with retinopathy of prematurity (ROP). The secondary objectives of the study are to assess the need for a second treatment modality, to assess the recurrence of ROP in the study and to assess the safety and tolerability of aflibercept.

NCT ID: NCT04092127 Completed - Clinical trials for Retinopathy of Prematurity

Pain of Premature Babies and RetCam (DOLICAM)

DOLICAM
Start date: November 12, 2019
Phase:
Study type: Observational

It is a single-center prospective observational descriptive study. studied population is premature infants, hospitalized in the neonatology department of the University Hospital of Grenoble and for whom the RetCam examination is planned for screening for retinopathy of prematurity if they are at risk (prematurity <32 weeks). To measure their pain during the examination, it will be a matter of filming the face of the child for 15 seconds before the examination, then 2 times 30 seconds at two distinct times. The PIPP (Premature Infant Pain Profile) score includes a percentage of time on these 30 seconds where 3 items are found modified and a monitoring of heart rate and oxygen saturation.This time calculation can not be done live and requires video recording of the child's face during the exam. The statistical analyzes will be adjusted for sex, gestational age at birth, weight, and pain from birth (determined by the number of doses of level 1 analgesics received by the baby and the number of days (from birth to to the RetCam examination) when the baby received > level 1 analgesics).

NCT ID: NCT04004208 Completed - Clinical trials for Retinopathy of Prematurity (ROP)

Aflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy

FIREFLEYE
Start date: September 25, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate how well aflibercept works in babies with ROP, comparing it with laser therapy. The study also has the objective to demonstrate how safe aflibercept is when used in babies, and describe how the drug moves into, through and out of the body.

NCT ID: NCT03865134 Completed - Visual Impairment Clinical Trials

Evaluation of Visual - Motor Development in Children With Retinopathy of Prematurity

Start date: September 20, 2018
Phase:
Study type: Observational

The aim of this study was to investigate the eye structure, visual impairment, visual motor development and motor coordination of children between 2-6 ages that had applied to diod laser photocoagulation and intravitreal anti - vascular endothelial growth factor treatment.

NCT ID: NCT03830580 Completed - Prematurity Clinical Trials

Benefit of Singing in the Care of Premature Children Undergoing Screening for Retinopathy of Prematurity in the Neonatology and Neonatal Resuscitation Unit of the Dijon University Hospital

Voix Chantée
Start date: February 6, 2019
Phase: N/A
Study type: Interventional

As part of the regular procedure for premature births, premature infants undergo several screening examinations, including an examination of the fundus. This examination seeks to establish whether the infant has retinopathy of prematurity. This disease affects the vessels of the retina of the eye, especially in prematurely born children, and can lead to serious complications such as blindness if it is not treated in time. The purpose of this study is to assess the discomfort caused by the screening in order to improve practices. To do this, the investigators would like to evaluate whether soft auditory stimulation, more precisely a person singing, would improve the children's level of comfort during the examination. To do this, the participating children will be divided into 2 groups: - The "Singing" group will receive the usual comfort treatments (placed in a 'nest', pacifier and sugar water) and a trained professional will sing a lullaby or nursery rhyme at the same time - control group will receive the usual comfort care (placed in a 'nest', pacifier and sugar water) The child's head and entire body will be filmed, which will allow an evaluator to assess the child's comfort.

NCT ID: NCT03824782 Completed - Pain Clinical Trials

The Effect of Eyemasks on Neonatal Stress Following Dilated Retinal Examination

MASK-ROP
Start date: April 1, 2016
Phase: N/A
Study type: Interventional

Although screening exams for retinopathy of prematurity (ROP) prevent blindness they are physiologically stressful for infants. The investigators postulate that photosensitivity during mydriasis contributes to post-examination stress and that reducing light stimulation with a phototherapy mask can make infants more comfortable. The objective of this study is to determine the effect of a phototherapy mask worn during mydriasis on infant stress in the 12 hour period following ROP screening.