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Retinopathy of Prematurity clinical trials

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NCT ID: NCT05152862 Completed - Clinical trials for Retinopathy of Prematurity

Improve Screening Criteria for Retinopathy of Prematurity in Two French Center

DEREP3
Start date: March 21, 2022
Phase:
Study type: Observational

The aim of the study is to assess whether a delay of the first examination can be safely considered in French population. Secondary objectives are to describe retinopathy of prematurity (ROP) in a population of premature from two French tertiary NICU and to identify co-morbidities associated with the development of severe ROP.

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: NCT04883931 Completed - Clinical trials for Retinopathy of Prematurity

Mother Milk as a Eye Drop & Premature Retinopathy

Start date: May 6, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the effect of using breast milk as eye drops on ROP (Retinopathy of prematurity) disease observed in less then 32 weeks gestational age preterm babies.

NCT ID: NCT04838665 Completed - Clinical trials for Retinopathy of Prematurity

Changes in Vital Signs and Pupil Diameter Related to Pharmacologic Mydriasis in Premature Infants: A Randomized Double Blind Clinical Study

Start date: September 30, 2011
Phase: Phase 4
Study type: Interventional

Retinopathy of prematurity (ROP) is one of the common anatomic causes of blindness among Filipinos, accounting for 47.7% of the cases. With this retinopathy being preventable and treatable, ROP screening has been proven to be effective in preventing blindness, which is achieved with the usage of mydriatics. Even if the regimen of multiple alternate instillations of 0.5% tropicamide and 2.5% phenylephrine is the one recommended by international guidelines for ROP screening, the mydriatic regimen used by many of the country's institutions is the single instillation of 0.5% tropicamide + 0.5% phenylephrine applied via a cotton wick placed in the inferior fornix (SIW). There have been no studies yet on the safety and efficacy in premature infants of this mydriatic preparation and method, although it is hypothesized that the usage of a cotton wick promotes the possible systemic effects of the mydriatic combination used. This study then aims to determine the safety and efficacy of different mydriatic regimens in premature infants referred for screening of ROP using (1) multiple alternate instillations of 0.5% cyclopentolate hydrochloride and 2.5% phenylephrine (MAI), (2) single instillation of 0.5% tropicamide + 0.5% phenylephrine (SI), and (3) single instillation of 0.5% tropicamide + 0.5% phenylephrine with a cotton wick placed in the inferior fornix (SIW) in a tertiary Philippine hospital. This study was designed as a randomized, double blind, clinical study which enrolled sixty preterm infants referred for ROP Screening from January to July 2011. With instillations via MAI, SI, and SIW, systolic blood pressure (SBP), diastolic pressure (DBP), mean arterial pressure (MAP), heart rate, and oxygen saturation were monitored from ten minutes prior to instillation up to forty-five minutes after instillation. Pupil dilations were also measured at the forty-fifth minute.

NCT ID: NCT04767178 Completed - Pain Management Clinical Trials

Pain Management During Screening for Retinopathy of Prematurity

Start date: January 1, 2020
Phase:
Study type: Observational

Abstract Background: Screening examinations for retinopathy of prematurity (ROP) is critical to reduce ROP-related vision loss, however, the procedure is painful and uncomfortable, and topical anesthetics do not completely suppress the painful responses. The number of safe and effective pharmacological options to reduce pain during eye examinations for ROP screening in preterm infants is limited. Objective: This study compared the efficacy of oral ibuprofen and oral paracetamol in reducing pain during screening for ROP in preterm infants. Design: This prospective observational study was conducted at a tertiary-care neonatal intensive care units. Forty-four preterm infants with gestational age ≤ 32 weeks undergoing ROP screening were included. Each enrolled infant received either oral ibuprofen 10 mg/kg (n = 22) or oral paracetamol 10 mg/kg (n = 22) one hour before eye examination. The primary outcome measure was pain assessed by the Neonatal Pain, Agitation, and Sedation (N-PASS) scale. Secondary outcome measures were tachycardia, bradycardia, desaturations, and crying time.

NCT ID: NCT04623684 Completed - Clinical trials for Retinopathy of Prematurity

Efficacy and Safety of Mydriatic Microdrops Compared With Standard Drops for Retinopathy of Prematurity (ROP) Screening: a Pilot Randomized Clinical Trial

Start date: March 24, 2020
Phase: Phase 4
Study type: Interventional

The purpose is to assess whether the use of microdrop instillation of phenylephrine 1.67% and tropicamide 0.33% maintains mydriatic efficacy while presents an improved safety profile compared with standard drops of phenylephrine 1.67% and tropicamide 0.33%, which is routine care for pupil dilation during retinopathy of prematurity (ROP) screening in our neonatal intensive care unit.

NCT ID: NCT04621136 Completed - Clinical trials for Retinopathy of Prematurity

PhaseI/II Investigator-Initiated Trial to Investigate Safety and Efficacy of Ripasudil in Patients With Retinopathy of Prematurity

Start date: November 1, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, single-arm phase I/II trial to evaluate the safety and efficacy of Rho-associated protein kinase(ROCK) inhibitor Ripasudil eye drops for preterm infants with Retinopathy of Prematurity(ROP).

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