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Retinopathy of Prematurity clinical trials

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NCT ID: NCT00623220 Completed - Clinical trials for Retinopathy of Prematurity

Inhaled Nitrous Oxide for Pain Relief During Eye Exam in the Pre-term Infant

Start date: March 2008
Phase: Phase 3
Study type: Interventional

The primary objective of the proposed study is to show that inhaled equimolar mixture of oxygen and nitrous oxide (EMONO) will reduce pain associated with retinal exam in the preterm infant, as compared to the current standard treatment (oral sucrose and topical anaesthesia). The investigators also aim to show that EMONO can be used safely in preterm neonates undergoing retinal exam, and will not result in any increase in apnea, bradycardia, or desaturation in the 24 hours following the exam. Finally, the investigators aim to show that EMONO will keep the infant calm, and make retinal examination easier and less traumatic.

NCT ID: NCT00622726 Active, not recruiting - Clinical trials for Retinopathy of Prematurity

Bevacizumab Eliminates the Angiogenic Threat for Retinopathy of Prematurity

BEAT-ROP
Start date: March 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study was to determine the efficacy and additional advantages of intravitreal bevacizumab in the treatment of ROP for both Zone I and Zone II Posterior.

NCT ID: NCT00563121 Withdrawn - Clinical trials for Retinopathy of Prematurity

VEGF Levels in Aqueous, Vitreous and Subretinal Fluid in ROP Stage IV and V

Start date: March 2007
Phase: Phase 4
Study type: Interventional

To determine the degree of VEGF in Aqueous, vitreous and SRF in patients with ROP in stage V. Verifying that it is greater to that found in healthy newborn patients with different ocular pathology.

NCT ID: NCT00500396 Terminated - Clinical trials for Retinopathy of Prematurity

Vascular Endothelial Growth Factor in Stage V ROP

Start date: March 2007
Phase: Phase 4
Study type: Interventional

Vascular Endothelial Growth Factor (VEGF) is a dimeric glycoprotein, naturally expressed in epithelial and tumor cells (1). Normal Retinal vascularization has two phases: In the first fase, cells of mesenquimatous origin form the first superficial plexus (14-21 weeks of gestation). In the second phase, denominated "angiogenesis phase", the superficial and deep capillary plexus are formed (15,20). The Retinopathy of Prematurity (ROP) was described for the first time in 1942 (4), at the present moment it is a public health problem in the developing countries. The International Classification of ROP classifies it in 5 stages, dividing it in 3 anatomical zones. It is a public health problem that continuous without having an effective prophylaxis. The early diagnosis and treatment in thresholds stages have changed the prognosis of this disease (11,12).

NCT ID: NCT00427063 Completed - Clinical trials for Retinopathy of Prematurity

Heredity of Retinal Vessel Tortuosity

Start date: January 1998
Phase: N/A
Study type: Observational

The purpose of this study is to asses the relative influence of genetic and environmental influence on the tortuosity of retinal arterioles in eyes of 218 healthy Danish twins aged 20-46 years. We expect to find a high heredity for the variation in tortuosity. This knowledge can contribute to the elucidation of the pathology in retinal diseases.

NCT ID: NCT00417404 Completed - Preterm Birth Clinical Trials

Vitamin A and Very Low Birthweight Babies (VitAL)

Start date: January 2007
Phase: Phase 4
Study type: Interventional

Vitamin A is important for the development of healthy eyes and lungs. Very low birth weight premature babies have low body stores of vitamin A and are prone to diseases of the eye and lungs. Previous work has shown that intramuscular (IM) vitamin A reduces the number of babies who require prolonged oxygen therapy, and may also reduce the number of babies affected by retinopathy of prematurity (ROP)). There is also some evidence that the conjunctiva shows signs of deficiency of vitamin A in premature infants, particularly those who develop ROP. Our own work here in Glasgow suggests that, compared to babies born at full term, premature babies' eyes are less sensitive to light and we believe that this may reflect shortage of vitamin A in the eye. This study will examine the effects upon the eye of giving extra intramuscular vitamin A to very low birth weight, premature infants. We will also measure blood levels of vitamin A and calculate liver stores of this nutrient.

NCT ID: NCT00349726 Completed - Clinical trials for Retinopathy of Prematurity

Single-Dose Intravenous Inositol Pharmacokinetics in Preterm Infants

INS-1
Start date: June 2006
Phase: Phase 2
Study type: Interventional

This pilot study was a randomized, placebo-controlled, clinical trial to measure changes in blood and urine levels of inositol in premature infants at high risk for retinopathy of prematurity (ROP) following a single intravenous dose of inositol. Based on previous studies, the premise is that maintaining inositol concentrations similar to those occurring naturally in utero will reduce the rates of ROP and bronchopulmonary dysplasia in premature infants. The objective was to evaluate the single-dose pharmacokinetics and safety of different amounts of intravenous myo-inositol (provided by Ross Products Division, Abbott Laboratories) in very low birth weight neonates, in preparation for a future Phase III multi-center randomized controlled trial. This study enrolled 74 infants at high risk for retinopathy at 9 NICHD Neonatal Research Network sites, and randomly assigned them to receive either 60mg/kg of 5% inositol, 120 mg/kg of 5% inositol, 60 mg/kg of 5% glucose (the placebo), or 120 mg/kg of 5% glucose.

NCT ID: NCT00346814 Recruiting - Clinical trials for Retinopathy of Prematurity

Antiangiogenic Therapy With Bevacizumab in Retinopathy of Prematurity. Structural Outcome

Start date: July 2006
Phase: Phase 2/Phase 3
Study type: Interventional

Purpose:Retinopathy of prematurity (ROP) continues tobe a major cause of blindness in children. Although ablation of the retina with laser or cryotherapy reduces the incidence of blindness by suppressing the neovascular phase of ROP the visual outcomes after treatment are often poor. Vascular endothelial growth factor(VEGF) has an important role in the pathogenesis of ROP and inhibition of VEGF expression in the neovascular phase might prevent destructive neovascularization in ROP. The aim of this study is to determine the safety and efficacy of intravitreal bevacizumab in the treatment of retinopathy of prematurity

NCT ID: NCT00339001 Recruiting - Clinical trials for Retinopathy of Prematurity

Erythropoietin and Early Iron Supplement and Retinopathy of Prematurity

Start date: April 2006
Phase: N/A
Study type: Observational

To evaluate the possibility that erythropoietin with early iron supplementation may induce retinopathy of prematurity or worsen this disease. In addition risk factors for the development of ROP will be checked.

NCT ID: NCT00279669 Completed - Clinical trials for Retinopathy of Prematurity

Ultrasound to Detect Evidence for Retinal Detachment in Retinopathy of Prematurity

Start date: December 2004
Phase:
Study type: Observational

Premature infants stand a risk of danger to the layer of the eye that creates sight that, if untreated, can cause severe vision problems, leading to blindness in some cases. This research study will use ultrasound to examine the eye for retinal changes of prematurity.