View clinical trials related to Retinopathy of Prematurity.
Filter by:Aims: To evaluate the effects of topical Benoxinate HCL eye drops on the Premature Infant Pain Profile (PIPP) scores in infants undergoing Retinopathy of Prematurity (ROP) screening. Methods: A randomized prospective double-masked cross-over trial was conducted on preterm infants screened for ROP at least twice. Dilated fundus examination was done in Group A infants using the tear substitute eye drops and the second using the Benoxinate HCL drops and the reversed order of drops for Group B. Video recording of the pulse oximeter monitor, the face and the body of the infant were analyzed by a single neonatology consultant for Premature Infant Pain Profile (PIPP) scoring 1 minute before, during the examination of the first eye, 1 minute and 5 minutes after the conclusion of the examination of the second eye. The sound of the ophthalmologist on the video recordings indicating the time of the lid speculum insertion, the shining of the indirect ophthalmoscope light without indentation and the scleral indentation would aid in assessing the differences of the PIPP indicators during each step of the examination.
Ophthalmological differences in school-aged children with and without a history of retinopathy of prematurity
A prospective, randomized controlled study was conducted from August, 2022 to March, 2023 in the neonatal intensive care unit in Queen Mary Hospital, Hong Kong. The aim of this study was to determine whether microdrops Mydrin-P demonstrates similar efficacy as standard Mydrin -P eyedrops applied to neonates undergoing retinopathy of prematurity (ROP) screening exams, also to ascertain the optimal time for eye examination after administration of mydriatics and assess whether the cardiovascular, respiratory and gastrointestinal adverse effects differ between microdrops and standard dose Mydrin-P. Preterm infants were randomized to receive either the standard Mydrin-P eyedrops or the mydriatic microdrops which contained around one-third of the standard Mydrin-P dosage. The primary outcome measured whether a successful ROP examination was conducted. Secondary outcomes included pupil diameters at baselines, 30 minutes, 60 minutes, 120 minutes after eyedrops instillation and at the time of ROP exam as well as adverse effects followed by the mydriatics administration. A total of 18 patients were enrolled in this study with total 46 episodes of ROP recorded. All episodes with microdrops instillation led to successful ROP exams. There was no statistically significant difference between standard eyedrops and microdrops in determining the success of ROP exam (p=0.233). Mean pupil diameter did not differ between the microdrops and standard eyedrops group. At the time of ROP exam, the mean pupil diameter was 5.47mm in the standard eyedrops group and 5.73mm in the microdrops group. The optimal time for ROP exam was 60 minutes to 120 minutes after first dose of mydriatic. Also there was no difference in the occurrence of systemic side effects when compared to standard Mydrin P drops. Hence the study concluded that microdrops have similar efficacy and safety profile compared to standard Mydrin-P eyedrops.
Retinopathy of prematurity (ROP) is a preventable cause of blindness in babies who are born early i.e. premature. Internationally, there is a shortage of skilled ophthalmologists willing and able to screen for ROP. Even in the UK, not all hospitals have skilled ophthalmologists and premature babies have to travel to other hospitals, often long distances, to have their eyes examined. As a missed examination can lead to sight loss, this is a burden for families and carers of premature babies. To fill this gap, previous studies have explored the use of non-ophthalmologists healthcare workers to increase the workforce screening for ROP. Recently, the Optos ultra-widefield retinal-imaging device (Optos PLC, Dunfermline, Scotland, UK) has been used to help document different stages of ROP in infants. This specialised retinal imaging system uses an internal ellipsoid mirror to capture fundal imaging angles of up to 200 degrees, or more than 80% of the entire retina, in a single image. A single retinal image can be acquired in a quarter of a second and is automatically captured when the infant's pupils are aligned with the Optos imaging device. No contact with the eye is necessary to capture an image of the retina. To date, there are no studies that have validated the Optos as a nurse-led screening tool for ROP. This is a prospective study to determine and validate the feasibility of neonatal nurse-led retinal imagers for ROP screening employing the Optos imaging device. The main purpose of this study will be to test if it is possible for trained nurses to take good images of the back of babies eyes (retina) and if these images can be used by remotely placed ophthalmologists to diagnose and grade ROP. The investigators will compare how good the diagnosis and grading done using Optos images are compared to the current gold standard method (BIO). The investigators will also test how much agreement there is between ophthalmologists in interpreting Optos images by asking two ophthalmologists to grade the images.
This study aimed to compare the effectiveness of two interventions, white noise, and multisensory stimulation, during retinopathy examinations on premature infants. Retinopathy is a common eye disorder among premature infants, which can cause visual impairments if not addressed. The research used a randomized controlled experimental design, with premature infants randomly assigned to either the white noise or multisensory stimulation group or control group. Physiological responses, behavioral indicators, and the pain of the retinopathy examination were measured. Trained healthcare professionals conducted the investigations in a controlled environment, and statistical analyses were employed to compare the outcomes between the three groups. The findings of this study have the potential to inform the development of more effective and well-tolerated examination protocols for premature infants, leading to improved visual outcomes and overall well-being for this vulnerable population.
Retinopathy of prematurity (ROP) is a retinal disorder of preterm neonates and a potential cause of blindness. As early diagnosis and treatment preserve vision, very low birth weight infants must be screened for ROP. Mydriatic eye drop administration is essential to perform funduscopic evaluations. The most commonly used mydriatic drops for pupil dilatation are 0.5-1.0% tropicamide and/or 0.5-1.0% phenylephrine or 0.2-1.0% cyclopentolate. Phenylephrine, an alpha-1 sympathomimetic agonist, is readily absorbed from conjunctival mucosa and has a potent systemic vasopressor effect. Tropicamide causes cycloplegia by inhibition of ciliary muscle contraction and has a short acting para-sympatholytic effect. Systemic absorption of mydriatic eye drops has been associated with cardiovascular, respiratory and gastrointestinal adverse effects. Systemic side effects include apnea, desaturation, increased heart rate and blood pressure, delayed gastric emptying, and feeding intolerance. The data about the effects of mydriatics on cerebral blood flow and tissue oxygenation are sparse. Cerebral blood flow autoregulation depends in part on the adrenergic and cholinergic control of cerebral vasculature, but whether mydriatics have an effect on cerebral haemodynamics is unknown. Near-infrared spectroscopy and Doppler ultrasonography (US) are non-invasive methods commonly used for neuromonitorization in NICUs. The regional blood flow changes measured using Doppler US have been reported to be associated with cerebral oxygenation and indicate a high correlation with NIRS in newborns. The aim of this study was to evaluate the effects of mydriatic eye drops on cerebral oxygenation and blood flow in preterm infants by NIRS and Doppler US.
This study aimed to evaluate the effects of multisensory stimulation on pain and physiological parameters resulting from ROP examination in preterm newborns. It was planned as a randomized controlled trial. trying to reach 80 newborns in total. Multisensory stimulation will be applied to the intervention group during the examination. In the control group, routine care will be applied during the examination.
The analysis of saliva of preterm newborns could be a powerful tool to investigate human fetal development in an ethically acceptable fashion, indeed the collection of salivary samples is a fast and non-invasive procedure. The purpose of the study is to characterize peptide and proteins present in human preterm saliva and to investigate the relative amount of several proteoforms of the proteins and peptides detectable in preterm saliva in order to have information on the activity of various enzymes acting during late fetal development. Preterm infants with gestational age between 175-216 days (25-30 weeks), admitted to the Neonatal Intensive Care Unit (NICU) will be enrolled for this study. A saliva sample will be collected every seven days from the birthday and up to 40 weeks (286 days) of postmenstrual age (PMA) or up to discharge if it occurs earlier. A targeted ESI mass spectrometry investigation, based on a top-down analysis of the intact salivary proteome will be performed.
The aim of our study was to determine whether a low dose of 0.3125mg intravitreal bevacizumab is effective in treatment of type 1 ROP as the standard 0.625 mg dose., regarding : Serum Systemic VEGF levels. Retinal Vascularization.
Despite advances in the neonatal intensive care units, retinopathy of prematurity (ROP) has become a common reason for blindness and visual disabilities in premature infants so that it accounts for about 5% and 30% of such complications in developed and developing countries. The pathophysiology of ROP is multifactorial. Supplemental oxygen demand and lower gestational age (GA) and birth weight (BW) are among the major risk factors for the occurrence and progression of ROP. Anti-vascular endothelial growth factor (anti-VEGF) agents are a promising modality of treatment for ROP, as laser therapy is associated with disadvantages such as complications from undertreatment or overtreatment, anterior segment burns, hemorrhage, or ischemia, and potentially higher rates of myopia. Ranibizumab is the first approved anti-VEGF treatment for the management of retinopathy, and is a promising alternative to laser therapy. Ranibizumab is a humanized monoclonal recombinant antibody fragment with a shorter half-life and less systemic toxicity than bevacizumab. Its binding affinity is nearly tenfold that of bevacizumab. The plasma half-life of bevacizumab is 17-21 days, while that of ranibizumab is 3 days. Greater systemic absorption of bevacizumab is thought to lead to greater systemic suppression of VEGF. These data may explain the better safety profile of ranibizumab. Type I ROP is defined as any stage of ROP with plus disease in zone I, stage 3 ROP in zone I and stage 2 or 3 ROP with plus disease in zone II . The hallmark of Aggressive-ROP (previously known as Aggressive posterior-ROP) is rapid development of pathological neovascularization and severe plus disease without progression being observed through the typical stages of ROP. It may occur in larger preterm infants and beyond the posterior retina. The aim of this prospective study is to compare the efficacy of intravitreal ranibizumab for type 1 ROP and A-ROP as regard acute ROP regression, recurrence profile, peripheral retinal vascularization and the need for further ablative therapy.