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
The aim of this study is to investigate the effect of baby massage applied to babies with retinopathy of prematurity on the pain and comfort of the newborn. This was randomised-controlled study in the NICU at the Health Sciences University Bursa High Specialization Training and Research Hospital, Bursa, Turkey. The population of the study will consist of preterms hospitalized in the neonatal intensive care unit during the time period of the study. In the calculation of the sample size, the power level was 80% and the significance level was 5%. When the effect size was determined as 0.8 in the examination of the difference between the experimental and control groups in terms of the premature infant pain profile (PIPP) variable, it was determined by the statistical expert that the number of babies to be included in each group was 26 and 52 babies in total should be included in the study. Based on this, the study sample was determined as 60 preterm infants in 30 experimental and 30 control groups. Block randomization method will be applied in the randomization of the groups. Case report form, PIPP=Premature Infant Pain Scale and Premature Infant Comfort Scale (PBIQ) will be used to collect the study data. Patients included in the study will be examined by the same ophthalmologist. The infant massage to be applied before the examination will be applied by a single nurse=researcher. Video recordings will be taken before and during the ROP examination and evaluations will be made by two neonatal nurses other than the researcher. Infants will be massaged by the researcher in accordance with IAIM guidelines and massage techniques. Total massage time will be equal for each infant. The researcher has an IAIM infant massage certificate. Before starting the infant massage, jewelry will be removed and hands will be washed. In the study, leg and face massage will be applied among the massage techniques in the IAIM guidelines.
This is an observational study in which only data from babies with retinopathy of prematurity (ROP) who are being treated with aflibercept (Eylea) in prefilled syringe (PFS) using a paediatric dosing device (PDD) are collected and studied. ROP is a condition that affects the eyes of preterm babies. It occurs when the baby's retina, the part of the eye that senses light, does not develop normally. This may result in vision problems, including blindness, if left untreated. Preterm babies are born before 37 weeks of pregnancy. ROP is more likely to develop in babies who are born before 32 weeks of pregnancy or weigh less than 1.5 kilograms at birth. Aflibercept is a drug that is injected into the eye. It works by blocking a protein called vascular endothelial growth factor (VEGF) which causes abnormal growth of blood vessels in the retina. Aflibercept in PFS given using a PDD is approved for the treatment of babies with ROP. The prefilled syringe will be fitted with an injection needle to give aflibercept. And a PDD is a tool used to give the right amount of aflibercept to children in a safe manner. Since there are other treatments which are commonly used for babies with ROP, the extent of use of aflibercept given using a PDD is unknown. The main purpose of this study is to: - find the number of preterm babies who are treated with aflibercept using a PDD in the UK - inform whether this number is enough to perform a study to learn about the long-term safety of aflibercept given using a PDD in babies with ROP An additional purpose of this study is to describe characteristics including age, sex, and race, and signs and symptoms of ROP observed in babies being treated with aflibercept using a PDD. The data will come from a database called the National Neonatal Research Database. The study will cover the period from March 2024 to March 2025, if the number of babies found is enough to perform the safety study. If not, data will be collected till April 2027. In this study only available data from preterm babies born during the study period are collected. No visits or tests are required as part of this study.
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.
The study includes preterm infants who are being screened for ROP between August 1,2023 and August 1, 2024 in 94 neonatal intensive care units (NICUs) in Turkey. Infants with birth weight (BW) of >1500 g or ≥ 33 weeks' gestation who are screened for retinopathy of prematurity are included. The incidence of any ROP, severe ROP and treatment modalities will be determined. The risk factors for ROP development will also be evaluated.
In this study, the investigators aim to improve image acquisition and preprocessing pipeline for FDA application. Our previous research has used various methodologies to identify images to input into the algorithm. The investigators aim to evaluate the effect of image quality and field of view on the output of the device in addition to performing a precision study to evaluate the effect of different camera operators on image selection and device output. Additionally the investigators aim to assist conducting pivotal clinical study for assistive diagnosis. Based on two previous meetings with the FDA, the clinical study will test the following hypothesis: use of the i-ROP DL VSS improves the accuracy of plus disease diagnosis among clinicians performing telemedical review of images. The investigators also aim to assist in conducting pivotal clinical study of autonomous ROP screening. Preliminary data suggests that the i-ROP DL system could achieve 100% sensitivity for detection of severe ROP. The investigators will perform a clinical study to support a revised indication for use as an autonomous AI screening device. Output of the i-ROP DL system will be compared to masked telemedicine grading for identification of referral-warranted and treatment-requiring ROP.
Background: Preterm infants undergo serial eye examinations during their hospital stay to monitor for the development of a specific disease termed "retinopathy of prematurity". While those examinations are known to cause significant pain and stress, the current standard of care (sucrose and local anesthesia) is not adequate in terms of alleviation of pain. Purpose: The goal of this clinical trial is to test the effectiveness of dexmedetomidine for pain management in preterm infants undergoing routine eye examinations. The main questions it aims to answer are: - Does dexmedetomidine reduce the pain scores of preterm infants during and shortly after eye assessments in comparison to placebo (saline 0.9%). - Does dexmedetomidine cause more adverse effects than placebo. In this crossover study participants will receive either dexmedetomidine or saline 0.9% intranasally 30 minutes before the examination, on top of the current standard of care. The participants will be monitored closely for 5 hours to note differences in adverse effects. The researchers will use video monitoring to assess the pain scores using a standardized and validated scoring system.
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.
Retinopathy of prematurity (ROP) is a widely known retinal vascular disorder in preterm infants and a leading cause of visual disability or blindness in children. Advances in antenatal care have resulted in an increase in the survival rate of infants with extremely low birth weight (BW). Approximately 90% of infants who develop ROP do so by a postmenstrual age of 46.3 weeks. In certain patients with or without treatment, the retina may fail to fully vascularize or may develop vascular abnormalities, thus demonstrating persistent avascular retina (PAR) or anomalous vessel findings at the periphery. Because of the advent of technologies such as ultrawide-field fluorescein angiography (UWFFA) persistent vascular abnormalities can be detected more readily and investigated.