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NCT07653074
Society has become increasingly digital, and many everyday services have been replaced by digital self-service solutions. This puts greater demands on our vision and our ability to interpret what we see. At the same time, the number of children with nearsightedness (myopia) has increased rapidly. In some parts of Asia, as many as 60-70% of students in seventh grade are nearsighted (1), and a similar trend may develop in Europe. Nearsightedness is becoming a growing challenge in pediatric eye care. High myopia can lead to complications that require early detection and prevention. There are now several ways to slow down its progression, such as special contact lenses, glasses, and eye drops (2). However, the scientific evidence for these treatments varies, and there are currently no national or Nordic guidelines on how to use them. In addition, myopia may have a major impact on children's quality of life. Currently, there is no validated Swedish questionnaire that measures vision related quality of life across all age groups in children and adolescents. To address this, researchers in the United States developed the Pediatric Eye Questionnaire (PedEyeQ) in 2019 (3). It is already available in English and Spanish and takes into account both the child's and the parent's perspectives on vision and daily life. The aim of this study is to translate, culturally adapt and test the PedEyeQ in Swedish children and adolescents, and to investigate how common refractive errors, especially nearsightedness - are today compared to 20-30 years ago. The study will include 300 healthy children and adolescents aged 0-17 years, divided into three age groups: 0-4 years, 5-11 years, and 12-17 years. Participants will be recruited through child health centers, preschools, and schools in the Örebro region. All participants will visit the eye clinic for a detailed eye examination, including: * Testing distance and near visual acuity * Measuring eye refraction (with and without eye drops that temporarily relax the eye's focusing muscles) * Imaging the retina using Optical Coherence Tomography (OCT) * Measuring eye length and corneal shape * Checking eye pressure and contrast sensitivity Children and parents will also answer questions about how the child's vision affects everyday life and wellbeing. For the youngest children (0-4 years), only parents will answer the questions. The PedEyeQ will be translated into Swedish following the International Society for Pharmacoeconomics and Outcome Research (ISPOR) (4) guidelines to make sure it is culturally relevant and easy to understand. The Swedish version will then be tested to ensure it is accurate and reliable. All information collected in the study will be stored securely and anonymously. The results will also be compared with data from a similar cohort conducted in the 1990s to see if vision problems have become more common over time (5). This project will provide new knowledge about children's vision and quality of life in Sweden. A validated Swedish version of the PedEyeQ can be used both in healthcare and research to better understand how vision affects children's daily lives. The study will also offer updated information on the frequency of refractive errors among Swedish children and adolescents - knowledge that is essential for developing preventive strategies and improving eye care for the future.
NCT06616506
This study aims to establish a multi-center artificial intelligence model for the accurate calculation of intraocular lens and its clinical application in highly myopic cataract, so as to improve the accuracy of the prediction of postoperative diopter in highly myopic cataract patients.
NCT04700111
The objective of the study is to measure the difference in the lag of accommodation between DOT spectacle lenses and control spectacles.
NCT07462897
The goal of this clinical investigation is to learn how much a new generation of myopia control lens (MCL1 - Myopia Control Lens 1) is helpful in reducing myopia progression in children from 6 to 14 yo. The main questions it aims to answer is: How much this new generation of lens, called MCL1, slows down the growth of the eye? Researchers will compare MCL1 to a former generation of myopia control lens (i.e. MCL2) but with better vision quality. Participants will: * Wear MCL1 on right eye and MCL2 on left eye for 6 months and MCL2 on rigth eye and MCL1 on left eye for the next 6 months; * Visit the hospital at 6 and 12 months for tests; * Answer weekly questionnaires on compliance wearing glasses, quality of vision and out-of-school activities.
NCT07547072
The goal of this study is to investigate the short-term changes in choroidal thickness and efficacy of the study spectacle lenses in children. Participants will be prescribed with a pair of study spectacle lenses for daily use and visit the clinic once every week for the first month for checkup and tests. After the first month of follow-up, participants will visit at 1 month, 6- and 12-month for checkup. Choroidal thickness, axial length and refractive errors will be monitored.
NCT07544615
Significance, Background, and Current Status Studies show the global average prevalence of myopia is 22%, with hyperopia incidence being similar. In China, the myopia prevalence is 31%, making it one of the countries with the highest rates of myopia. Currently, the safety and efficacy of corneal refractive surgery (CRS), such as LASIK and SMILE, for correcting myopia, hyperopia, and other refractive errors are well-established. An increasing number of patients undergo CRS to alleviate the inconveniences caused by refractive errors. While LASIK has long been regarded as a classic procedure, since the first report of Small Incision Lenticule Extraction (SMILE) for myopia correction in 2008, it has evolved into one of the mainstream surgical techniques. With the rapid advancement of refractive surgery, minimizing postoperative complications while maintaining excellent visual outcomes has become a major focus for clinicians. Postoperative intraocular pressure (IOP) monitoring is a crucial observation index. Theoretically, IOP should not change significantly after CRS, as the surgery does not affect aqueous humor dynamics or intraocular volume. However, numerous studies indicate that alterations in corneal shape and biomechanical properties, particularly corneal thinning, lead to artificially low IOP readings with various tonometers, especially those dependent on corneal thickness. Furthermore, postoperative management often requires prolonged use of corticosteroid eye drops to suppress inflammation and promote wound healing. Extended steroid use can increase aqueous outflow resistance, elevating IOP, particularly in steroid responders, and potentially leading to steroid-induced glaucoma. Additionally, high myopia is a known risk factor for primary open-angle glaucoma. Therefore, based on preoperative and postoperative corneal parameter changes, rapidly and effectively determining the actual IOP range after CRS is of great significance for guiding clinical medication and screening for steroid-induced glaucoma. Big Data and Artificial Intelligence (AI) are increasingly applied in medicine. AI primarily includes two technical branches: machine learning (ML) and deep learning. ML, a novel AI technology, has garnered significant interest in medical applications in recent years. It typically involves computer simulations that integrate human-like learning, refine knowledge structures, and continuously improve performance to aid diagnosis and intelligent decision-making, becoming a pivotal method in AI. Resembling neural network processes, ML systems are trained on selected input data using appropriate algorithms to produce corresponding outputs. It is now widely used to solve complex problems in engineering and science. In ophthalmology, AI/ML has gained attention for assisting in disease detection and monitoring, demonstrating advantages in fundus image diagnosis, keratoconus screening, and glaucoma classification. In corneal refractive surgery, ML has been applied to preoperative parameter design and outcome optimization, showing good safety, efficacy, and predictability. Preliminary attempts have been made to use AI decision trees to evaluate the safety and efficacy of CRS. Building on this advanced technology and our previous research findings-which suggest that IOPcc and Pentacam-derived correction formulas (with the Shah correction method being preferable) provide relatively reliable IOP estimates after SMILE-this study aims to establish a data-driven model. Using Shah-corrected IOP as a reference to define postoperative IOP status, we will train and iteratively optimize a model by incorporating all relevant preoperative and postoperative parameters potentially affecting IOP. The goal is to predict the true IOP after CRS, thereby guiding postoperative follow-up, facilitating early detection of IOP elevation, and identifying potential glaucomatous tendencies.
NCT07535749
The study will employ a randomized, controlled, investigator-masked paired-eye comparison design to evaluate the effects of two myopia-control contact lenses-MiSight 1 Day and Abiliti 1-Day-in New Zealand Chinese children. The study duration will be 6 months, with assessments conducted at baseline, 2 weeks, 3 months, and 6 months. The clinical research will be conducted at the Auckland Myopia Clinic (New Zealand) and will follow a standard clinical routine for children with early myopia, the only difference being the randomizing of the MiSight and Abiliti contact lenses between the two eyes of the participants.
NCT06817785
The aim of this study is to evaluate and compare the performance of two soft contact lenses.
NCT07104773
The aim of this study is to evaluate and compare the performance of two soft contact lenses.
NCT07505264
Small incision lenticule extraction (SMILE) procedure is a well-known procedure for the correction of myopia. The purpose of this research study is to compare the two SMILE procedures with different laser platforms (VISUMAX 500 and VISUMAX 800) used for the correction of short-sightedness. The VISUMAX 800 and VISUMAX 500 perform the same procedure, but the VISUMAX 800 is a newer platform. This study is being done to see if the newer VISUMAX 800 provides the same or better results than the VISUMAX 500.
NCT07497672
The primary objective of this study is to evaluate the visual acuity, wearability, and quality of vision with two novel multifocal glasses designs in habitual myopia control glasses wearers, in a non-dispensing study after short-term wear.
NCT06949579
In this cross-sectionnal study the aim is to increase the understanding of posterior staphyloma through a unique European consortium. Therefore, all eligible patients that either visit the outpatient clinic at Radboud in Nimegen, the Netherlands, or visit University Hopital Puerta de HierroMajadahonda in Madrid, Spain, or visit University Hospital Cochin in Paris, France, and after consenting, will be included. 600 high myopic European cases are expecting. A standardized protocol in all centers in order to create a uniform dataset. Besides the standard of care, blood samples will be collected. All data collected will be stored in an onlie Castor database
NCT06668909
This study is a multi-site, single-arm, ambispective, observational study of subject satisfaction, after successful bilateral LASIK surgery. Subjects will be assessed 12+ months post-operatively. Clinical evaluations will include administration of the OSDI, modified PROWL, and dry eye questionnaires.
NCT06278974
The research project titled "A Comparative Study on the Clinical Efficacy, Quality of Life, and Cost of Use of Peripheral Defocus Spectacles, Frame Glasses, and Orthokeratology Lenses in Myopic Children and Adolescents" aims to evaluate different non-surgical myopia correction methods in children. It focuses on assessing the impact of peripheral defocus spectacles, frame glasses, and orthokeratology lenses on the quality of life, clinical effectiveness, and costs associated with each method. The study is a prospective cohort study involving 90 children aged 8-17 years with myopia ranging from -1.00D to -6.00D. It aims to compare the psychological, social, and educational aspects of these correction methods, alongside their costs and clinical outcomes over a period of one year.
NCT05850936
Currently, whether and when intraocular pressure (IOP) lowering medication should be used in progressive high myopia (HM) to control axial elongation is still a dilemma. Randomized trials are required to evaluate whether IOP lowering influences the growth of axial length in progressive HM eyes.
NCT04283149
This objective of this study is to evaluate the safety, and to collect supportive data on effectiveness of the EVO/EVO+ Visian® Implantable Collamer® Lens (ICL) in study participants who have a diagnosis of myopia or myopia with astigmatism. Primary study analysis will be evaluated when 300 primary eyes complete 6 months of follow-up. Final study analysis will be assessed when all treated eyes complete 36 months of follow-up.
NCT07473401
The aim of the present study is to gain more information about retinal functional parameters in myopic children in Europe. For this purpose, a prospective case-control study in children aged between 8 and 13 years, as this is the usual age of myopia onset, will be conducted. Forty myopic children will be age- and sex-matched to non-myopic controls. Retinal oxygen extraction will be used as the main outcome parameter, as data from animal and human studies point towards an involvement of hypoxia in the disease process. In addition, other parameters probably linked to myopia will be investigated, such as retinal and choroidal blood flow as well as choroidal and retinal vessel density and anatomical structures such as choroidal and central retinal thickness. Also, questionnaires about lifestyle factors will be completed.
NCT03152747
Phacoemulsification with implantation of posterior chamber lenses represents the gold standard of care for patients needing lens surgery, but there is an increased risk of developing pseudophakic retinal detachment after surgery. Especially myopic patients have an even higher risk of pseudophakic retinal detachment compared to the general population. The aim of this multicenter study is to document the presence and/or post-operative development of posterior vitreous detachment (PVD) and to assess its influence on the incidence of retinal detachment (RD) in myopes in a time period of three and five years after lens surgery. 618 eyes of patients scheduled for regular lens surgery will be included, defined by an axial length of 25.0 mm or more. To examine the vitreous status, all patients will receive a comprehensive eye examination pre-operatively, including funduscopy with assessment of a Weiss ring and optical coherence tomography (OCT). Patients will be divided into two groups, group A with pre-operative complete PVD and group B with no/partial PVD. Group A will be invited for one follow-up visit (two months post-operatively) followed up by telephone interviews at one, two, three and five years after surgery to determine occurrence of pseudophakic retinal detachment. Group B will be invited for follow-up examinations at two months, six months and one year after surgery to document occurrence of PVD (if a PVD is present at one of the follow-ups, no more visits are necessary). Two, three and five years after surgery, all patients from group B will be interviewed by telephone, as in group A, to document the occurrence of pseudophakic retinal detachment. In the recent literature the association between the occurrence of PVD pre-/post-operative and RD after lens surgery is well documented but not described for myopic patients. The results of this multicenter study should help to tackle the problem of RD prediction in myopic patients depending on their pre-operative vitreous status, especially in the setting of refractive lens exchange.
NCT05740930
Myopia is considered to be the most common type of refractive error, and the incidence of myopia has shown a trend of low age. Recent studies found that the new aspheric microlens spectacle lens can more effectively control the progress of diopter than the single-vision spectcale lens. A new technology of equivalent defocusing around the lens called the partition multi-point defocus optical technology is adopted in this study.
NCT04699357
Objective: to evaluate the efficacy of different concentrations of atropine eye drops in controlling the progression (diopter, axial length) of high myopia in young children, and to compare the compliance, adverse reaction and regression rate of different concentrations of atropine eye drops in myopia control. Intervention: Group 1 (0.01% atropine group), Group 2 (0.04% atropine group), Group 3 (0.1% atropine group). During the 2-year intervention period after entering the group, each concentration of atropine eye drops were given every night at a fixed time before going to bed, one drop each time, implemented by parents (supervision), and the wechat small program was completed.