View clinical trials related to Myopia.
Filter by:The purpose of this Post-Market Clinical Follow-Up (PMCF) study is to assess long term performance and safety of Air Optix® Night and Day® Aqua (AONDA) contact lenses in a real-world setting when worn as daily wear for vision correction.
The intended purpose of the investigational device in the study is the correction of myopia and myopia with astigmatism in the CE (Conformité Européene) approved range and optimized for presbyopic patients using the treatment option HiSMILE, installed on the VisuMax femtosecond laser.
to analyze the changes in corneal biomechanics of myopic children with different treatment (low concentration atropine eye drops and orthokeratology) and explore the possible mechanism of myopia control
Assess the Safety, Pharmacodynamics, and Efficacy of EXP039 Ophthalmic Solution in Participants with Myopia or Hyperopia
Successful treatment of residual refraction 6 months after IOL Implantation with Relex-Smile.
The aim of this study is to assess visual and refractive outcomes after laser vision correction (LVC) - ReLex Smile to correct residual myopic refraction after 6 months of pseudophakic (IOL) implantation. Before SMILE YAG-Laser capsulotomy should be performed on all patients, regardless of posterior capsule ossification, in pseudophakic patients with residual refraction. When the YAG Laser is applied after the SMILE, there will be a diopter change.
Investigators are going to conduct a randomized controlled trial that myopic children are randomly allocated into two groups: combined use of 1% atropine and 0.01% atropine (experimental group) and 0.01% atropine (control group) in order to explore a better way to control myopia progression and eliminate adverse effects at the same time, provide reliably evidence for clinical guideline of atropine use in children, and investigate the mechanism of atropine on eyes.
Age-related macular degeneration (AMD) is the leading cause of irreversible vision loss in developed countries among people over 50 years of age. Myopic maculopathy is also an important cause of irreversible vision loss. Reduced near visual acuity is still a major problem with all forms of AMD and myopic maculopathy. Various intraocular lenses for near vision (IOLs) or telescopic systems have been described but are not widely accepted and almost all solutions require phakic status of the eye and are implanted during cataract surgery. Therefore, these devices are not appropriated for pseudophakic AMD and myopic maculopathy patients. Scharioth Macula Lens (SML, Medicontur) is a magnifying intraocular lens for pseudophakic patients implanted in the ciliary sulcus in one eye of each patient. The implant has a bifocal optic, with a central 1.5mm diameter optical zone equivalent to +10D add and a peripheral zone optically neutral. The implantation of the add-on SML can improve the near visual acuity of pseudophakic patients with AMD and myopic maculopathy without impairing their distance visual acuity. The principal objective is to compare the near visual acuity, the far visual acuity and the self-reported vision health status before and after the SML implantation.
1.1 Research objectives A．To observe the fundus changes in the posterior pole (morphology, thickness, asymmetry, blood flow density, etc) with the myopia progression. B．To observe morphological changes in choroid and peripheral region of retina with myopia progression. C. To observe changes of visual function (contrast sensitivity, Microperimetry, etc) with myopia progression. D. To detect the susceptibility genes related to high myopia and myopic fundus changes; to test the levels of Vitamin D, riboflavin, transforming growth factor（TGF）, insulin-like growth factor（IGF）, fibroblast growth factor（FGF）, etc. E. To observe the changes of living quality, psychology, behavior and social activities of high myopic children. 1.2 Research design Prospective cohort study. After completing the baseline survey, the planned follow-up frequency is once a year. 1.3 Research cycle 2018.06~2038.06 (at least). 1.4 Expected results A． Registration completed a study of high myopia research for children and adolescents covering around 3,000 people; B． Establish a database information management system and workflow SOP（standard operating procedure）file for the study of high myopia registration in children and adolescents; C． Further clarify the changes in the retinal, choroidal and scleral tissue structures, blood flow density, etc. in the macular area and the optic disc; D． Revealing the changes of the retina, choroid and other tissues in the peripheral area with the progression of myopia; E． To clarify the relationship between changes in the fundus structure and changes in visual function in the posterior pole; F． Further clarify the etiology and pathogenesis of high myopia, pathological myopia and myopic fundus lesions, and identify the relationship between high myopia and pathological myopia; G． From the perspectives of society, behavior and psychology, the effects of high myopia and pathological myopia on children and adolescents will be fully demonstrated. 2. Research object 2.1 General characteristics of the research object Based on the refraction development archive system that has been constructed in Shanghai, the list of children and adolescents with high myopia was selected from the database of children's refractive development archives information in Shanghai. Children of different ages with high myopia must meet the following conditions: 1. 4-5 years old, equivalent spherical error(SE) ≤ -4.0 diopter(D）; 2. 6-8 years old, equivalent spherical error(SE) ≤ -6.0 diopter(D）; 3. 9-18 years old, equivalent spherical error(SE) ≤ -8.0 diopter(D）. 2.2 Sample size A total of 1.25 million children and adolescents are currently registered, 4,006 (0.32%) of which meet the entry requirements. Among the 4~5 year olds, there are 815 people with SE≤-4D; 842 people with SE≤-6 D among the 6~8 year olds; 2349 people with SE≤-8D among the people aged 9 and over . Taking into account the 50% non-response and the proportion of the exclusion, the initial registration number is about 2,000. 2.3 Source of study object Children and adolescents who meet the inclusion criteria in the Shanghai Children's Refractive Development Archives Information Database System.
Control of myopia progression has become an important goal because of concerns regarding significantly increased risks of retinal degeneration, retinal detachment, glaucoma and cataract associated with high myopia. It is also clear there prevalence of myopia in children and young adults is increasing all over the world. Several methods including use of progressive addition lenses, rigid gas-permeable contact lenses, and life-style modifications (increased outdoor activity) have reported to alter myopia progression with varying efficacy. In general they have yielded clinical results of marginal significance. Atropine sulphate eye drops has consistently been demonstrated to inhibit axial myopia progression in both humans and animal models. Yet it has not found widespread clinical application for myopia control due to ocular side-effects of cycloplegia and pupil dilation. Recently 0.01% atropine has been shown to be effective in arresting myopia progression without side-effects of cycloplegia and near vision impairment and pupil dilatation and increased light sensitivity. Almost all studies on atropine have been carried out on children of Chinese origin. Efficacy (concentration and dosing) and safety need to be established in the population of interest, before routine use can be recommended. We plan to evaluate the efficacy and safety of topical 0.01% atropine eye drops in slowing the progression of myopia and ocular axial elongation in Omani children. A total of 150 children of ages 6-16 years will be randomized to two groups. Intervention group will receive atropine 0.01% once daily in each eye for two years (Phase 1). Control group will not receive any medications. Follow up visits will be scheduled every three months in Phase 1. Subsequently, medication will be stopped and the study patients will be followed up every six months for one year (Phase 2). The progression of myopia (change in refractive error and axial length) will be compared in the two groups by objective methods.