Clinical Research Directory

Efficacy of a Novel Myopia Defocus Spectacle Lens in School-Aged Children

This study aims to evaluate the short-term efficacy and safety of a novel, proprietary spectacle lens. Forty myopic participants, aged 6 to 15 years, will be prescribed with the study spectacles for a period of six months. All subjects will be required to attend five scheduled visits. Change in subfoveal choroidal thickness (SfChT), axial length and refraction will be determined.

A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control

To date, randomized trials of low-concentration atropine eyedrops and specially designed spectacle lenses to slow the progression of myopia are limited in number and results are inconsistent in non-Asian children. Although results of some recent randomized clinical trials outside the US are promising, additional studies in children are needed to test the safety and efficacy of low-concentration atropine and specially designed spectacle lenses as treatments to slow the progression of myopia during the peak years for eye growth. After a run-in phase to demonstrate adherence with nightly eyedrops (artificial tears) and spectacle correction, children 5 to \<12 years old with myopia of 0.75D to 6.00D cycloplegic spherical equivalent refractive error (SER) and at least 0.75D myopia in both principal meridians of each eye will be randomized in a 2x2 factorial design to treatment with 1) nightly 0.05% atropine or placebo eyedrops, and 2) spectacles with highly aspherical lenslet target (H.A.L.T.) MAX technology or single vision spectacles, and followed every six months for 24 months. Change in axial length over 24 months and change in SER over 24 months are the primary and secondary outcomes, respectively. All children will return for a visit at 30 months (after 6 months of no treatment other than single-vision spectacles alone between 24 and 30 months).

The Impact of 'A Miss Is as Good as a Mile': Is Compensation Necessary for Minimal Ocular Deviation in Myopic Laser Surgery?

The goal of this clinical trial is to evaluate the effect of intraoperative kappa-angle compensation on postoperative visual quality in patients undergoing small incision lenticule extraction (SMILE) using the VisuMax 800 platform. The study will enroll patients with myopia and a kappa-angle offset \< 0.2 mm. The main questions it aims to answer are: Does intraoperative kappa-angle compensation reduce postoperative higher-order aberrations after SMILE? Does kappa-angle compensation improve postoperative visual quality and refractive outcomes compared with no compensation? Researchers will compare SMILE with intraoperative kappa-angle compensation to SMILE without compensation to determine whether compensation leads to better optical quality and visual performance. Participants will: Undergo SMILE surgery with or without intraoperative kappa-angle compensation Complete scheduled postoperative examinations at 1 week, 1 month, 3 months, and 6 months after surgery Receive measurements of visual acuity, refraction, higher-order aberrations, contrast sensitivity, and safety outcomes

Comparison of Low- Versus High-Level Angle Kappa Compensation Strategies in SMILE Using the VisuMax 800: A Randomized Clinical Trial

The goal of this clinical trial is to compare two intraoperative kappa-angle compensation strategies during small incision lenticule extraction (SMILE) using the VisuMax 800 platform in patients with relatively large kappa-angle offsets. Angle kappa represents the difference between the visual axis and the pupil center. In patients with a large offset, pupil-centered treatment may lead to decentration of the optical zone, which can induce higher-order aberrations and affect postoperative visual quality. The VisuMax 800 system allows intraoperative adjustment of the treatment center based on the measured offset, making different compensation strategies possible. The main questions this study aims to answer are: Does low kappa-angle compensation (50%) result in lower postoperative higher-order aberrations than high compensation (100%)? Does the compensation strategy influence visual acuity, refractive outcomes, contrast sensitivity, and subjective visual quality after SMILE? Are the measurements obtained from different diagnostic devices consistent when evaluating kappa-related parameters? Researchers will compare SMILE with low compensation to SMILE with high compensation to determine which strategy provides better optical quality and visual performance. Participants will: Undergo SMILE surgery using either low or high kappa-angle compensation Complete scheduled postoperative examinations at 1 month, 3 months, and 6 months Receive measurements of visual acuity, refraction, higher-order aberrations, contrast sensitivity, and patient-reported visual outcomes Be monitored for safety outcomes and adverse events during follow-up

Visual and Postural Behavior in Myopic and Non-Myopic Teenagers

The goal of this observational study is to learn whether different types of eyeglasses prescription and different types of lenses change how close teenagers hold objects when looking at them up close. The study includes adolescents who are non-myopic and adolescents who are myopic and wear either single-vision lenses or lenses slowing down myopia progression. The main questions it aims to answer are: Do teenagers in these three groups use different average working distances (eye-to-object distance) during everyday tasks? Does wearing Essilor® Stellest® lenses change working distance compared with wearing single-vision lenses? Researchers will compare the three groups to see if their working distances differ. Participants will: Complete an initial optometric eye examination. Come for a second visit where they perform everyday activities while wearing a motion-capture system that measures how they move and how far they hold objects.

Comparison of Myopic Small Incision Lenticule Extraction (SMILE) With VISUMAX 500 Versus VISUMAX 800 Platforms

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.

The Evaluation of Safety and Myopia Progression Control Using Novel Spectacle Lens

The goal of this clinical trial is to test Novel spectacle lenses in myopic children. The main question it aims to answer are: safety and efficacy of the lenses. Participants will be asked to wear spectacles and participate in eye exams and questionnaires. Researchers will compare Novel spectacle lenses and general single vision spectacle lenses to see if the Novel spectacle lenses correct myopic ametropia, slow the progression of myopia and axial elongation.

Comparing Myopia Treatments in Youth: Defocus Spectacles, Glasses, and Ortho-K

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.

The P.A.U.S.E.® Spectacle Study

The goal of this clinical trial is to learn if spectacle lenses using Phase Alteration Utilising Sub Elements (P.A.U.S.E.®) technology works to slow down the rate of myopia progression in myopic children. The first stage of the trial compares P.A.U.S.E.® spectacle lenses to single vision spectacle lenses in myopic children and the second stage looks at the rate of myopia progression in children while wearing P.A.U.S.E.® spectacle lenses. The main questions to answer are: Do P.A.U.S.E.® spectacle lenses slow down the rate of axial length growth? Do P.A.U.S.E.® spectacle lenses slow down the rate of increase in myopic refractive error? Researchers will compare P.A.U.S.E.® spectacle lenses to a single vision spectacle lens for 12 months followed by assessing P.A.U.S.E.® spectacle lenses for slowing down myopia progression for another 12 months. Participants will be initially randomly allocated to wear either P.A.U.S.E.® spectacle lenses or single vision spectacle lenses and visit the clinic on five occasions over the first 12 month period. After completing the first 12 months, all participants will wear P.A.U.S.E.® spectacle lenses and visit the clinic on three occasions over the second 12 month period.

To Study the Effects of Refractive Surgery on OCT Measurements in the Eye

Corrective eye surgeries, such as Lasik, are widely used to correct focusing problems such as myopia, or nearsightedness. Often these patients develop other conditions like myopic maculopathy or glaucoma which require monitoring with optical coherence tomography (OCT). Since OCT is a light-based test and changes the refractive status of the eye (in the cornea or the lens), it can potentially affect the results of the OCT measurements but has not been sufficiently studied. This pilot study aims at studying the potential change in OCT parameters in the eye after undergoing such surgery.

Efficacy and Safety of Myopic Macular Hole Closure Surgery Without Endotamponade Agent

Macular hole (MH) is a common condition that affects approximately 1.6/1000 elderly Chinese population. The prevalence is expected to be even higher in individuals with high myopia (HM), an established risk factor for MH. Without prompt surgical intervention, it can lead to irreversible vision loss and retinal detachment. Standard MH surgery involves pars plana vitrectomy (PPV) with internal limiting membrane (ILM peeling), followed by endotamponade agents to appose the MH edge. Office of Research and Knowledge Transfer Services Common endotamponade agents include intraocular long-acting gas and silicone oil. The use of endotamponade has its limitations, for example, impairing vision, the need for strict posturing and avoid air travel in the early postoperative period. Ocular complications, such as uveitis, cataract and glaucoma may arise. To overcome these shortcomings, a novel technique to close MH without endotamponade agents was proposed by a group from Poland. Using viscoelastics to stabilize ILM flap over the MH, negating the need and limitations of endotamponade agents. However, this case series is limited by its small sample size (12 eyes) and lack of patients with pathological myopia (PH). PH is prevalent in the Asian population and myopic MH tend to have lower surgical success rate due to antero-posterior traction from posterior staphyloma and long axial length associated with PH. There is currently a gap in evidence whether this novel surgical technique could benefit eyes with myopic MH. The investigators plan to conduct a prospective interventional case series to establish the efficacy and safety of myopic MH closure using this novel surgical technique.

Retinal Oxygen Metabolism in Children With Myopia

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.

Effects of Auricular Point Pressing With Pellets in Children With Insufficient Hyperopia Reserve

This project aims to address the trend of early onset and high myopia among children in China by focusing on insufficient hyperopia reserve, a key early warning indicator for myopia. A randomized controlled trial (RCT) will be conducted. The study will target children aged 4 to 14 with insufficient hyperopia reserve (equivalent spherical lens -0.50D to +0.75D). Through a prospective RCT design, the efficacy and safety of auricular point pressure therapy, low-concentration atropine eye drops, and their combination in delaying the onset of myopia will be systematically evaluated.

Proteomic Analysis on Myopic Children Using Orthokeratology Lenses With Good or Poor Myopic Control

The key objective of the study is to gain an understanding of the biochemical processes that contribute to orthokeratology lenses being more effective in specific individuals compared to others. With this knowledge, we hope to optimize treatment effectiveness in those currently experiencing less favorable outcomes from treatment in the future. The primary aim is to investigate differences in protein levels in children using orthokeratology lenses with various effects of myopia control. Hypothesis: There is a significant difference in the expression of molecules in children with various effects of myopia control.

S.T.O.P.® Technology Contact Lenses Versus Dual-focus Contact Lenses for Slowing Down Myopia Progression in Children

To compare the rate of myopia progression of contact lenses utilising S.T.O.P.® technology against MiSight® contact lenses.

Myopia Control Using Bright Light Therapy, Myopic Defocus and Atropine

The purpose of the study is to investigate the effect of bright light therapy, myopic defocus, atropine and the combination in myopia control in schoolchildren.

Combination Effect of Optical Defocus and Low Dose Atropine in Myopia Control

The purpose of the study is to investigate the combination effect of optical defocus and low dose atropine on myopia control in schoolchildren.

Myopia Control Efficacy of Second-generation DIMS Spectacle Lenses on Fast Progressing Myopes

The purpose of this study is to examine the efficacy and performance of the variant of Defocus Incorporated Spectacle lenses on controlling myopia progression in fast progressing myopic children.

Myopia Control Efficacy of Second-generation DIMS Spectacle Lenses on Fast Progressing Myopes - Auxiliary Group

The purpose of this study is to examine the efficacy and performance of the Defocus Incorporated Multiple Segments (DIMS) and a variant of DIMS (D2) spectacle lenses on controlling myopia progression in fast progressing myopic children.

Focus-out Glasses on Emmetropization in Chinese Children

The purpose of this study is to characterize the effects of peripheral focous-out glasses on emmetropization in non-myopic Chinese Children Aged 6-8 Years.This is a prospective, parallel-controlled randomized trial.

Dietary Supplement for Myopia Control

The purpose of this clinical trial is to investigate the changes in choroidal thickness and vasculature in myopic children following oral supplementation.

Evaluation of the Efficacy of Red Light in Adult Patients With High and Extreme Myopia

This study, led by Jie ying from the Ophthalmology Department of Beijing Tongren Hospital Affiliated to Capital Medical University, is a researcher-initiated clinical trial (IIT) designed to evaluate the therapeutic efficacy of low-intensity red light therapy in adult patients with high myopia (spherical equivalent ≤ -6.00D) and extreme myopia (spherical equivalent ≤ -10.00D). With the escalating global prevalence of high and extreme myopia-especially in East Asia including China-and pathological myopia becoming a leading cause of irreversible blindness in Chinese adults, red light therapy has shown promising effects in slowing myopia progression in children but lacks clinical evidence for adult populations, which constitutes the core rationale for this research.

Atropine Eyedrops for Myopia Progression in Children and Adolescents (MODERATO STUDY)

Myopia, or shortsightedness, is a multifactorial disorder, governed by environmental and genetic factors. Myopia is the most common ocular disorder worldwide with an increasing prevalence over the past few decades and affecting the quality of life and economic health of individuals worsening socio-economic problems. Progressive myopia is nearly exclusively a condition of childhood and adolescence, as in most young adults, myopia has stabilized. Myopia frequently appears in childhood, with a peak incidence occurring between 8 and 10 years of age. The most used topical pharmacological intervention for managing childhood myopia progression is atropine, a non-selective muscarinic antagonist, which has been widely used in clinical trials in concentrations ranging from 0.01% to 1.0%. Atropine is at present the agent with the highest efficacy and optimal safety profile to reduce myopia progression in children and adolescents. MODERATO study, a phase III, prospective, multicentric, randomized, double blind, multiple doses, placebo-controlled parallel-group, adaptive study, aims to evaluate the efficacy and safety of 0.025% and 0.05% atropine eye drops in children and adolescents aged 3 to under 18 years old over a 24-month period, to understand its ability to manage and stop myopia getting worse. It will be conducted in 11 centers in Italy, Spain, Poland, the UK and Albania.

Development of Bioluminescent Myopia Prevention and Control Instrument and Evaluation of Its Effect on Myopia

Based on the Tongren Myopia and Amblyopia Therapeutic Apparatus (a 650nm low-level red-light device) developed by the research team in the previous phase, the device was modified by replacing the light source with LED light. Subsequently, a population study was conducted to evaluate its efficacy and safety in myopia prevention and control.