Clinical Research Directory

Evaluation of Mesopic Visual Acuity and Patient Satisfaction Following Ray-Tracing-Guided LASIK

To provide comprehensive evaluation of WaveLight® Plus technology by assessing impact on both functional low-light vision and patient reported outcomes

Evaluate the Efficacy and Safety of CTO0308 in Pediatric Patients With Myopia

This study was to evaluate the superiority of the myopia progression control effect in the treatment group compared with the control group, evaluated by the change in spherical equivalent (SE) after 12 months of administration of the investigational product.

Study of a Phakic Implantable Collamer Lens (ICL)

A prospective, open-labeled, single-site study of a phakic implantable collamer lens (ICL) for the correction/reduction of myopia with or without astigmatism.

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.

SMILE Surgery in One Eye Compared to Ray Tracing-guided LASIK Surgery in the Fellow Eye

Participants will undergo LASIK surgery in one eye using ray tracing guided technology in one eye and LASIK surgery in the other eye using wavefront guided technology. We are comparing outcomes between the two technologies as measured by self reported quality of vision and quality of life outcomes using validated questionnaires before and after surgery. We will also be comparing outcomes between the two technologies including measurement of low contrast visual acuity,and best spectacle corrected visual acuity.

Validation of the Vision Trainer Clinical Decision-Support Software

This study is a prospective, randomized, crossover clinical investigation designed to evaluate the accuracy, efficiency, and usability of the Vision Trainer software for subjective refraction. The study compares software-guided refraction, implemented using both Jackson Cross Cylinder (JCC) and Non-JCC workflows, against standard unassisted manual refraction performed by trained examiners

Wearing Behavior and Eye Length Changes in Children With Myopia Wearing Myopia Control Spectacle Lenses

The goal of this clinical trial is to learn how children with myopia aged 8 to 15 years move their eyes and heads during near-vision tasks while wearing different spectacle lenses, and if wearing myopia control spectacle lenses for one month is related to change in eye length (axial length). The main questions it aims to answer are: 1. How do eye gaze position and head movement patterns change when children wear the commercially available myopia control spectacle lenses compared with single-vision spectacle lenses? 2. Does wearing myopia control spectacle lenses for one month lead to short-term changes in axial length? This study compares commercially available myopia control spectacle lenses with single-vision spectacle lenses to evaluate differences in eye gaze position, head movement patterns, and axial length. Participants will: * Attend three study visits at the Singapore Polytechnic Optometry Centre. * Wear the assigned study spectacles while performing near-vision tasks. * Have video recordings of their face collected, to evaluate eye and head movements, during the near-vision tasks.

Myopia Control in Children: Comparison of Defocus Incorporated Multiple Segments® Lenses Versus Atropine 0.05% Eyedrops

Myopia is the most common refractive disorder in the world. Many strategies have been developed to control myopia in children. Among them, the instillation of low-concentration atropine eyedrops has been proven to be effective in numerous publications. Nevertheless, the spreading of atropine use is limited by: (1) its uneven availability, (2) a proportion of children with no or poor response, (3) some issues of long-term compliance (4) the possibility of a rebound effect after treatment cessation. Among the non-drug myopia control strategies, corrective lenses including the Defocus Incorporated Multiple Segments® (DIMS®) technology have demonstrated their effectiveness in a previous study (Hong Kong) when compared to monofocal lenses. The aim of this study is to compare the efficacy of DIMS lenses alone versus atropine 0.05% eyedrops + monofocal lenses, on the evolution of ocular axial length at 2 years in myopic children.

Essilor® Stellest® Lenses Multicentre European Study (SLOMES)

The goal of this post-market clinical follow up Study is to demonstrate the efficacy, safety, acceptability, and quality of life implications of Essilor® Stellest® spectacle lenses in slowing myopia progression in European children and adolescents. Participants will receive Essilor® Stellest® at inclusion visit and will be asked for a full time wear (\>12 hours daily) for 24 months. The primary endpoints are the change in axial length and cycloplegic autorefraction from baseline to 24 months compared to expected change based on axial length and refraction centile positions at baseline.

Delaying the Onset of Nearsightedness Until Treatment (DONUT) Clinical Trial

The aims of this clinical trial will test whether or not the onset of nearsightedness is delayed in a group of children randomized to nightly drops in 0.05% atropine in both eyes, in comparison to children who receiving nightly placebo drops in both eyes. The primary outcome is the two-year cumulative incidence of nearsightedness. The second aim of this project will determine whether atropine is associated with slower eye growth in children receiving nightly drops of atropine versus placebo.

A Pilot Evaluation of Refractive Error Progression in Pre-Myopic Children in Singapore With and Without Myopia Control Spectacles

This study aims to find out whether ZEISS MyoActive lenses can help prevent short-sightedness from developing in children. We aim to recruit at least 50 children in total for this study. Myopia (short-sightedness) is becoming increasingly common in children worldwide. Early onset of myopia often leads to faster progression and a higher chance of developing high myopia, which increases the risk of serious eye conditions that can affect vision in adulthood, such as retinal detachment, glaucoma, and cataracts. Current treatments can slow the worsening of short-sightedness once children become myopic, but there is limited evidence on whether early intervention can delay myopia from developing in the first place. This study will compare two types of commonly used spectacle lenses: ZEISS MyoActive lenses, which are designed to provide a type of optical signal that may reduce the worsening of short-sightedness; and Standard single-vision lenses, which are the usual lenses prescribed for clear vision. Children who join the study will be randomly assigned to wear one of these two lens types for 12 months. They will attend regular check-ups during this time so we can monitor their eye health and vision. By randomly assigning children to one of these two lens types and following them over 12 months, we aim to determine whether ZEISS MyoActive lenses: reduce the likelihood of developing short-sightedness, slow changes in how short-sighted a child's eyes are becoming and eye growth, and are safe, comfortable, and well-tolerated for everyday use. The findings from this study may help improve early myopia prevention strategies and potentially reduce future risks of high myopia and its associated eye conditions.

Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial

Pre-myopia refers to a condition in which children have not yet developed myopia but exhibit insufficient hyperopic reserve (≤ +0.75 D). This is particularly relevant for young children aged 6 years and under; if their hyperopic reserve is depleted prematurely and they progress into the pre-myopia stage, the likelihood of developing myopia or even high myopia in the future becomes extremely high. Therefore, this study plans to conduct a parallel-design, open-label, single-center randomized controlled clinical trial to evaluate the efficacy and safety of artificial intelligence-assisted defocus incorporated multiple segments (DIMS) based spectacle lens in preventing and controlling myopia in pre-myopic children aged 3 to 6 years.

Orthokeratology and 0.01% Atropine Sequential Treatment for Myopia Control

The purpose of this multicenter randomized clinical trial is to evaluate the myopia control effect of orthokeratology and 0.01% atropine sequential treatment in children and adolescents, as compared to continuous treatment with orthokeratology.

Safety and Efficacy Study of A Viscoelastic-free Method for Implantable Collamer Lens (ICL) Implantation

This study evaluates the safety and efficacy of a viscoelastic-free method for Implantable Collamer Lens(ICL) implantation to treat high myopia. The subjects undergo randomization of ICL implantation using the viscoelastic-free method on one eye and undergoing standard method on the other one. The post-operative data are collected for analysis.

Exploring Perceptual Learning in Blurred Gabor Discrimination for Low-Myopic Children

This exploratory study investigates whether perceptual learning using blurred Gabor stimuli can improve uncorrected distance visual acuity in children aged 6-10 years with low myopia. Participants will be randomly assigned to a training group or control group. The training group will undergo individualized visual perceptual learning through a digital Vision Training System (VTS) for approximately 3 months. The study will also evaluate changes in refraction, contrast sensitivity, visual crowding, Chinese reading acuity with eye movements, and sweep visual evoked potentials (sVEPs).

Assessing the Impact of Streetscape Exposure on Children's Perception

The primary objective is to determine how streetscape exposure influences children's visual perception and psychological perception. The secondary aim is to identify streetscape elements associated with both visual and psychological perception, thereby providing evidence for environmental interventions in urban planning and public health.

Slashing Two-wheeled Accidents by Leveraging Eyecare

STABLE is a stepped-wedge cluster randomised controlled trial and its primary aim is to determine whether the provision of spectacles for the correction of myopia can reduce the average number of crash-near-crash (CNC) events among eligible motorcycle drivers in Vietnam as measured under naturalistic driving conditions with the Data Acquisition System (DAS). STABLE is designed to assess the impact of vision correction on the safety of road users in a a Low and Middle income countries (LMIC) setting. A positive trial outcome would demonstrate the safety benefits of vision correction and would create pressure for tighter regulation of drivers' vision and the promotion of vision correction. The study will be conducted in the peri-urban universities in Ho Chi Minh City, Vietnam and 625 students from five universities will be recruited into the trial. Before conducting the main trial, a pilot of 35 students will be recruited to test DAS and build CNC dictionary. Duration of the trial is 33 months from enrolment to completion of primary analysis, with 18 months for data collection. Study participants can be both male and female motorcycle drivers aged 18 to 23 years years with at least one year of driving experience; they must use their motorcycle as their primary means of transport; drive at least 25 km per week and present with un- or under-corrected myopia that can be corrected with spectacles. Participants with any ocular or systemic abnormality affecting vision, other than un-or under-corrected myopia will be excluded from the trial. STABLE's primary outcome is CNC events per 1,000 km driven the DAS mounted to the motorcycles of trial participants. An interim analysis of the primary outcome will take place 9 months after data collection begins. The interim analysis will be reviewed by the trial's Data Monitoring and Ethics Committee. Unless a change is needed because of this review, the trial's primary analysis will take place 18 months after the DAS units are fitted to participants' motorcycle). Compliance with study glasses; self-reported visual function (driving-adapted Visual Function Questionnaire-25 \[VFQ-25\]); Dula Dangerous Driving Index (DDDI), for all crashes; self-reported CNC events for comparison with recorded CNC events and total delivery cost per CNC event avoided with the intervention (indicator of cost-effectiveness).

Evaluation of Orthokeratology Lenses With a 5MM Optic Zone Diameter

To evaluate the clinical performance and user-reported experience of Paragon CRT contact lenses with a 5mm Optic Zone Diameter (OZD)

China Children Eye Study

The primary objective of this multi-center, observational study is to establish the reference ranges of axial length in Chinese children and adolescents. 30,000 children aged 3-18 years were examined with cycloplegia to collect their ocular parameters and were all followed up for three years with annual visits.

School-based Myopia Prevention Trial for Children With Adequate Hyperopic Reserve

This is a prospective, school-based randomized controlled trial designed to evaluate a wearable device-supported outdoor activity program for myopia prevention in primary school students with adequate hyperopic reserve. Enrolled students in grades 1 to 4 will be randomly assigned to either a wearable device-supported outdoor activity program plus routine school-based eye health education or routine school-based eye health education alone. Outcomes will include changes in axial length and cycloplegic spherical equivalent refraction, incident myopia, intervention adherence, and safety outcomes over 12 months.

School-based Myopia Control Trial for Children With Premyopia or Myopia

This is a prospective, school-based randomized controlled trial designed to evaluate auricular acupressure combined with defocus spectacle lenses for myopia control in primary school students with premyopia or myopia. Enrolled students in grades 1 to 4 will be randomly assigned to either defocus spectacle lenses combined with auricular acupressure or defocus spectacle lenses alone. Outcomes will include changes in axial length and cycloplegic spherical equivalent refraction, adherence to the assigned intervention, and safety outcomes over 12 months.

The Rebound Effect on Repeated Low-Level Red Light Therapy for Myopia

Myopia is a global public health issue, projected to affect 49.8% of the world population by 2050, increasing risks of cataracts, glaucoma, macular degeneration, and retinal detachment. Repeated low-level red light (RLRL) therapy has shown promising myopia control in 12-month trials, reducing axial elongation by 69.4% and refractive progression by 76.6% versus spectacles, outperforming 0.01% atropine and benefiting orthokeratology poor responders. However, two-year data indicate declining efficacy in the second year and a rebound effect upon discontinuation, with progression rates matching untreated controls. This study enrolls participants who completed one year of continuous RLRL therapy to evaluate rebound effects on axial length and spherical equivalent refractive power among those who discontinue, gradually reduce, or continue treatment. Findings will inform strategies to optimize long-term RLRL protocols and mitigate post-treatment rebound.

Contact Lenses to Slow Myopia Progression in Adults

Myopia (nearsightedness) can continue to worsen during young adulthood, increasing the risk of sight-threatening eye diseases later in life. Although dual-focus soft contacts (DFSC) lenses have been shown to slow myopia progression in children, their effectiveness in adults is not well understood. This study will compare DFSC lenses with standard single-vision soft contact (SVSC) lenses in myopic young adults aged 18 to 30 years. Participants will be randomly assigned to wear one of the two lens types for 24 months. The study will measure changes in axial length and cycloplegic refractive error to determine whether DFSC lenses slow myopia progression in young adults.

School-based Myopia Prevention Trial for Children With Insufficient Hyperopic Reserve

This is a prospective, school-based randomized controlled trial designed to evaluate auricular acupressure for myopia prevention in non-myopic primary school students with insufficient hyperopic reserve. Enrolled students in grades 1 to 4 will be randomly assigned to either an auricular acupressure intervention or usual daily activities without additional study-related myopia prevention intervention. Outcomes will include changes in axial length and cycloplegic spherical equivalent refraction, incident myopia, intervention adherence, and safety outcomes over 12 months.