Clinical Research Directory

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.

Efficacy of S.T.O.P®KIT in Retarding Axial Length Growth in Children With Low Hyperopia

This is a multicenter, parallel-group, open-label, randomized controlled, superiority interventional clinical study initiated by investigators from Shanghai General Hospital (Study Protocol No.: IT-CRU-FAMB-001, Version V1.1, dated December 29, 2025), with Wang Xiaojuan as the principal investigator and the Department of Ophthalmology as the responsible department, collaborating with The First Affiliated Hospital of Zhengzhou University and Yantai Yuhuangding Hospital as participating centers. Launched on October 1, 2025, and scheduled to complete on April 1, 2027, the study aims to evaluate the efficacy of the Dynamic Spatiotemporal Optical Film (S.T.O.P®KIT) in retarding axial length growth in children with low hyperopia (primary endpoint) and compare the change in spherical equivalent power measured by autorefractometer under cycloplegia between the experimental and control groups (secondary endpoint). A total of 180 eligible children aged 6-10 years with low hyperopia will be randomly divided into the experimental group (90 cases) and the control group (90 cases) at a 1:1 ratio using simple randomization. The experimental group will receive two pairs of customized plano-spherical and plano-cylindrical glasses with S.T.O.P optical films of different phases (replaced at 6 months) and undergo follow-up every 3 months for 12 months, while the control group will only receive regular ophthalmic re-examinations without active intervention (with free dynamic optical films and customized glasses provided upon completion of all follow-ups). The study will adopt Analysis of Covariance (ANCOVA) for statistical analysis, with strict data management and quality control measures in place to ensure data authenticity and reliability, and will comply with the Declaration of Helsinki, Chinese GCP, and relevant ethical requirements to protect the safety, rights, and interests of study participants.

Safety and Effectiveness of the TENEO 317 Model 2 (1.28 US) Excimer Laser for Laser In Situ Keratomileusis (LASIK) Surgery to Treat Hyperopia With or Without Astigmatism

This will be a multicenter, prospective, open label, non-randomized, single arm 12 month study, evaluating the safety and effectiveness of the TECHNOLAS TENEO 317 Model 2 (Software version "1.28 US") excimer laser when used in LASIK surgery to treat hyperopia with or without hyperopic astigmatism. Both eyes of a subject may be enrolled so long as both eyes meet all inclusion/exclusion requirements. Analysis of the primary effectiveness endpoint will be completed at refractive stability.

Comprehensive Assessment of Multiple Products (CAMP)

The aim of this study is to assess contact lens performance and acceptance.

Assessing the Turkish DDIVAT for Visual Acuity Measurement

The goal of this observational methodological study is to validate the Turkish version of the DDIVAT visual acuity measuring device in a Turkish-speaking adult population. The main questions it aims to answer are: Does the Turkish version of the DDIVAT provide reliable and valid visual acuity measurements in Turkish speakers? Are the results of the DDIVAT comparable to those obtained with the standard Snellen chart used in clinical practice? Researchers will compare DDIVAT visual acuity test results with Snellen chart results to see if both methods produce consistent measurements. Participants will: Be adults aged 18 years or older, including both patients and healthy volunteers. Undergo visual acuity testing using the DDIVAT system displayed on a smart TV connected to the university server. Have their visual acuity re-measured using the standard Snellen optotype under the same conditions. No medication or invasive procedure will be used. The study carries no risk to participants.

Effect of Light-Blocking Lenses on Hyperopic Anisometropic Children

To evaluate the effectiveness of light-blocking lenses in promoting emmetropization and reducing anisometropia in children with hyperopic anisometropia, and to assess the impact of light-intercepting lenses on visual function in this population.

Effect of Light-Blocking Lenses on Pediatric Hyperopia

This study aims to assess the efficacy of light-blocking lenses in facilitating emmetropization in children with hyperopia and to explore their influence on various aspects of visual function.

"My Eyes, My Light": Amar Chokh, Amar Alo

Eye disease affects 2.2 billion people globally, which in turn adversely affects schooling, economic productivity, and participation in social life. The primary conditions contributing to visual impairment and blindness include cataracts, age-related macular degeneration (AMD), glaucoma, diabetic retinopathy (DR), refractive error, and presbyopia. Early detection of eye disease can provide substantial benefits in prompting treatment to reduce progression and mitigate disability. Compared with other regions, South Asia has the most cases of visual impairment due to cataracts and uncorrected refractive error. The combination of poverty, poor living and working environments, and limited health care access have long endangered eye health in Bangladesh. Coastal Bangladesh is particularly impacted by eye disease due to economic deprivation and limited healthcare access. The coastal population mostly works in fishing and agriculture, have prolonged sunlight exposure, and inadequate occupational eye protection. This low-lying region, with 35 million people, is especially vulnerable to climate disasters and global warming. High rates of chronic disease, especially diabetes mellitus Type 2 and hypertension, coupled with limited screening and treatment, shape the area's health profile, with the increasing prevalence of eye diseases such as DR, glaucoma, and visual impairment. To address the issues of poor health, accessibility, and affordability of eye care, Artificial Intelligence (AI) applications, such as Artificial Intelligence (AI)-assisted fundus imaging, can be applied in eye screening. Medical AI applications have the potential to improve the quality and efficiency of healthcare, reduce healthcare costs, optimize treatment plans, and bolster the development of primary healthcare. They can identify presumptive DR, hypertensive retinopathy (HR), AMD, and glaucoma by analyzing the retina and optic disc of fundus images with moderate accuracy and high efficiency, thus helping address the lack of local eye care professionals. Data Yakka developed a human-AI collaboration that delivers affordable and transformative community-based eye screening to underserved communities in the coastal Bangladesh region of Char Fasson. The "Amar Chokh Amar Alo" (My Eyes, My Light) initiative creates and implements comprehensive eye screening that combines AI-assisted eye screening and grassroots partnerships with trusted non-health non-governmental organizations (NGOs). It has three objectives: 1) Enhancing accessibility and affordability of eye screening; 2) Supporting high quality and efficient treatment of those problems detected via screening, 3) Collecting fundus images to refine or train AI algorithms in the future. This project was designed to evaluate the feasibility, performance, equity, and cost of this model of eye screening and its implications for global eye disease. The implementation of participant recruitment, data collection, screening, and follow-up was separated into twelve steps. This standardized framework ensured the integration of screening with data collection and follow-up eye care services. Based on risk stratification by diabetes, hypertension, age 50+ years, and/or optometrist recommendation, fundus imaging was offered selectively to higher-risk patients.

5 Year Follow up of SMILE® Procedure for the Correction of Hyperopia

The planned study will investigate and evaluate refractive stability, predictability, and safety in patients who underwent SMILE® pro surgery for hyperopia with or without astigmatism at least five years ago. This study aims to gain long-term insights into the predictability, safety, stability and side effects of the SMILE® pro procedure. It will evaluate the refractive outcome so the findings can optimize treatment nomograms and selection criteria while providing evidence of the long-term stability and predictability of the procedure. Approximately 100 patients in the Czech Republic and Germany will participate in this study. The study was reviewed and approved by an independent research ethics committee.The study will consist of a single visit, where standard, non-invasive and painless examinations will be performed. The course of this visit will correspond to the patient's last visit five years ago as part of the clinical trial

A Clinical Comparison of Proclear® 1 Day Multifocal and Clariti® 1 Day Multifocal 3 Add

The aim of this study is to compare the overall lens satisfaction between two soft multifocal contact lenses.

Clinical Trial With Artiflex Presbyopic (Artiplus)

The purpose of this clinical trial is to evaluate the effectiveness and safety of the multifocal Artiflex Presbyopic (Artiplus) intraocular lens.

The VIS Opti-K Low Vision Aid Device Provides Vision Improvement.

The VIS Opti-K Low Vision Aid device will be used to provide vision improvement to patients with refractive disorders (hyperopia and presbyopia).

Fresh Corneal Lenticule Implantation in Hyperopic Patients With High Astigmatism

The refractive combination of high hyperopia with high astigmatism is difficult to treat surgically. In addition, there are not many suitable options to offer such patients presenting with this condition. The method used at the EYE Hospital Pristina using fresh lenticule implantation by ReLex-SMILE is safe and effective method. Fresh Corneal Implantation is a safe treatment for hyperopia with high astigmatism comparing with refractive IOL implantation (loss of accommodation, endophthalmitis). Its primary objective is to increase visual acuity, accommodation process, patient satisfaction which makes patient to enjoy a happier life. We believe this study will be the future of refractive surgery for treating high hyperopia.

Treatment of Residual Refraction Errors 6 Months After Trifocal IOL Implantation With Relex-Smile

Successful treatment of residual refraction 6 months after IOL Implantation with Relex-Smile.