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Efficacy of S.T.O.P®KIT in Retarding Axial Length Growth in Children With Low Hyperopia
Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Summary
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.
Official title: A Multicenter, Randomized Controlled Clinical Study Evaluating the Efficacy of Dynamic Spatiotemporal Optical Film (S.T.O.P®KIT) in Retarding Axial Length Growth in Children With Low Hyperopia
Key Details
Gender
All
Age Range
6 Years - 10 Years
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2026-02-01
Completion Date
2027-08-01
Last Updated
2026-02-10
Healthy Volunteers
Yes
Interventions
Attaching different phase Dynamic Spatiotemporal Optical Films (S.T.O.P® KIT) when wearing spectacle frames
1. First, two pairs of eyeglasses need to be fitted, with S.T.O.P optical films of different phases attached regularly; 2. Follow-up visits are conducted every 3 months, and eyeglasses are replaced at 6 months (with changes in S.T.O.P optical film design and phase); 3. All lenses are plano-spherical and plano-cylindrical lenses (0D sphere, 0D cylinder); 4. Monitoring of axial length, visual acuity, and corresponding ophthalmic examinations are performed.
Locations (3)
The First Affiliated Hospital of Zhengzhou University
Zhenzhou, Henan, China
Yuhuangding Hospital of Yantai
Yantai, Shandong, China
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China