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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 180
- Locations
- 3
- Primary Endpoint
- Difference in the change in axial length
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Eligible study participants must meet all the following criteria:
- •Age: 6-10 years old;
- •+0.75D ≤ Spherical equivalent power ≤ +3.00D;
- •Anisometropia ≤ 1.50D;
- •Astigmatism ≤ 1.50D;
- •No participation in other myopia prevention and control studies or use of other myopia prevention and control methods (including low-concentration atropine eye drops, defocus eyeglasses, orthokeratology lenses, multifocal soft contact lenses, etc.) within 3 months;
- •Best-corrected visual acuity (BCVA) in both eyes ≥ 0.8 using a standard logarithmic visual acuity chart;
- •Ability to wear frame glasses during near work for at least 6 hours per day;
- •Study participants or their legal representatives sign the informed consent form.
Exclusion Criteria
- •Patients with strabismus;
- •Patients with abnormal stereopsis;
- •Comorbidity with other ophthalmic diseases, including developmental abnormalities affecting visual function and refractive status;
- •Previous ocular surgery history;
- •Previous receipt of other myopia control treatments (including orthokeratology lenses, multifocal design soft contact lenses or frame glasses, drug therapy [atropine], visual training, etc.);
- •Current use of medications that may affect pupil size and ocular surface function;
- •Comorbidity with other systemic diseases that may affect visual function or refractive status;
- •Family history of hereditary ophthalmic diseases;
- •Other conditions deemed unsuitable for participation by investigators.
Arms & Interventions
Experimental Group
Attaching different phase Dynamic Spatiotemporal Optical Films (S.T.O.P® KIT) when wearing spectacle frames
Intervention: Attaching different phase Dynamic Spatiotemporal Optical Films (S.T.O.P® KIT) when wearing spectacle frames (Device)
Control group
No active intervention measures
Outcomes
Primary Outcomes
Difference in the change in axial length
Time Frame: Baseline, 3-month, 6-month, 9-month and 12-month
Difference in the change in axial length from baseline to 12 months after eyeglass fitting between the experimental group and the control group.
Secondary Outcomes
- Difference in the change in spherical equivalent power(Baseline, 3-month, 6-month, 9-month and 12-month)
Investigators
Xiaojuan Wang
Director of the Optometry Department
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine