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NCT Number: NCT07401511

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.

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Key information

Conditions

Children Eye Diseases Hyperopia Refractive Errors

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Zhengzhou University, Zhenzhou, Henan, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Eligible study participants must meet all the following criteria: 1. 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.

Treatment and study plan

Attaching different phase Dynamic Spatiotemporal Optical Films (S.T.O.P® KIT) when wearing spectacle frames

Device
  • First, two pairs of eyeglasses need to be fitted, with S.T.O.P optical films of different phases attached regularly;
  • 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);
  • All lenses are plano-spherical and plano-cylindrical lenses (0D sphere, 0D cylinder);
  • Monitoring of axial length, visual acuity, and corresponding ophthalmic examinations are performed.

Primary outcomes

  1. 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

  1. Difference in the change in spherical equivalent power

    Time frame: Baseline, 3-month, 6-month, 9-month and 12-month

    Difference in the change in spherical equivalent power measured by autorefractometer under cycloplegia from baseline to 12 months after eyeglass fitting between the experimental group and the control group.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaojuan Wang, Doctor

CONTACT

[email protected]

19537634457

Sponsors and collaborators

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 10, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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