Last reviewed · How we verify
NCT07401511
Efficacy of S.T.O.P®KIT in Retarding Axial Length Growth in Children With Low Hyperopia
NA trial testing Attaching different phase Dynamic Spatiotemporal Optical Films (S.T.O.P® KIT) when wearing spectacle frames in Children in 180 participants. Not yet recruiting.
1 July 2027
Quick facts
| Lead sponsor | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 180 |
| Start date | 1 February 2026 |
| Primary completion | 1 July 2027 |
| Estimated completion | 1 August 2027 |
| Sites | 3 locations across China |
Drugs / interventions tested
- Attaching different phase Dynamic Spatiotemporal Optical Films (S.T.O.P® KIT) when wearing spectacle frames
Conditions studied
Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Who can join
Adults 6 to 10, any sex, with Children or Hyperopia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07401511
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Children
Currently open trials in the same condition.
- NCT07404163 — Walkway Used in Postoperative Mobilization · NA · active not recruiting
- NCT07193719 — Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children · Phase 1, PHASE2 · recruiting
- NCT07428837 — Effect of Cognitive-motor Training Versus Pilates Exercises on Postural Stability in Down Syndrome. · NA · recruiting
- NCT07482371 — Comparative Effects of Scooping Mobilization and Dynamic Cupping Therapy on Elbow Stiffness · NA · recruiting
- NCT07278960 — Enhancing Management Algorithms for Children Conceived Via Assisted Reproductive Technologies · recruiting
Other Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine trials
Trials by the same sponsor.
- NCT06667466 — New Laser and Suction Sheath for Kidney Stone Treatment · not yet recruiting
- NCT07043374 — Impact of Humid-Heat on Gut-Tryptophan-Stone Pathway · not yet recruiting
- NCT07415226 — Glucose-lowering Drugs as an Adjunct to Insulin Therapy in Chinese Patients With Type 1 Diabetes · not yet recruiting
- NCT07469046 — VAH vs VA in Newly Diagnosed Elderly AML · Phase 3 · not yet recruiting
- NCT07439120 — Safety and Tolerability Study of 68Ga/177Lu-BRP-020063 in Advanced Solid Tumors · EARLY_PHASE1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07401511 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Last refreshed: 10 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07401511.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing