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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Attaching different phase Dynamic Spatiotemporal Optical Films (S.T.O.P® KIT) when wearing spectacle frames |
|
| Control group | No Intervention | No active intervention measures |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Attaching different phase Dynamic Spatiotemporal Optical Films (S.T.O.P® KIT) when wearing spectacle frames | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the change in axial length | Difference in the change in axial length from baseline to 12 months after eyeglass fitting between the experimental group and the control group. | Baseline, 3-month, 6-month, 9-month and 12-month |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the change in spherical equivalent power | 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. | Baseline, 3-month, 6-month, 9-month and 12-month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaojuan Wang, Doctor | Contact | 19537634457 | 153803468@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Zhengzhou University | Zhenzhou | Henan | 450052 | China | ||
| Yuhuangding Hospital of Yantai |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39384214 | Result | Schmucker C, Lagreze WA. Multifocal Optics for Myopia Control. Klin Monbl Augenheilkd. 2024 Oct;241(10):1129-1133. doi: 10.1055/a-2397-1660. Epub 2024 Oct 9. | |
| 40306584 | Result | Wang M, Ma R, Kuang L, Chen X, Vincent SJ, Tan H, Lai Z, Xu S, Hu Y, Han M, Chen Q, Wang Z, Li L, Yang X. Myopia Control Efficacy of Asymmetric Multipoint Defocus Technique Spectacle Lenses: One-Year Double-Masked Randomized Controlled Trial. Ophthalmology. 2025 Sep;132(9):972-979. doi: 10.1016/j.ophtha.2025.04.022. Epub 2025 Apr 28. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 29, 2025 |
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|
| Yantai |
| Shandong |
| 264000 |
| China |
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200080 | China |
| 32519412 | Result | Choi KY, Mok AY, Do CW, Lee PH, Chan HH. The diversified defocus profile of the near-work environment and myopia development. Ophthalmic Physiol Opt. 2020 Jul;40(4):463-471. doi: 10.1111/opo.12698. Epub 2020 Jun 9. |
| 36642334 | Result | Liu J, Lu Y, Huang D, Yang J, Fan C, Chen C, Li J, Wang Q, Li S, Jiang B, Jiang H, Li X, Yang Z, Lan W. The Efficacy of Defocus Incorporated Multiple Segments Lenses in Slowing Myopia Progression: Results from Diverse Clinical Circumstances. Ophthalmology. 2023 May;130(5):542-550. doi: 10.1016/j.ophtha.2023.01.007. Epub 2023 Jan 13. |
| 17150204 | Result | Hung GK, Ciuffreda KJ. Incremental retinal-defocus theory of myopia development--schematic analysis and computer simulation. Comput Biol Med. 2007 Jul;37(7):930-46. doi: 10.1016/j.compbiomed.2006.10.004. Epub 2006 Dec 5. |
| 38418604 | Result | Tang T, Lu Y, Li X, Zhao H, Wang K, Li Y, Zhao M. Comparison of the long-term effects of atropine in combination with Orthokeratology and defocus incorporated multiple segment lenses for myopia control in Chinese children and adolescents. Eye (Lond). 2024 Jun;38(9):1660-1667. doi: 10.1038/s41433-024-02987-5. Epub 2024 Feb 28. |
| 39741002 | Result | Lembo A, Schiavetti I, Serafino M, Caputo R, Nucci P. Comparison of the performance of myopia control in European children and adolescents with defocus incorporated multiple segments (DIMS) and highly aspherical lenslets (HAL) spectacles. BMJ Paediatr Open. 2024 Dec 31;8(1):e003187. doi: 10.1136/bmjpo-2024-003187. |
| 31142465 | Result | Lam CSY, Tang WC, Tse DY, Lee RPK, Chun RKM, Hasegawa K, Qi H, Hatanaka T, To CH. Defocus Incorporated Multiple Segments (DIMS) spectacle lenses slow myopia progression: a 2-year randomised clinical trial. Br J Ophthalmol. 2020 Mar;104(3):363-368. doi: 10.1136/bjophthalmol-2018-313739. Epub 2019 May 29. |
| 40782835 | Result | Fedtke C, Chen Z, Tilia D, Li L, Chen X, Ehrmann K, Lahav-Yacouel K, Falk D, Conrad F, Tan KO, Bakaraju RC. Spatio-Temporal Optical Phase Kit for Myopia Control: Stage 1 Results from a Randomized Controlled Clinical Trial in Chinese Children. Ophthalmology. 2025 Dec;132(12):1344-1356. doi: 10.1016/j.ophtha.2025.08.001. Epub 2025 Aug 7. |
| Feb 6, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 29, 2025 | Feb 6, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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