ChildrenNCT07401511
Efficacy of S.T.O.P®KIT in Retarding Axial Length Growth in Children With Low Hyperopia
A study testing Attaching different phase Dynamic Spatiotemporal Optical Films (S.T.O.P® KIT) when wearing spectacle frames in people with Children and Hyperopia, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 3 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- What is being tested?
- Attaching different phase Dynamic Spatiotemporal Optical Films (S.T.O.P® KIT) when wearing spectacle frames
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 3 sitesChina
- Study dates
- 1 Feb 2026to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200080
Yuhuangding Hospital of Yantai
Yantai, Shandong, 264000
The First Affiliated Hospital of Zhengzhou University
Zhenzhou, Henan, 450052
About this study
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
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.
- Being tested
- Attaching different phase Dynamic Spatiotemporal Optical Films (S.T.O.P® KIT) when wearing spectacle frames
- Keywords
- children, axial length, low hyperopia, spherical equivalent, Dynamic Spatiotemporal Optical Film
- Medical subject headings
- Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attaching different phase Dynamic Spatiotemporal Optical Films (S.T.O.P® KIT) when wearing spectacle framesDevice
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Attaching different phase Dynamic Spatiotemporal Optical Films (S.T.O.P® KIT) when wearing spectacle frames Receives: Device: Attaching different phase Dynamic Spatiotemporal Optical Films (S.T.O.P® KIT) when wearing spectacle frames |
| Control group | No intervention | No active intervention measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3-month, 6-month, 9-month and 12-month
Secondary outcomes (1)
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.
Measured: Baseline, 3-month, 6-month, 9-month and 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ChildrenStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaojuan Wang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401511
- Sponsor's protocol ID
- 20250924101843325
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39384214Wang 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.
PubMed 40306584Choi 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.
PubMed 32519412Liu 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.
PubMed 36642334Hung 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.
PubMed 17150204Tang 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.
PubMed 38418604Lembo 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.
PubMed 39741002Lam 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.
PubMed 31142465Fedtke 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.
PubMed 40782835
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07401511
- Acronym / sponsor ID
- 20250924101843325
- Keywords
- children, axial length, low hyperopia, spherical equivalent, Dynamic Spatiotemporal Optical Film
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Attaching different phase Dynamic Spatiotemporal Optical Films (S.T.O.P® KIT) when wearing spectacle framesAttaching different phase Dynamic Spatiotemporal Optical Films (S.T.O.P® KIT) when wearing spectacle frames |
| Control group | No intervention | –No active intervention measures |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (9 listed)
- 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.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Attaching different phase Dynamic Spatiotemporal Optical Films (S.T.O.P® KIT) when wearing spectacle frames1. 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. | Device | Experimental Group |
Primary outcome
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.
1 secondary outcome
Difference in the change in spherical equivalent power
Time frame: Baseline, 3-month, 6-month, 9-month and 12-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Results publication: PubMed 39384214Schmucker 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.
- Results publication: PubMed 40306584Wang 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.
- Results publication: PubMed 32519412Choi 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.
- Results publication: PubMed 36642334Liu 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.
- Results publication: PubMed 17150204Hung 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.
- Results publication: PubMed 38418604Tang 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.
- Results publication: PubMed 39741002Lembo 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.
- Results publication: PubMed 31142465Lam 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.
- Results publication: PubMed 40782835Fedtke 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attaching different phase Dynamic Spatiotemporal Optical Films (S.T.O.P® KIT) when wearing spectacle frames in people with Children and Hyperopia, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaojuan Wang, Doctor (19537634457, 153803468@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the change in axial length (time frame: Baseline, 3-month, 6-month, 9-month and 12-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07401511, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.