MyopiaNCT06137560

Spectacle Films Utilising S.T.O.P.® Technology for Slowing Down Myopia Progression in Children

A study testing Single vision spectacle lens, Single vision spectacle lens + S.T.O.P.® Kit 1 and Single vision spectacle lens + S.T.O.P.® Kit 2 in people with Myopia, run by nthalmic Pty Ltd at 5 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 6 to 14 years
Conditions the study is for: Myopia
What is being tested?: Single vision spectacle lens, Single vision spectacle lens + S.T.O.P.® Kit 1 and Single vision spectacle lens + S.T.O.P.® Kit 2
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 210 participants
Where: 5 sitesin 2 countries
Study dates: 22 Dec 2023to Mar 2028
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 14 years
All sexes
No healthy volunteers
Child

Who may be able to join

Be between 6-14 years inclusive at time of enrolment.
Have:
Read the Informed Assent.
Been explained the Informed Assent.
Indicated an understanding of the Informed Assent.
Signed the Informed Assent.

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Have their parent / legal guardian:
Read the Informed Consent.
Been explained the Informed Consent.
Indicated an understanding of the Informed Consent.
Signed the Informed Consent.
Along with their parent / legal guardian, be capable of comprehending the nature of the study, and be willing and able to adhere to study requirements.
Along with their parent / legal guardian, agree to maintain the visit and prescribed wearing schedule.
Agree to wear allocated spectacles for a minimum of 5 days per week, at least 6 hours per day for the duration of the study and to inform the investigator if their schedule is interrupted.
Possess wearable and visually functioning spectacles.
Be in good general health, based on the parent's / legal guardian's knowledge.
Have best-corrected high contrast visual acuity based on manifest refraction of 0.10 logMAR (20/25, 6/7.6) or better in each eye.
Meet the following criteria determined by cycloplegic autorefraction at Baseline:
-5.00 D ≤ spherical equivalent ≤ -0.75 D and sphere component ≤ -0.50 DS.
-1.50 DC ≤ astigmatic component ≤ 0 DC.
|Spherical equivalent anisometropia| ≤ 1.00 D.

Who cannot join

Participant is currently, or within 30 days prior to this study, has been an active participant in another study.
Current or prior use of ANY form of myopia control, including but not limited to:
Optical devices:
Bifocal or multifocal spectacles of any type.
Bifocal or multifocal contact lenses of any type.
Orthokeratology of any type.

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Pharmacological agents:
Atropine with a concentration > 0.01%. Participants who have previously used 0.01% atropine are eligible for this study provided they agree not to use 0.01% atropine for at least 30 days before baseline and at any time during the study.
Pirenzepine
Participant born earlier than 30 weeks or weighed < 1500 g at birth.
A verbal report from the participant's parent / legal guardian is sufficient.
Habitual use of a systemic or topical medication that may alter normal ocular findings / is known to affect a participant's ocular health / physiology either in an adverse or beneficial manner at enrolment and / or during the clinical trial.
A known allergy to sodium fluorescein, benoxinate, proparacaine, tropicamide, or cyclopentolate.
Strabismus as determined by cover test at distance (≥ 3 m) or near (40 cm) while wearing distance correction under non-cycloplegic conditions.
Known ocular or systemic disease, such as but not limited to:
Diabetes.
Graves' disease.
Glaucoma.
Uveitis.
Scleritis.
Auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjogrens syndrome, and systemic lupus erythematosus.
Any ocular, systemic, or neuro-developmental conditions that could influence refractive development, such as but not limited to:
Persistent pupillary membrane.
Vitreous haemorrhage.
Cataract.
Central corneal scarring.
Eyelid haemangiomas.
Marfan's syndrome.
Down's syndrome.
Ehler's-Danlos syndrome.
Stickler's syndrome.
Ocular albinism.
Retinopathy of prematurity.
Keratoconus or irregular cornea.
The investigator may, at their discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant's best interests.

Trial locations and contacts

5 sites in 2 countries.

Country

City, postcode or hospital

5 sites in 2 countries

India3 sites

LV Prasad Eye Institute
Hyderabad, Telangana, 500034
Pristine Eye Hospitals
Hyderabad, Telangana, 500081
Divyajyoti Trust Tejas Eye Hospital
Surat, Gujarat, 394 160

Other trials in India

China2 sites

Shanghai Fudan University Eye and ENT Hospital
Shanghai, Xuhui District, 200031
Tianjin Eye Hospital
Tianjin, Heping District, 300020

Other trials in China

About this study

Official title: Spectacle Films Utilising S.T.O.P.® Technology for Slowing Down Myopia Progression in Children: A Prospective, Masked, Controlled, Randomised, Clinical Trial.

There are two parts to this trial. First, to compare the rate of myopia progression of spectacle films using Spatio Temporal Optic Phase (S.T.O.P.®) technology that provide a dynamic optical cue against single vision spectacle lenses. Second, to compare the rate of myopia progression of spectacle films using S.T.O.P.® technology that provide a dynamic optical cue against spectacle films using S.T.O.P.® technology that provide a static optical cue. A dynamic optical cue is one that changes, and a static optical cue is one that does not change.

Read the detailed description

In the first part of the trial, myopic children (6-14 years of age) will be randomly allocated to wear one of three spectacle lens options (standard single vision spectacle lenses, standard single vision spectacle lenses + S.T.O.P.® Kit 1 spectacle films, or standard single vision spectacle lenses + S.T.O.P.® Kit 2 spectacle films). S.T.O.P.® spectacle films are applied to the front surface of standard single vision spectacle lenses. Both S.T.O.P.® Kits 1 and 2 are comprised of two different sets of spectacle films applied to two different pairs of single vision spectacle lenses which are worn on alternate weeks, and thus both S.T.O.P.® Kits 1 and 2 provide a dynamic optical cue.

In the second part of this trial, participants will be randomly allocated wear of of two spectacle lens options (the best performer from S.T.O.P.® Kits 1 and 2 in terms of reducing the rate of myopic progression and single vision spectacle lenses + S.T.O.P.® film). As previously stated, both S.T.O.P.® Kits 1 and 2 provide a dynamic optical cue while S.T.O.P.® film provide a static optical cue.

The overall trial duration, including follow-up period, is expected to be approximately 42 months. Each participant's duration is expected to be approximately 30 months.

The visits are Baseline, Dispensing, 1 month, 4 months, 6 months, then visits every 6 months after.

All procedures performed at these visits are standard, non invasive clinical tests.

Conditions: Myopia
Being tested: Single vision spectacle lens, Single vision spectacle lens + S.T.O.P.® Kit 1, Single vision spectacle lens + S.T.O.P.® Kit 2, Single vision spectacle lens + S.T.O.P.® Film, Standard single vision spectacle lens + S.T.O.P.® Kit 1 or 2
Medical subject headings: Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Single vision spectacle lensDevice
Standard single vision spectacle lens
Single vision spectacle lens + S.T.O.P.® Kit 1Device
Standard single vision spectacle lens + S.T.O.P.® Kit 1
Single vision spectacle lens + S.T.O.P.® Kit 2Device
Standard single vision spectacle lens + S.T.O.P.® Kit 2
Single vision spectacle lens + S.T.O.P.® FilmDevice
Standard single vision spectacle lens + S.T.O.P.® Film
Standard single vision spectacle lens + S.T.O.P.® Kit 1 or 2Device
Standard single vision spectacle lens + S.T.O.P.® Kit 1 or 2

Study groups in NCT06137560
Study group	Role	What they receive
Assigned Intervention 1	Active comparator	Single vision spectacle lens Receives: Device: Single vision spectacle lens
Assigned Intervention 2	Experimental	Single vision spectacle lens + S.T.O.P.® Kit 1 Receives: Device: Single vision spectacle lens + S.T.O.P.® Kit 1
Assigned Intervention 3	Experimental	Single vision spectacle lens + S.T.O.P.® Kit 2 Receives: Device: Single vision spectacle lens + S.T.O.P.® Kit 2
Assigned Intervention 4	Active comparator	Static optical signal: single vision spectacle lens + S.T.O.P.® spectacle film Receives: Device: Single vision spectacle lens + S.T.O.P.® Film
Assigned Intervention 5	Experimental	Dynamic optical signal: single vision spectacle lens + S.T.O.P.® Kit 1 or 2 Receives: Device: Standard single vision spectacle lens + S.T.O.P.® Kit 1 or 2

What is being measured

The primary outcome is the main question the study is designed to answer.

Axial length
Difference in change from Baseline in axial length between single vision (control) and S.T.O.P.® Kit 1 \& 2 (tests)
Measured: Baseline, First Dispense (up to 26 days from Baseline), then 1 month, 4 months, and 6 months after First Dispense
Axial length
Difference in change from Second Dispense in axial length between static optical cue (control) and dynamic optical cue (test)
Measured: Second Dispense (up to 392 days from Baseline), then 6 months, 12 months, and 18 months after Second Dispense

Secondary outcomes (6)

Cycloplegic spherical equivalent autorefraction
Difference in change from Baseline in cycloplegic spherical equivalent autorefraction between single vision (control) and S.T.O.P.® Kit 1 \& 2 (tests)
Measured: Baseline, First Dispense (up to 26 days from Baseline), then 1 month, 4 months, and 6 months after First Dispense
Cycloplegic spherical equivalent autorefraction
Difference in change from Second Dispense in cycloplegic spherical equivalent autorefraction between static optical cue (control) and dynamic optical cue (test)
Measured: Second Dispense (up to 392 days from Baseline), then 6 months, 12 months, and 18 months after Second Dispense
Visual performance as measured by high contrast visual acuity at 6 m
Difference in visual performance between single vision (control) and S.T.O.P.® Kit 1 \& 2 (tests)
Measured: 1 month, 4 months, and 6 months after First Dispense (up to 26 days from Baseline)
Visual performance as measured by high contrast visual acuity at 6 m
Difference in visual performance between static optical cue (control) and dynamic optical cue (test)
Measured: 6 months, 12 months, and 18 months after Second Dispense (up to 392 days from Baseline)
Visual performance as measured by a non validated questionnaire based on a 1-10
Difference in visual performance between single vision (control) and S.T.O.P.® Kit 1 \& 2 (tests)
Measured: 1 month, 4 months, and 6 months after First Dispense (up to 26 days from Baseline)
Visual performance as measured by a non validated questionnaire based on a 1-10
Difference in visual performance between static optical cue (control) and dynamic optical cue (test)
Measured: 6 months, 12 months, and 18 months after Second Dispense (up to 26 days from Baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Dec 2023Mar 2028

First posted18 Nov 2023
Study start22 Dec 2023
Primary completionMar 2028 (estimated)
Study completionMar 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for MyopiaStudies of the same condition, open and under way.
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: Double blind
Who is masked: Participant, Care provider
Enrolment: 210 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06137560
Sponsor's protocol ID: nthal2021-04
Status last verified: Jun 2026
First submitted: 8 Nov 2023
Last updated: 17 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 40782835

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Spectacle Films Utilising S.T.O.P.® Technology for Slowing Down Myopia Progression in Children: A Prospective, Masked, Controlled, Randomised, Clinical Trial.
ClinicalTrials.gov ID: NCT06137560
Acronym / sponsor ID: nthal2021-04
Conditions: Myopia
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 210 participants (estimated)
Lead sponsor: nthalmic Pty LtdResearch network
Collaborators: Zhong Jing Wei Shi (Suzhou) Optical Technology Ltd.
Study start: 22 Dec 2023 (actual)
Primary completion: Mar 2028 (estimated)
Study completion: Mar 2028 (estimated)
First posted: 18 Nov 2023 (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.

Detailed description

The overall trial duration, including follow-up period, is expected to be approximately 42 months. Each participant's duration is expected to be approximately 30 months.

The visits are Baseline, Dispensing, 1 month, 4 months, 6 months, then visits every 6 months after.

All procedures performed at these visits are standard, non invasive clinical tests.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 5

Arm	Type	Receives
Assigned Intervention 1	Active comparator	Device: Single vision spectacle lensSingle vision spectacle lens
Assigned Intervention 2	Experimental	Device: Single vision spectacle lens + S.T.O.P.® Kit 1Single vision spectacle lens + S.T.O.P.® Kit 1
Assigned Intervention 3	Experimental	Device: Single vision spectacle lens + S.T.O.P.® Kit 2Single vision spectacle lens + S.T.O.P.® Kit 2
Assigned Intervention 4	Active comparator	Device: Single vision spectacle lens + S.T.O.P.® FilmStatic optical signal: single vision spectacle lens + S.T.O.P.® spectacle film
Assigned Intervention 5	Experimental	Device: Standard single vision spectacle lens + S.T.O.P.® Kit 1 or 2Dynamic optical signal: single vision spectacle lens + S.T.O.P.® Kit 1 or 2

Who may qualify

Ages: 6 to 14 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (21 listed)

Be between 6-14 years inclusive at time of enrolment.
Have:
Have their parent / legal guardian:
Along with their parent / legal guardian, be capable of comprehending the nature of the study, and be willing and able to adhere to study requirements.
Along with their parent / legal guardian, agree to maintain the visit and prescribed wearing schedule.

Key exclusion criteria (35 listed)

Participant is currently, or within 30 days prior to this study, has been an active participant in another study.
Current or prior use of ANY form of myopia control, including but not limited to:
Participant born earlier than 30 weeks or weighed < 1500 g at birth.
Habitual use of a systemic or topical medication that may alter normal ocular findings / is known to affect a participant's ocular health / physiology either in an adverse or beneficial manner at enrolment and / or during the clinical trial.
A known allergy to sodium fluorescein, benoxinate, proparacaine, tropicamide, or cyclopentolate.

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
Single vision spectacle lensStandard single vision spectacle lens	Device	Assigned Intervention 1
Single vision spectacle lens + S.T.O.P.® Kit 1Standard single vision spectacle lens + S.T.O.P.® Kit 1	Device	Assigned Intervention 2
Single vision spectacle lens + S.T.O.P.® Kit 2Standard single vision spectacle lens + S.T.O.P.® Kit 2	Device	Assigned Intervention 3
Single vision spectacle lens + S.T.O.P.® FilmStandard single vision spectacle lens + S.T.O.P.® Film	Device	Assigned Intervention 4
Standard single vision spectacle lens + S.T.O.P.® Kit 1 or 2Standard single vision spectacle lens + S.T.O.P.® Kit 1 or 2	Device	Assigned Intervention 5

Primary outcome

Axial length
Time frame: Baseline, First Dispense (up to 26 days from Baseline), then 1 month, 4 months, and 6 months after First Dispense
Difference in change from Baseline in axial length between single vision (control) and S.T.O.P.® Kit 1 \& 2 (tests)
Axial length
Time frame: Second Dispense (up to 392 days from Baseline), then 6 months, 12 months, and 18 months after Second Dispense
Difference in change from Second Dispense in axial length between static optical cue (control) and dynamic optical cue (test)

6 secondary outcomes

Cycloplegic spherical equivalent autorefraction
Time frame: Baseline, First Dispense (up to 26 days from Baseline), then 1 month, 4 months, and 6 months after First Dispense
Cycloplegic spherical equivalent autorefraction
Time frame: Second Dispense (up to 392 days from Baseline), then 6 months, 12 months, and 18 months after Second Dispense
Visual performance as measured by high contrast visual acuity at 6 m
Time frame: 1 month, 4 months, and 6 months after First Dispense (up to 26 days from Baseline)
Visual performance as measured by high contrast visual acuity at 6 m
Time frame: 6 months, 12 months, and 18 months after Second Dispense (up to 392 days from Baseline)
Visual performance as measured by a non validated questionnaire based on a 1-10
Time frame: 1 month, 4 months, and 6 months after First Dispense (up to 26 days from Baseline)
Visual performance as measured by a non validated questionnaire based on a 1-10
Time frame: 6 months, 12 months, and 18 months after Second Dispense (up to 26 days from Baseline)

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 17 Jun 2026.
Derived from this study: 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

Related trials for Myopia

Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
Recruiting
Mobility Performance in Daily Activities Among Children Wearing Spectacle Lenses
Myopia, Myopia Progression
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
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Not yet recruiting
The EYERISING Study
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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. This study is not recruiting at the moment.

Daniel Tilia, Optom, PhD principal investigator

nthalmic Pty Ltd

5 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 21 inclusion and 35 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: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in India, 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Axial length (time frame: Baseline, First Dispense (up to 26 days from Baseline), then 1 month, 4 months, and 6 months after First Dispense). The study lists 2 primary outcomes in all. 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 NCT06137560, which also lists 1 linked publication.

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 17 Jun 2026.