New glasses film may help Kids' eyesight stop getting worse
NCT ID NCT06137560
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests special spectacle films designed to slow down myopia (nearsightedness) in children. About 210 kids aged 6 to 14 are taking part. The films use a new technology called S.T.O.P.® that creates changing visual cues, which may help control how fast the eye grows and prevent vision from worsening.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 210 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Dec 2023
- Expected to finish
-
Mar 2028
An estimate. End dates often move.
- Lead sponsor
-
A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
6 to 14 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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. * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Myopia are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Divyajyoti Trust Tejas Eye Hospital
Surat, Gujarat, 394 160, India
-
LV Prasad Eye Institute
Hyderabad, Telangana, 500034, India
-
Pristine Eye Hospitals
Hyderabad, Telangana, 500081, India
-
Shanghai Fudan University Eye and ENT Hospital
Shanghai, Xuhui District, 200031, China
-
Tianjin Eye Hospital
Tianjin, Heping District, 300020, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can AI protect Kids' eyesight where eye doctors are scarce?
- Two toric lenses go head to head in vision test
- Eye scans as a window to the body: study probes retinal imaging across diseases
- Lens showdown: which contact lens wins in dim light?
- Myopia glasses may keep working even after kids take them off
- Can glasses that slow nearsightedness also reshape a Child's astigmatism?