Clinical trial NCT06860737: A Randomized Clinical Trial on the Effectiveness of Novel Plano Spectacle Lenses on Myopia Prevention in Pre-myopic Children
Official title: A Randomized Clinical Trial on the Effectiveness of Novel Spectacle Lenses for Myopia Prevention in Pre-myopic Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Myopic Children
Keywords: pre-myopic children
evaluation
intervention
comliance
Lead sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sponsor class: OTHER
Collaborators: name: Essilor International
First posted: 2025-03-06
Enrollment: 388
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Children aged 6-9 years old with pre-myopia are randomly assigned to a control group and an intervention group at a 1:1 ratio. The intervention group uses novel plano spectacle lenses for at least 8 hours a day, and the control group doesn't receive any intervention. The efficacy of novel plano spectacle lenses in delaying myopia onset in pre-myopia children is evaluated by comparing the one-year incidence of myopia onset between intervention group and control group.
Primary purpose: PREVENTION

Brief summary: Evaluate the efficacy, safety and wearing time compliance of novel plano spectacle lenses in delaying myopia onset in pre-myopic children and provide scientific basis for the development of myopia prevention strategies for children.

Detailed description: Children aged 6-9 years old with pre-myopia are randomly assigned to a control group and an intervention group at a 1:1 ratio. The intervention group uses novel plano spectacle lenses for at least 8 hours a day, and the control group doesn't receive any intervention. The efficacy of novel plano spectacle lenses in delaying myopia onset in pre-myopia children is evaluated by comparing the one-year incidence of myopia onset between intervention group and control group.

Eligibility criteria: Inclusion Criteria:

* At the time of signing the informed consent form, the subject's age must be ≥6 years and \<10 years (6-9.99 years);
* Both eyes are not myopic (SE\>-0.50D under cycloplegia) and at least one eye meets the pre-myopia condition ( -0.50D\< SE under cycloplegia ≤+0.75D); \[spherical equivalent (SE)=Sph+Cyl/2\]
* Astigmatism ≤1.00D in each eye;
* Difference in SER (Anisometropia) between the two eyes should not exceed ≤1.50D;
* Unaided distance and near visual acuity of at least 0.1 logMAR in each eye ;
* Be in good general health;
* Be able to actively cooperate with the intervention plan and ophthalmological examination;
* Normal binocular vision
* At least one parent with SER ≤-3.00 D

Exclusion Criteria:

* Incapable of expressing consent
* All categories of persons particularly protected by law
* Subject in another study which might have an influence on vision or interfere with study assessment.
* Previous use of other prevention solutions, such as but not limited to red light therapy within 6 months, Atropine and other interventions were used within 3 months;
* History or presence of an ocular disease, systemic disease, strabismus or amblyopia or other binocular vision abnormalities, accommodation dysfunction, cataract and eye surgery;
* Those who are allergic cycloplegic drugs;
* Other reasons that the investigator considers inappropriate for inclusion in the study.

Primary outcomes:
measure: One-year cumulative myopia incidence in either eye
timeFrame: From enrollment to the end of intervention for one year
Secondary outcomes:
measure: Changes of spherical equivalent under cycloplegia
timeFrame: From enrollment to the end of intervention for one year
measure: Changes of axial length
timeFrame: From enrollment to the end of intervention for one year
measure: Changes of choroidal thickness
timeFrame: From enrollment to the end of intervention for one year
measure: Changes of unaided distance visual acuity
timeFrame: From enrollment to the end of intervention for one year
measure: Changes of visual acuity with novel spectacle lenses and Single Vision spectacle lenses
timeFrame: From enrollment to the end of intervention for one year
measure: Changes of accommodation function
timeFrame: From enrollment to the end of intervention for one year
measure: Wearing time recorded in the questionnaire and smart frame
timeFrame: From enrollment to the end of intervention for one year
measure: Objective outdoor time recorded with smart bracelet
timeFrame: From enrollment to the end of intervention for one year
Other outcomes:
measure: Incidence and severity of adverse events (AEs) related to study intervention
timeFrame: From enrollment to the end of intervention for one year
measure: Monocular best-corrected visual acuity (BCVA)
timeFrame: From enrollment to the end of intervention for one year
measure: Assessment of symptoms, complaints related to the study intervention, as reported by participants.
timeFrame: From enrollment to the end of intervention for one year
Locations:
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