Clinical trial NCT06563700: Novel Lenses for Myopia Progression Trial
Official title: A Double Masked, Randomised, Longitudinal Comparative Study to Evaluate the Myopia Progression of Novel Spectacle Lenses Versus Single Vision Spectacle Lenses in Children with Myopia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia, Progressive
Lead sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 300
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center , prospective, randomised, longitudinal study to evaluate rate of myopia progression with novel lenses compared to Single-Vision spectacles. A total of 342 children will be recruited where 57 participants each are randomised to wear one of 5 test spectacle lens designs or a single vision lens (control) for 12 months. At the end of 12 months, those randomised to single vision lenses will be transferred to one of the test lenses and all the groups continued for another 12 months. Myopia progression during the second year with test lenses will be compared to historical or published controls.


Eligibility criteria: Inclusion Criteria:

be accompanied by a parent or guardian who is able to read and comprehend Chinese/English and sign a record of informed consent/assent; at baseline, be within the age range of 7 to 13 years old inclusive; be diagnosed as myopic having cycloplegic spherical equivalent between -0.75 dioptre (D) and -5.00 dioptre (D); astigmatism ≤1.50D; anisometropia of not more than 1.50D; be willing to comply with the wearing of clinical trial spectacles and clinical trial visit schedule as directed by the investigator; have ocular findings deemed to be normal; vision correctable to at least 0.8 or better in each eye with spectacles.

Exclusion Criteria:

Any pre-existing systemic or ocular condition, including infection or disease that is likely to affect visual acuity and refractive error; Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.

Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant's ocular health / physiology in an adverse or beneficial manner at enrolment and/or during the clinical trial.

History of eye trauma Amblyopia Strabismus History of use of myopia control interventions such as Orthokeratology, atropine or eye surgery 6 months prior to commencement of this trial.

Known allergy or intolerance to ingredients to cycloplegic eye-drops. Currently enrolled in another clinical trial.

Primary outcomes:
measure: myopia progression
timeFrame: 12 monthly
Secondary outcomes:
measure: axial elongation
timeFrame: 12 monthly
measure: Subjective responses and compliance
timeFrame: 12 monthly
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Eye Disease Prevention and Treatment Center
Study officials:
affiliation: Shanghai Eye Diseases Prevention and Treatment Center
name: Xiangui He
role: PRINCIPAL_INVESTIGATOR
References: