Status:
ACTIVE_NOT_RECRUITING
Novel Lenses for Myopia Progression Trial
Lead Sponsor:
Shanghai Eye Disease Prevention and Treatment Center
Conditions:
Myopia, Progressive
Eligibility:
All Genders
7-13 years
Phase:
NA
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 recr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06563700
Start Date
August 16 2024
End Date
July 31 2027
Last Update
December 3 2025
Active Locations (1)
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1
Shanghai Eye Disease Prevention and Treatment Center
Shanghai, China