Myopia, Progressive
Conditions
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.
Interventions
OTHERspectacle lens
one of ZEISS BD spectacle lens designs 1 to 5
OTHERsingle vision lens
single vision lens
Sponsors
Shanghai Eye Disease Prevention and Treatment Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
7 Years to 13 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| myopia progression | 12 monthly | change in spherical equivalent from baseline for each of the groups of BD test lenses and the single vision control group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| axial elongation | 12 monthly | change in axial length from baseline for each of the groups of BD test lenses and the single vision control group |
| Subjective responses and compliance | 12 monthly | Subjective visual responses of wearing spectacles and compliance using questionair for each groups |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORXiangui He
Shanghai Eye Diseases Prevention and Treatment Center
Outcome results
None listed