Myopia
Conditions
Interventions
Test group 1:Spectacle lens (polycarbonate, 1.59) with myopia control design for ZBD-6
Test group 2:Spectacle lens (polycarbonate, 1.59) with myopia control design for ZBD-7
Test group 3:Spectacle lens (Polyallyldiglycolcarbonate, CR39, 1.5) with myopia control design for ZBD-8
Control:Single vision spectacle lens (polycarbonate, 1.59)
Sponsors
Shanghai Eye Disease Prevention and Treatment Center
Eligibility
Sex/Gender
All
Age
7 Years to 14 Years
Inclusion criteria
Inclusion criteria: Participants enrolled in the clinical trial MUST: 1. Be accompanied by a parent or guardian who is able to read and comprehend Chinese/English and give informed consent/assent as demonstrated by signing a record of informed consent/assent; 2. Be able to understand and participate in the Assent process; 3. At baseline, be within the age range of 7 to 14 years old inclusive; 4. Be diagnosed as myopic having a cycloplegic spherical equivalent between -0.75 dioptre (D) and -5.00 dioptre(D); 5. Astigmatism <=1.50D; 6. Anisometropia of not more than 1.50D; 7. Be willing to comply with the wearing and clinical trial visit schedule as directed by the investigator; 8. Have ocular findings deemed to be normal; 9. Vision correctable to at least 0.8 or better in each eye with spectacles.
Exclusion criteria
Exclusion criteria: Participants enrolled in the trial MUST NOT have: 1. Any pre-existing systemic or ocular condition, including infection or disease that is likely to affect visual acuity and refractive error; 2. 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. 3. 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 either in an adverse or beneficial manner at enrolment and/or during the clinical trial. NB: Systemic antihistamines are allowed on an "as needed basis", provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used; 4. History of eye trauma; 5. Amblyopia; 6. Strabismus; 7. History of use of myopia control interventions such as Orthokeratology, atropine or eye surgery 6 months prior to commencement of this trial; 8. Known allergy or intolerance to ingredients to cycloplegic eye-drops; 9. Currently enrolled in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in objective cycloplegic spherical equivalent refractive error from baseline and between parallel study groups.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in axial length from baseline;Subjective responses and compliance; | — |
Countries
China
Contacts
Public ContactXiangui He
Shanghai Eye Disease Prevention and Treatment Center
Outcome results
None listed