Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Evaluate the safety and effectiveness of experimental group by comparing with the control group
Compared the experimental group with the control group,the safety and effectiveness of DDM lens in mtopia control will be evaluated.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | A group of children wearing Xingyouxue Defocus Distributed Multi-point lens |
|
| control group | Active Comparator | A group of children wearing single vision lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Defocus Distributed Multi-point lens | Device | Wear DDM lens |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Objective cycloplegic refractive | Changes in objective cycloplegic refractive from baseline between two groups | baseline, 12 months |
| Changes in Axial Length | Changes in axial length from baseline between two groups | baseline, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Objective cycloplegic refractive | Changes in objective cycloplegic refractive from baseline between two groups | baseline, 6 months,18 months and 24 months |
| Changes in Axial length | Changes in axial length from baseline between two groups |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Xiaoqin Chen, MD | Tianjin Eye Hospital, Tianjin,China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Eye Hospital | Tianjin | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38503477 | Derived | Chen X, Li M, Li J, Wu M, Liu X, Yu C, Guo X, Wang Y, Wang Y, Lu W, Li L, Wang Y. One-year efficacy of myopia control by the defocus distributed multipoint lens: a multicentric randomised controlled trial. Br J Ophthalmol. 2024 Oct 22;108(11):1583-1589. doi: 10.1136/bjo-2023-324243. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Single vision lens |
| Device |
Wear single vision lens |
|
| baseline, 6 months,18 months and 24 months |
| Changes in amplitude of accommodation | Changes in amplitude of accommodation between two groups evey 6 months | baseline, 6 months,18 months and 24 months |
| Changes in near point of convergence | Changes in near point of convergence between two groups evey 6 months | baseline, 6 months,18 months and 24 months |