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This study aims to evaluate the effectiveness and acceptability of dual-focus soft contact lenses in controlling rapid myopia progression in adults through a randomized controlled trial. By applying myopia control measures to the adult population, we hope to provide scientific evidence for the effective control of adult myopia progression and offer insights into the understanding of myopia progression during early adulthood.
It has long been believed that the progression of myopia mainly occurs during the elementary to high school stages. However, some studies and clinical practice suggest that a considerable proportion of adults still experience myopia progression in their adulthood, especially in those who have prolonged near work or screen usage time. At present, there is insufficient evidence on whether these population needs myopia control intervention. Most adults experiencing myopia progression do not receive appropriate myopic intervention measures, leading to an increase of dioptre, which may affect the quality of daily life, and raise the risk of high myopia and blinding myopia complications.
This study aims to evaluate the effectiveness and acceptability of dual-focus soft contact lenses in controlling rapid myopia progression in adults through a randomized controlled trial. By applying myopia control measures to the adult population, we hope to provide scientific evidence for the effective control of adult myopia progression and offer insights into the understanding of myopia progression during early adulthood.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual-focus CL | Experimental | Wearing dual-focus CL for 2 years |
|
| Single-vision CL | Placebo Comparator | Wearing single-vision CL for 2 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MiSight® 1 day soft contact lenses | Device | Dual-focus contact lenses, daily disposable, material: omafilcon A, water content: 60%. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in cycloplegic spherical equivalent after 2 years | The difference in the change of cycloplegic spherical equivalent between the intervention group and the control group. | 2 years after the baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in axial length after 2 years | The difference in the change of axial length between the intervention group and the control group. | 2 years after the baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiangui He | Contact | (86)15000755422 | xianhezi@163.com | |
| Hotin Wu | Contact | (86)19821287621 | 24499980@sjtu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiangui He | Shanghai Eye Disease Prevention & Treatment Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Eye Disease Prevention & Treatment Center | Shanghai | Shanghai Municipality | 200041 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32915454 | Background | Ruiz-Pomeda A, Villa-Collar C. Slowing the Progression of Myopia in Children with the MiSight Contact Lens: A Narrative Review of the Evidence. Ophthalmol Ther. 2020 Dec;9(4):783-795. doi: 10.1007/s40123-020-00298-y. Epub 2020 Sep 11. | |
| 37126362 | Background | Bullimore MA, Lee SS, Schmid KL, Rozema JJ, Leveziel N, Mallen EAH, Jacobsen N, Iribarren R, Verkicharla PK, Polling JR, Chamberlain P. IMI-Onset and Progression of Myopia in Young Adults. Invest Ophthalmol Vis Sci. 2023 May 1;64(6):2. doi: 10.1167/iovs.64.6.2. |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D003263 | Contact Lenses, Hydrophilic |
| ID | Term |
|---|---|
| D003261 | Contact Lenses |
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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Intervention Group: Daily disposable bifocal soft corneal contact lenses: MiSight® 1 day soft contact lens (CooperVision, material: omafilcon A, water content: 60%).
Control Group: Daily disposable single-focus soft corneal contact lenses: Proclear® 1 day soft contact lens (CooperVision, material: omafilcon A, water content: 60%)
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This study will utilize a Central Randomization System (CRS) for the random grouping and glasses allocation of study subjects during the clinical trial. Investigators and participants will be blinded to the intervention received until unblinding.
| Proclear® 1 day soft contact lenses | Device | Single-vision contact lenses, daily disposable, material: omafilcon A, water content: 60%. |
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