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| Name | Class |
|---|---|
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| Shandong University of Traditional Chinese Medicine | OTHER |
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The rigid scleral contact lens with optical multi-focal design adopted in this study can focus the light in part of the optical area on the front of the retina to form myopic defocus, in order to delay the axial changes in children and adolescents with ultra-high myopia. In this study, RGP was used as a control, and a multicenter, randomized, controlled trial was conducted to verify the safety and effectiveness of multifocal scleral contact lenses for the correction of ultra-high myopia in children and adolescents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-focal rigid scleral contact lens | Experimental | During the study period, subjects will wear a multi-focal rigid scleral contact lens daily. |
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| Rigid gas permeable contact lens | Active Comparator | During the study period, the subjects will wear rigid contact lenses daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-focal rigid scleral contact lens | Device | True scleral lenses rest on the sclera and do not touch the cornea and limbus, leaving a clear area between the contact lens and the cornea. |
| Measure | Description | Time Frame |
|---|---|---|
| Axial length | Two-year change in axial length | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| changes of spherical equivalent | Spherical equivalent as measured by cycloplegia autorefraction | 2 years |
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Inclusion Criteria:
(6) Best corrected visual acuity of both eyes ≥ 0.8.
Exclusion Criteria:
(1) Allergic or intolerant to rigid contact lens or its care products or ciliary muscle paralysis drugs.
Strabismus and/or amblyopia. (3) Those who have worn hard contact lenses in the past 30 days are using atropine, defocus frame lens, bifocal lens or progressive lens, acupuncture, etc. for myopia treatment.
(4) Any clinically significant active eye disease, such as glaucoma, uveitis, chorioretinitis, central retinal artery or vein occlusion, and so on.
(5) Patients with systemic diseases that may affect the wearing of hard contact lenses, such as hyperthyroidism, diabetes, mental illness, and so on.
(6) are using drugs that affect their eye health. (7) History of eye injury or surgery. (8) Incapacitated or unable to follow the visitor as required. (9) Other conditions not suitable for inclusion as judged by the investigator.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Eye Disease Prevention & Treatment Center | Shanghai | Shanghai Municipality | 200040 | China | ||
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| Rigid gas permeable contact lens | Device | RGP contact lens is designed from a special rigid hydrophobic material. Patients wear RGP contact lens to form a "contact lens-tear-cornea" system to correct irregular astigmatism, reduce aberrations, provide good visual quality, and control the development of the disease through mild "shaping" effect. |
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| Shanghai Eye Disease Prevention and Treatment Center |
| Shanghai |
| Shanghai Municipality |
| 200041 |
| China |