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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05533450
Other study ID # kjb-gmj-v1.1-20220814
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 18, 2022
Est. completion date November 30, 2024

Study information

Verified date October 2022
Source Shanghai Eye Disease Prevention and Treatment Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date November 30, 2024
Est. primary completion date October 18, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 15 Years
Eligibility Inclusion Criteria: 1. Be able to understand and sign the informed consent when accompanied by parents or guardians. 2. Age from 8 years old to15 years old. 3. The equivalent spherical lens of both eyes after ciliary muscle paralysis is -5.00D to -20.00D, the astigmatism is =-3.50D. 4. Willing to wear hard contact lenses, and able to wear only the hard contact lenses provided by the study as required and ensure adequate wearing duration. (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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Multi-focal rigid scleral contact lens
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.
Rigid gas permeable contact lens
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.

Locations

Country Name City State
China Shanghai Eye Disease Prevention & Treatment Center Shanghai Shanghai
China Shanghai Eye Disease Prevention and Treatment Center Shanghai Shanghai

Sponsors (3)

Lead Sponsor Collaborator
Shanghai Eye Disease Prevention and Treatment Center Shandong University of Traditional Chinese Medicine, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Axial length Two-year change in axial length 2 years
Secondary changes of spherical equivalent Spherical equivalent as measured by cycloplegia autorefraction 2 years
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