A Study on the Efficacy and Safety of Multi-focal Scleral Contact Lens

Shanghai Eye Disease Prevention and Treatment Center

Status: Not yet enrolling

Conditions: High Myopia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05533450

kjb-gmj-v1.1-20220814

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 8 to 15 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Multi-focal rigid scleral contact lens

Experimental group

Description:

During the study period, subjects will wear a multi-focal rigid scleral contact lens daily.

Treatment:

Device: Multi-focal rigid scleral contact lens

Rigid gas permeable contact lens

Active Comparator group

Description:

During the study period, the subjects will wear rigid contact lenses daily

Treatment:

Device: Rigid gas permeable contact lens