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

NCT ID: NCT05533450

Last Updated: 2022-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-18
• Study Completion Date: 2024-11-30

Brief 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.

Conditions

High Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Multi-focal rigid scleral contact lens

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

Group Type: EXPERIMENTAL

Multi-focal rigid scleral contact lens

Intervention Type: 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.

Rigid gas permeable contact lens

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

Group Type: ACTIVE_COMPARATOR

Rigid gas permeable contact lens

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Other Intervention Names

OVCTEK; OVCTEK

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: collaborator

Shandong University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Shanghai Eye Disease Prevention and Treatment Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Eye Disease Prevention & Treatment Center

Shanghai, Shanghai Municipality, China

Shanghai Eye Disease Prevention and Treatment Center

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

kjb-gmj-v1.1-20220814

Identifier Type: -

Identifier Source: org_study_id