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

NCT05533450 | Unknown DMC

• 1 other identifier: kjb-gmj-v1.1-20220814
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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

Keywords

high myopia; children and adolescents; defocus; scleral contact lens

Outcome Measures

Primary Outcomes (1)

• Axial length

  Two-year change in axial length

  2 years

Secondary Outcomes (1)

• changes of spherical equivalent

  2 years

Study Arms (2)

Multi-focal rigid scleral contact lens

EXPERIMENTAL

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

Device: Multi-focal rigid scleral contact lens

Rigid gas permeable contact lens

ACTIVE COMPARATOR

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

Device: Rigid gas permeable contact lens

Interventions

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.

Also known as: OVCTEK

Multi-focal rigid scleral contact lens

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.

Also known as: OVCTEK

Rigid gas permeable contact lens

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Be able to understand and sign the informed consent when accompanied by parents or guardians.
• Age from 8 years old to15 years old.
• The equivalent spherical lens of both eyes after ciliary muscle paralysis is -5.00D to -20.00D, the astigmatism is ≤-3.50D.
• 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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Shandong University of Traditional Chinese Medicine: collaborator

Study Sites (2)

Shanghai Eye Disease Prevention & Treatment Center

Shanghai, Shanghai Municipality, 200040, China

Location

Shanghai Eye Disease Prevention and Treatment Center

Shanghai, Shanghai Municipality, 200041, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: September 9, 2022
• Study Start: October 18, 2022
• Primary Completion: October 18, 2022
• Study Completion: November 30, 2024
• Last Updated: October 19, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)