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

A Multicenter Randomized Controlled Study on the Efficacy and Safety of Multi-focal Scleral Contact Lens in the Treatment of Ultra-high Myopia in Children and Adolescents

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.

Study Overview

• Status: Not yet recruiting
• Conditions: High Myopia
• Intervention / Treatment: Device: Multi-focal rigid scleral contact lens; Device: Rigid gas permeable contact lens

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Shanghai Eye Disease Prevention & Treatment Center
    • Shanghai, Shanghai, China, 200041
      • Shanghai Eye Disease Prevention and Treatment Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multi-focal rigid scleral contact lens; During the study period, subjects will wear a multi-focal rigid scleral contact lens daily.	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.; Other Names: OVCTEK
Active Comparator: Rigid gas permeable contact lens; During the study period, the subjects will wear rigid contact lenses daily	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.; Other Names: OVCTEK

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial length	Two-year change in axial length	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes of spherical equivalent	Spherical equivalent as measured by cycloplegia autorefraction	2 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): October 18, 2022
• Primary Completion (Anticipated): October 18, 2022
• Study Completion (Anticipated): November 30, 2024

Study Registration Dates

• First Submitted: September 5, 2022
• First Submitted That Met QC Criteria: September 5, 2022
• First Posted (Actual): September 9, 2022

Study Record Updates

• Last Update Posted (Actual): October 19, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: children and adolescents; high myopia; defocus; scleral contact lens
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: kjb-gmj-v1.1-20220814

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No