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

NCT05533450 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2022-10-19

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • Shandong University of Traditional Chinese Medicine

    collaborator OTHER

  • Shanghai Eye Disease Prevention and Treatment Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-18
Primary Completion
2022-10-18
Completion
2024-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05533450 on ClinicalTrials.gov