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

High Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05533450
• Other study ID #: kjb-gmj-v1.1-20220814
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 18, 2022
• Est. completion date: November 30, 2024

Study information

• Verified date: October 2022
• Source: Shanghai Eye Disease Prevention and Treatment Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: November 30, 2024
• Est. primary completion date: October 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• High Myopia
• Myopia

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Shanghai Eye Disease Prevention & Treatment Center	Shanghai	Shanghai
China	Shanghai Eye Disease Prevention and Treatment Center	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai Eye Disease Prevention and Treatment Center	Shandong University of Traditional Chinese Medicine, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axial length	Two-year change in axial length	2 years
Secondary	changes of spherical equivalent	Spherical equivalent as measured by cycloplegia autorefraction	2 years