CHILDREN MYOPIA CONTROL

NCT05477329 | Unknown

• 1 other identifier: MCIS2021
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is evaluating the clinical effect of a myopia control spectacle lens compared to a single vision spectacle lens in slowing down the progression of myopia in children living in Israel.

Conditions

Myopia

Keywords

MYOPIA CONTROL

Outcome Measures

Primary Outcomes (1)

• Refractive error

  Objective cycloplegic refractive error (Sphere equivalent)

  3 seconds

Secondary Outcomes (1)

• Axial length

  3 seconds

Study Arms (2)

Myopia control design spectacle lens

EXPERIMENTAL

Test lenses

Device: Lenses

Single Vision design spectacle lens

OTHER

Control lenses

Device: Lenses

Interventions

Lenses DEVICE

The test lens is manufactured in a standard FreeForm technology (exactly like a standard progressive addition lens which is similar in terms of the graduall power profile induced in both lens). It does not demand any special manufacturing processes.

Myopia control design spectacle lens; Single Vision design spectacle lens

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Informed consent form signed and fully comprehended by the parent/legal representative of the participant
• Age from 6 to 12 years old
• Both male and female
• Spherical Equivalent refractive error (cycloplegic objective) of -0.50D to -5.00D
• Astigmatism not higher than -1.50D
• Corrected Visual Acuity of not less than 6/7.5 or 20/25
• Willing to wear the trial spectacles for the defined period according the protocol plan

You may not qualify if:

• Current participation in another clinical trial
• Any general health or ocular health pathology that could affect the treatment
• Allergy or intolerance to cycloplegic eye drops (name should be stated here)
• Strabismus
• Amblyopia
• History of ocular injury or ocular surgery
• Previously been treated with any myopia control treatments (Orthokeratology, myopia control spectacle/contact lenses, multifocal lenses, bifocal lenses, atropine)

Sponsors & Collaborators

• Shamir Optical Industry Ltd: lead

Study Sites (1)

"Maor" Institute Clinic

Rishon LeZiyyon, Israel

Location

MeSH Terms

Conditions

Myopia

Interventions

Lenses

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This will be a controlled, randomized, double-masked trial. The Test group will wear the myopia control spectacle lens and the Control group will wear the single vision spectacle lens.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This will be a controlled, randomized, double-masked trial. The Test group will wear the myopia control spectacle lens and the Control group will wear the single vision spectacle lens.

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: July 28, 2022
• Study Start: June 20, 2021
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: August 1, 2022

Record last verified: 2022-07

Locations

IL (1)