Slowing Axial Elongation in Pediatric Myopia Using C.A.R.E. Technology (MyoCARE)

Slowing Axial Elongation in Pediatric Myopia: One-Year Clinical Outcomes of Cylindrical Annular Refractive Elements (C.A.R.E.) Technology

This prospective interventional study evaluates the effectiveness of Cylindrical Annular Refractive Element (C.A.R.E.) spectacle lenses in slowing axial elongation and myopia progression in children aged 6-12 years. A total of 100 participants with myopia ranging from -0.75 to -6.00 diopters were enrolled and prescribed C.A.R.E. spectacle lenses for full-time wear over a 12-month period. Clinical examinations are conducted at baseline, 6 months, and 12 months and include measurements of axial length, cycloplegic refraction, and visual acuity.

The primary outcome measure is the change in axial length over the 12-month study period. Secondary outcomes include changes in spherical equivalent refractive error, visual acuity, and safety outcomes related to spectacle lens wear.

Study Overview

• Status: Completed
• Conditions: Myopia Progression
• Intervention / Treatment: Device: Cylindrical Annular Refractive Element (C.A.R.E.) Spectacle Lenses

Detailed Description

This prospective interventional clinical study was designed to evaluate the effectiveness of Cylindrical Annular Refractive Element (C.A.R.E.) spectacle lenses in slowing axial elongation in children with myopia over a one-year period. The study follows the principles of the Declaration of Helsinki and received approval from the Al-Azhar University Institutional Ethics Committee (Approval No. Ophth._12/2023). Written informed consent was obtained from the parents or legal guardians of all participants prior to enrollment.

Participants

A total of 100 children aged 6-12 years with spherical equivalent refractive error between -0.75 and -6.00 diopters and astigmatism ≤1.50 diopters were recruited. Eligible participants were required to have best-corrected visual acuity of 0.1 logMAR or better and no history of ocular pathology or previous ocular surgery.

Children with amblyopia, strabismus, keratoconus, previous myopia control treatment (such as atropine therapy or orthokeratology), or poor compliance with spectacle wear were excluded.

Intervention

All participants were prescribed spectacle lenses incorporating Cylindrical Annular Refractive Element (C.A.R.E.) technology. These lenses contain a central optical zone for distance correction surrounded by concentric annular cylindrical elements designed to modify peripheral retinal defocus. Participants were instructed to wear the spectacles full-time during waking hours throughout the study period.

Study Procedures

Participants undergo comprehensive ophthalmologic examinations at baseline, 6 months, and 12 months. Assessments include:

Uncorrected visual acuity (UCVA)

Best-corrected visual acuity (BCVA)

Cycloplegic refraction

Axial length measurement using non-contact optical biometry

Outcome Measures

The primary outcome measure is the change in axial length over the 12-month follow-up period. Secondary outcomes include changes in spherical equivalent refractive error, visual acuity, and safety outcomes associated with spectacle lens wear.

Statistical Analysis

Statistical analysis will be performed using SPSS software. Continuous variables will be expressed as mean ± standard deviation. Data distribution will be evaluated using the Shapiro-Wilk test. Changes in axial length and refractive error over time will be analyzed using repeated-measures analysis of variance (ANOVA) or paired statistical tests when appropriate. A p-value less than 0.05 will be considered statistically significant.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Benha
    • Banhā, Benha, Egypt, 13111
      • Benha University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Children aged 6-12 years at enrollment.
• Spherical equivalent refractive error between -0.75 and -6.00 diopters.
• Astigmatism ≤1.50 diopters.
• Best-corrected visual acuity of 0.1 logMAR or better.
• Ability to comply with full-time spectacle wear.
• Informed consent obtained from parent or legal guardian.

Exclusion Criteria:

• Amblyopia or strabismus.
• Keratoconus or other corneal pathology.
• Previous myopia control treatment (e.g., atropine therapy, orthokeratology).
• History of ocular surgery.
• Systemic disease affecting vision.
• Poor compliance with spectacle wear.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: C.A.R.E. Spectacle Lenses - Pediatric Myopia Control; All participants received Cylindrical Annular Refractive Element (C.A.R.E.) spectacle lenses. The lenses feature a central optical zone for distance correction surrounded by concentric annular cylindrical elements designed to modify peripheral retinal defocus and slow axial elongation. Participants were instructed to wear the spectacles full-time during waking hours for 12 months. Follow-up examinations occurred at baseline, 6 months, and 12 months to assess axial length, refractive error, visual acuity, and safety.

Device: Cylindrical Annular Refractive Element (C.A.R.E.) Spectacle Lenses; C.A.R.E. spectacle lenses feature a central optical zone for distance correction surrounded by concentric annular cylindrical elements that modify peripheral retinal defocus to slow axial elongation in children with myopia. Participants were instructed to wear the lenses full-time during waking hours for 12 months. Follow-up assessments were conducted at baseline, 6 months, and 12 months, measuring axial length, refractive error, visual acuity, and safety.; Other Names: C.A.R.E. lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Axial Length	Axial length (AL) will be measured using non-contact optical biometry at baseline, 6 months, and 12 months. The primary outcome is the difference in axial length from baseline to 12 months to evaluate the effect of C.A.R.E. lenses on slowing ocular elongation in children with myopia.	Baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Spherical Equivalent Refractive Error (SER)	SER measured under cycloplegia using an autorefractor at baseline, 6 months, and 12 months to assess myopia progression.	Baseline to 12 months

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Actual): March 15, 2025
• Study Completion (Actual): March 15, 2025

Study Registration Dates

• First Submitted: March 6, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Pediatric Ophthalmology; Myopia Control; C.A.R.E. Lenses; Axial Elongation
• Other Study ID Numbers: Ophth_12\2023

Drug and device information, study documents

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