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

NCT07465900 | Completed

• 1 other identifier: Ophth_12\2023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myopia Progression

Keywords

Myopia Control; C.A.R.E. Lenses; Axial Elongation; Pediatric Ophthalmology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Spherical Equivalent Refractive Error (SER)

  Baseline to 12 months

Study Arms (1)

C.A.R.E. Spectacle Lenses - Pediatric Myopia Control

EXPERIMENTAL

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

Interventions

Cylindrical Annular Refractive Element (C.A.R.E.) Spectacle Lenses DEVICE

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.

Also known as: C.A.R.E. lenses

C.A.R.E. Spectacle Lenses - Pediatric Myopia Control

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University

Banhā, Benha, 13111, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Not applicable; participants, investigators, and outcome assessors were aware of the intervention.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Ophthalmology

Model Details: All participants received C.A.R.E. spectacle lenses for full-time daily wear over 12 months. No control group was included in this single-arm study.

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 12, 2026
• Study Start: January 15, 2024
• Primary Completion: March 15, 2025
• Study Completion: March 15, 2025
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

EG (1)