NCT07465900

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Benha University · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Myopia Progression

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-01-15
• Primary completion: 2025-03-15
• Completion: 2025-03-15
• First posted: 2026-03-12
• Last updated: 2026-03-12

Locations

1 site across 1 country: Egypt