An interventional study of Cylindrical Annular Refractive Element (C.A.R.E.) Spectacle Lenses in Myopia Progression, sponsored by Benha University. Completed at 1 site in Egypt. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-03-12.
Sponsored by Benha University · Not applicable, Interventional, and Treatment
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.
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.
Benha University is the lead sponsor of 356 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Also known as: C.A.R.E. lenses
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.
Time frame: Baseline to 12 months
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.
Time frame: Baseline to 12 months
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Benha University