Myopia ProgressionMyoCARENCT07465900
Slowing Axial Elongation in Pediatric Myopia Using C.A.R.E. Technology
A study testing Cylindrical Annular Refractive Element (C.A.R.E.) Spectacle Lenses in people with Myopia Progression, run by Benha University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Myopia Progression
- What is being tested?
- Cylindrical Annular Refractive Element (C.A.R.E.) Spectacle Lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2024to 15 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Cylindrical Annular Refractive Element (C.A.R.E.) Spectacle Lenses
- Keywords
- Myopia Control, C.A.R.E. Lenses, Axial Elongation, Pediatric Ophthalmology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cylindrical Annular Refractive Element (C.A.R.E.) Spectacle LensesDevice
Also called C.A.R.E. 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Cylindrical Annular Refractive Element (C.A.R.E.) Spectacle Lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 months
Secondary outcomes (1)
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.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start15 Jan 2024
- Primary completion15 Mar 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopia ProgressionStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Mohamed Elsayed Mohamed Saad, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465900
- Sponsor's protocol ID
- Ophth_12\2023
- Acronym
- MyoCARE
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Slowing Axial Elongation in Pediatric Myopia: One-Year Clinical Outcomes of Cylindrical Annular Refractive Elements (C.A.R.E.) Technology
- ClinicalTrials.gov ID
- NCT07465900
- Acronym / sponsor ID
- MyoCARE / Ophth_12\2023
- Conditions
- Myopia Progression
- Keywords
- Myopia Control, C.A.R.E. Lenses, Axial Elongation, Pediatric Ophthalmology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| C.A.R.E. Spectacle Lenses - Pediatric Myopia Control | Experimental | Device: Cylindrical Annular Refractive Element (C.A.R.E.) Spectacle LensesAll 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cylindrical Annular Refractive Element (C.A.R.E.) Spectacle LensesAlso: C.A.R.E. lensesC.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. | Device | C.A.R.E. Spectacle Lenses - Pediatric Myopia Control |
Primary outcome
Change in Axial Length
Time frame: Baseline to 12 months
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.
1 secondary outcome
Change in Spherical Equivalent Refractive Error (SER)
Time frame: Baseline to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cylindrical Annular Refractive Element (C.A.R.E.) Spectacle Lenses in people with Myopia Progression, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Axial Length (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.