Myopia, ProgressiveCEMENCT05919654
Clinical Evaluation of MyoCare in Europe (CEME)
A study testing MyoCare and ClearView in people with Myopia, Progressive, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
A 2-year prospective, multicenter, randomized controlled, and double-blind clinical trial is used to investigate the efficacy of a new design of ophthalmic lenses to slow the progression of myopia. 300 children aged from 6 to 13 years old will be recruited and randomly assigned to a study or control group. Read more about this study
- Who is it for?
- Ages 6 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Progressive
- What is being tested?
- MyoCare and ClearView
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2022to 31 Jul 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 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 6-13 years
- Caucasian ethnicity
- Monocular/binocular decimal visual acuity with correction ≥ 1.00
- Spherical equivalent between -0.75D and -5.00D
- Astigmatism < 1.50D
- Anisometropia < 1.00D
- Evolution of at least -0.50D in one year
Who cannot join
- Presence of ocular pathology or a history of ocular and systemic abnormalities
- Strabismus or binocular vision problems
- History of eye surgery
- Having previously used some method to control myopia.
- Having contraindications for the application of drugs for cycloplegia/corneal anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of MyoCare in Europe (CEME): Study Protocol for a Prospective, Multicenter, Randomized, Double-blinded, and Controlled Clinical Trial.
A 2-year prospective, multicenter, randomized controlled, and double-blind clinical trial is used to investigate the efficacy of a new design of ophthalmic lenses to slow the progression of myopia. 300 children aged from 6 to 13 years old will be recruited and randomly assigned to a study or control group. The study group will be composed of 150 children wearing MyoCare while the control group will be composed of 150 children wearing Clearview. The inclusion criteria will be myopia with a spherical equivalent between -0.75D and -5.00D, astigmatism < 1.50D, and anisometropia < 1.00D, as well as having a historical evolution of at least -0.50 The primary outcome is to compare the mean annual progression of the spherical equivalent between both groups. The secondary outcomes are axial length, choroidal thickness, phorias, and accommodative status of both groups.
- Conditions
- Myopia, Progressive
- Being tested
- MyoCare, ClearView
- Keywords
- myopia
- Medical subject headings
- Myopia, Degenerative, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyoCareDevice
Children assigned to the study group will wear ZEISS MyoCare lenses, while those assigned to the control group will wear conventional ZEISS ClearView single-vision lenses in their spectacles. Both lenses will be made of the same material (MR8) and hard as well as anti-reflection coating (ZEISS DuraVision Platinum) and will have the same surface treatments.
ClearViewDevice
Children assigned to the study group will wear ZEISS MyoCare lenses, while those assigned to the control group will wear conventional ZEISS ClearView single-vision lenses in their spectacles. Both lenses will be made of the same material (MR8) and hard as well as anti-reflection coating (ZEISS DuraVision Platinum) and will have the same surface treatments.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Myocare Receives: Device: MyoCare |
| Control | Active comparator | Clearview Receives: Device: ClearView |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective refraction
Objective refraction will be taken after cycloplegia as the mean of 3 measurements with the i.profiler (Carl Zeiss Meditec AG, Jena, Germany) autorefractometer. The mean annual progression of the objective refraction will be compared between myopic children treated with ZEISS MyoCare lenses and those who wear a conventional single-vision lens.
Measured: 2 years
Secondary outcomes (1)
Axial length
- To compare the mean annual progression of axial length between myopic children treated with ZEISS MyoCare lenses and those who wear a conventional single-vision lens.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start15 Sep 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myopia, ProgressiveStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Cooperativa de Ensino Superior, Politécnico e Universitário, Novovision, Instituto de Cirugia Ocular, Miranza Virgen de Lujan, ICQO Instituto Quirúrgico de Oftalmología, CPO Clinica Privada de Oftalmologia, S.A., Carl Zeiss Meditec, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919654
- Sponsor's protocol ID
- UCM-MIOPIA-01
- Other IDs
- 2022-001696-14, 22/384-EC_P
- Acronym
- CEME
- Status last verified
- Jun 2023
- First submitted
- 31 May 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alvarez-Peregrina C, Sanchez-Tena MA, Villa-Collar C, Martinez-Perez C, de Corcuera-Terrero B, Liu N, Li W, Sankaridurg P, Ohlendorf A; Clinical Evaluation of MyoCare in Europe - the CEME Study Group. Clinical evaluation of MyoCare in Europe (CEME) for myopia management: One-year results. Ophthalmic Physiol Opt. 2025 Jun;45(4):1025-1035. doi: 10.1111/opo.13517. Epub 2025 Apr 29.
PubMed 40296784Alvarez-Peregrina C, Sanchez-Tena MA, Martinez-Perez C, Villa-Collar C; Clinical Evaluation of MyoCare in Europe -the CEME Study Group; Ohlendorf A. Clinical Evaluation of MyoCare in Europe (CEME): study protocol for a prospective, multicenter, randomized, double-blinded, and controlled clinical trial. Trials. 2023 Oct 17;24(1):674. doi: 10.1186/s13063-023-07696-0.
PubMed 37848908
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of MyoCare in Europe (CEME): Study Protocol for a Prospective, Multicenter, Randomized, Double-blinded, and Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT05919654
- Acronym / sponsor ID
- CEME / UCM-MIOPIA-01
- Conditions
- Myopia, Progressive
- Keywords
- myopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Cooperativa de Ensino Superior, Politécnico e Universitário, Novovision, Instituto de Cirugia Ocular, Miranza Virgen de Lujan, ICQO Instituto Quirúrgico de Oftalmología, CPO Clinica Privada de Oftalmologia, S.A., Carl Zeiss Meditec, Inc.
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 26 Jun 2023 (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.
A 2-year prospective, multicenter, randomized controlled, and double-blind clinical trial is used to investigate the efficacy of a new design of ophthalmic lenses to slow the progression of myopia. 300 children aged from 6 to 13 years old will be recruited and randomly assigned to a study or control group. The study group will be composed of 150 children wearing MyoCare while the control group will be composed of 150 children wearing Clearview. The inclusion criteria will be myopia with a spherical equivalent between -0.75D and -5.00D, astigmatism < 1.50D, and anisometropia < 1.00D, as well as having a historical evolution of at least -0.50 The primary outcome is to compare the mean annual progression of the spherical equivalent between both groups. The secondary outcomes are axial length, choroidal thickness, phorias, and accommodative status of both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: MyoCareMyocare |
| Control | Active comparator | Device: ClearViewClearview |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age 6-13 years
- Caucasian ethnicity
- Monocular/binocular decimal visual acuity with correction ≥ 1.00
- Spherical equivalent between -0.75D and -5.00D
- Astigmatism < 1.50D
Key exclusion criteria (5 listed)
- Presence of ocular pathology or a history of ocular and systemic abnormalities
- Strabismus or binocular vision problems
- History of eye surgery
- Having previously used some method to control myopia.
- Having contraindications for the application of drugs for cycloplegia/corneal anesthesia
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 |
|---|---|---|
| MyoCareChildren assigned to the study group will wear ZEISS MyoCare lenses, while those assigned to the control group will wear conventional ZEISS ClearView single-vision lenses in their spectacles. Both lenses will be made of the same material (MR8) and hard as well as anti-reflection coating (ZEISS DuraVision Platinum) and will have the same surface treatments. | Device | Treatment |
| ClearViewChildren assigned to the study group will wear ZEISS MyoCare lenses, while those assigned to the control group will wear conventional ZEISS ClearView single-vision lenses in their spectacles. Both lenses will be made of the same material (MR8) and hard as well as anti-reflection coating (ZEISS DuraVision Platinum) and will have the same surface treatments. | Device | Control |
Primary outcome
Objective refraction
Time frame: 2 years
Objective refraction will be taken after cycloplegia as the mean of 3 measurements with the i.profiler (Carl Zeiss Meditec AG, Jena, Germany) autorefractometer. The mean annual progression of the objective refraction will be compared between myopic children treated with ZEISS MyoCare lenses and those who wear a conventional single-vision lens.
1 secondary outcome
Axial length
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Derived from this study: PubMed 40296784Alvarez-Peregrina C, Sanchez-Tena MA, Villa-Collar C, Martinez-Perez C, de Corcuera-Terrero B, Liu N, Li W, Sankaridurg P, Ohlendorf A; Clinical Evaluation of MyoCare in Europe - the CEME Study Group. Clinical evaluation of MyoCare in Europe (CEME) for myopia management: One-year results. Ophthalmic Physiol Opt. 2025 Jun;45(4):1025-1035. doi: 10.1111/opo.13517. Epub 2025 Apr 29.
- Derived from this study: PubMed 37848908Alvarez-Peregrina C, Sanchez-Tena MA, Martinez-Perez C, Villa-Collar C; Clinical Evaluation of MyoCare in Europe -the CEME Study Group; Ohlendorf A. Clinical Evaluation of MyoCare in Europe (CEME): study protocol for a prospective, multicenter, randomized, double-blinded, and controlled clinical trial. Trials. 2023 Oct 17;24(1):674. doi: 10.1186/s13063-023-07696-0.
- Individual participant dataSharing planned: Undecided
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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 MyoCare and ClearView in people with Myopia, Progressive, run by Universidad Complutense de Madrid at 1 site in Spain.
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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 30 Oct 2023. 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 Spain. 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?
Results are not available in the source record.
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?
Objective refraction (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05919654, which also lists 2 linked publications.
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 30 Oct 2023.