Myopia ProgressionPRIMENCT07394556
Prospective Research on the Intervention of Myoless2.0 Effectiveness (PRIME) in Pediatric Population
An observational study of Myopia Progression, run by Indizen Optical Technologies, S.L.U. at 3 sites in 3 countries.
Trial summary
The Goal of the study is to evaluate the rate of myopia progression with open ring myopia control spectacle lens designs compared to a commercial peripheral plus myopia control spectacle lens (CML) in European children with myopia. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia Progression
- How many people
- 180 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Apr 2026to Oct 2028
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Child
Study population: Children aged between 6-12 years old from Spain, Portugal and the United Kingdom
Who may be able to join
- Be aged between 6 to 12 completed years (6 and 12 years inclusive), irrespective of gender.
- For each group, an equal balance of gender will be recruited and 50% of children will be aged between 6- 9 years old and 50% aged 10-12 years old.
- Be cycloplegic autorefraction spherical component -0.50 D to -6.00D, cylinder no more than -2.00D, and with a spherical equivalent greater than or equal to -6.00D.
- Be accompanied by parents/guardians who can read and comprehend give informed consent as demonstrated by signing a record of informed consent.
- Be willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator.
- Have ocular health findings considered to be "normal".
- Be correctable to at least 6/9.5 (20/30) or better in each eye with spectacles.
- Be willing to wear the spectacles provided by the investigators for all waking hours.
Who cannot join
- A known allergy to, or a history of intolerance to cyclopentolate or topical anesthetics.
- Had strabismus and/or amblyopia.
- Cylinder more than -2.00D
- Anisometropia greater than 1.50D spherical equivalent
- Had previous eye surgery (including strabismus surgery).
- Any ocular, systemic or other condition or disease with possible associations with myopia or affecting refractive development e.g. Marfan syndrome, retinopathy of prematurity, diabetes.
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- Had any ocular injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids.
- Current orthoptic treatment or vision training.
- Any anatomical, skin or other condition that would impact on the wearing of spectacles.
- Use of or need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial.
- Currently enrolled in another clinical trial.
- No previous myopia management intervention or treatment.
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Portugal1 site
Universidade Do Minho
Braga
José Manuel Gonzalez Meijome, +351253604072, jgmeijome@fisica.uminho.pt
Spain1 site
Hospital Universitario Clínico San Carlos
Madrid
Noemi Güemes Villahoz, +34 (91)3303000, noemiguemes@gmail.com
United Kingdom1 site
Ulster University
Coleraine
Kathryn Sanders, +442870123456, kj.saunders@ulster.ac.uk
About this study
The Goal of the study is to evaluate the rate of myopia progression with open ring myopia control spectacle lens designs compared to a commercial peripheral plus myopia control spectacle lens (CML) in European children with myopia. This is a prospective, randomized, bilateral wear, double masked, cross-over clinical trial. There will be a total of 180 participants randomized into three groups, Group 1 - 60 participants will wear the commercial peripheral plus myopia control lens (CML).
Group 2 - 60 participants will wear the Open Ring 1 (OR1) lens design. Group 3 - 60 participants will wear the Open Ring 2 (OR2) lens design. For each group, an equal balance of gender will be recruited and 50% of children will be aged between 6- 9 years old and 50% aged 10-12 years old. All groups will be required to wear spectacles for all waking hours for 12 months. After 12 months, the control group will continue wearing CML for a further 12 months; the Group 2 participants will continue wearing the OR1 lens for a further 12 months. The Group 3 participants will wear OR2 or OR3 (a modified design of OR2) based on their risk of myopia progression for a further 12 months
- Conditions
- Myopia Progression
- Being tested
- myopia control lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myopia control lensOther
Evaluation of the efficacy in decreasing myopia progression of the proposed ophthalmic lens prototypes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Myopic progression in one year
This is expressed as the change in spherical equivalent refractive state from baseline levels. Spherical equivalent refraction will be taken as the mean of the spherical equivalent refraction of five, reliable, cycloplegic autorefraction measurements on each eye with a precision of 0.12D, measured in diopters (D). Myopia progression is also expressed as the change in axial length from baseline levels, measured in millimeters (mm). Myopia progression is characterized by ocular anatomical changes, the most notable being increased axial length, measured in millimeters (mm).
Measured: At baseline, 3, 6, 12, 18 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionOct 2028 (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 ProgressionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Indizen Optical Technologies, S.L.U.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital San Carlos, Madrid, University of Minho, University of Ulster
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394556
- Sponsor's protocol ID
- IOT-PRIME-2026-01
- Acronym
- PRIME
- Status last verified
- Mar 2026
- First submitted
- 30 Jan 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martinez-Perez C, Sanchez-Tena MA, Cleva JM, Villa-Collar C, Alvarez M, Chamorro E, Alvarez-Peregrina C. Efficacy of Asymmetric Myopic Peripheral Defocus Lenses in Spanish Children: 24-Month Randomized Clinical Trial Results. Children (Basel). 2025 Feb 6;12(2):191. doi: 10.3390/children12020191.
PubMed 40003293Sanchez-Tena MA, Cleva JM, Villa-Collar C, Alvarez M, Ruiz-Pomeda A, Martinez-Perez C, Andreu-Vazquez C, Chamorro E, Alvarez-Peregrina C. Effectiveness of a Spectacle Lens with a Specific Asymmetric Myopic Peripheral Defocus: 12-Month Results in a Spanish Population. Children (Basel). 2024 Feb 1;11(2):177. doi: 10.3390/children11020177.
PubMed 38397289
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Research on the Intervention of Myoless2.0 Effectiveness (PRIME) in Pediatric Population
- ClinicalTrials.gov ID
- NCT07394556
- Acronym / sponsor ID
- PRIME / IOT-PRIME-2026-01
- Conditions
- Myopia Progression
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Indizen Optical Technologies, S.L.U.Industry (pharma, biotech, devices)
- Collaborators
- Hospital San Carlos, Madrid, University of Minho, University of Ulster
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 6 Feb 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.
The Goal of the study is to evaluate the rate of myopia progression with open ring myopia control spectacle lens designs compared to a commercial peripheral plus myopia control spectacle lens (CML) in European children with myopia. This is a prospective, randomized, bilateral wear, double masked, cross-over clinical trial. There will be a total of 180 participants randomized into three groups, Group 1 - 60 participants will wear the commercial peripheral plus myopia control lens (CML).
Group 2 - 60 participants will wear the Open Ring 1 (OR1) lens design. Group 3 - 60 participants will wear the Open Ring 2 (OR2) lens design. For each group, an equal balance of gender will be recruited and 50% of children will be aged between 6- 9 years old and 50% aged 10-12 years old. All groups will be required to wear spectacles for all waking hours for 12 months. After 12 months, the control group will continue wearing CML for a further 12 months; the Group 2 participants will continue wearing the OR1 lens for a further 12 months. The Group 3 participants will wear OR2 or OR3 (a modified design of OR2) based on their risk of myopia progression for a further 12 months
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged between 6-12 years old from Spain, Portugal and the United Kingdom
Key inclusion criteria (8 listed)
- Be aged between 6 to 12 completed years (6 and 12 years inclusive), irrespective of gender.
- For each group, an equal balance of gender will be recruited and 50% of children will be aged between 6- 9 years old and 50% aged 10-12 years old.
- Be cycloplegic autorefraction spherical component -0.50 D to -6.00D, cylinder no more than -2.00D, and with a spherical equivalent greater than or equal to -6.00D.
- Be accompanied by parents/guardians who can read and comprehend give informed consent as demonstrated by signing a record of informed consent.
- Be willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator.
Key exclusion criteria (12 listed)
- A known allergy to, or a history of intolerance to cyclopentolate or topical anesthetics.
- Had strabismus and/or amblyopia.
- Cylinder more than -2.00D
- Anisometropia greater than 1.50D spherical equivalent
- Had previous eye surgery (including strabismus surgery).
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 |
|---|---|---|
| myopia control lensEvaluation of the efficacy in decreasing myopia progression of the proposed ophthalmic lens prototypes. | Other | – |
Primary outcome
Myopic progression in one year
Time frame: At baseline, 3, 6, 12, 18 and 24 months
This is expressed as the change in spherical equivalent refractive state from baseline levels. Spherical equivalent refraction will be taken as the mean of the spherical equivalent refraction of five, reliable, cycloplegic autorefraction measurements on each eye with a precision of 0.12D, measured in diopters (D). Myopia progression is also expressed as the change in axial length from baseline levels, measured in millimeters (mm). Myopia progression is characterized by ocular anatomical changes, the most notable being increased axial length, measured in millimeters (mm).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Background: PubMed 40003293Martinez-Perez C, Sanchez-Tena MA, Cleva JM, Villa-Collar C, Alvarez M, Chamorro E, Alvarez-Peregrina C. Efficacy of Asymmetric Myopic Peripheral Defocus Lenses in Spanish Children: 24-Month Randomized Clinical Trial Results. Children (Basel). 2025 Feb 6;12(2):191. doi: 10.3390/children12020191.
- Background: PubMed 38397289Sanchez-Tena MA, Cleva JM, Villa-Collar C, Alvarez M, Ruiz-Pomeda A, Martinez-Perez C, Andreu-Vazquez C, Chamorro E, Alvarez-Peregrina C. Effectiveness of a Spectacle Lens with a Specific Asymmetric Myopic Peripheral Defocus: 12-Month Results in a Spanish Population. Children (Basel). 2024 Feb 1;11(2):177. doi: 10.3390/children11020177.
- Individual participant dataSharing planned: No
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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.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia Progression, run by Indizen Optical Technologies, S.L.U. at 3 sites in 3 countries.
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 8 inclusion and 12 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: opening soon, as of the sponsor's last update on 5 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 3 sites in Portugal, Spain, United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eva Chamorro Guitierrez (+34(91) 8333786, evachamorro@iot.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myopic progression in one year (time frame: At baseline, 3, 6, 12, 18 and 24 months). 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 NCT07394556, 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 5 Mar 2026.