MyopiaSTELLARNCT07340931
Pilot Study on the Adaptation and Tolerance of Essilor® Myopia-control Spectacle Lenses
An observational study of Myopia, run by Nantes University Hospital at 1 site in France.
Trial summary
This observational pilot study aims to evaluate the adaptation and tolerance of Essilor® Stellest® myopia-control spectacle lenses in children with progressive myopia. The objective is to assess real-life compliance and comfort during lens wear, as these factors are essential for long-term therapeutic adherence and… Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Myopia
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jan 2026to 20 Jan 2027
- 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 16 years
- All sexes
- Child
Study population: Children and adolescents with myopia followed at the Ophthalmology Departments of Nantes University Hospital and Strasbourg University Hospital, as well as at the Centre Ophtalmologique de l'Hippodrome in Lambersart.
Who may be able to join
- Patients aged 6 to 16 years with progressive myopia.
- Spherical equivalent ≤ -0.50 D under cycloplegia and presence of at least one risk factor (age < 10 years, progression ≥ 0.50 D/year, axial length increase ≥ 0.2 mm/year, high myopia ≤ -6.00 D and/or axial length ≥ 26 mm, both parents myopic, at least one parent highly myopic, or Asian origin).
- Patient covered by the French social security system.
- Patient and legal guardians providing oral non-opposition to participate in the study.
Who cannot join
- Patients with strabismus, amblyopia, or syndromic myopia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Nantes - Ophthalmology Department
Nantes, Nantes, 44000
Alexandra Poinas, +33 2 40 08 33 33, alexandra.poinas@chu-nantes.fr
About this study
This observational pilot study aims to evaluate the adaptation and tolerance of Essilor® Stellest® myopia-control spectacle lenses in children with progressive myopia. The objective is to assess real-life compliance and comfort during lens wear, as these factors are essential for long-term therapeutic adherence and overall visual health outcomes
Read the detailed description
Myopia is a refractive error in which light rays from distant objects focus in front of the retina, resulting in blurred distance vision. It is most commonly caused by an elongation of the axial length of the eye. Myopia has become a major public health issue of the 21st century, with estimates suggesting that nearly 50% of the global population will be myopic by 2050. High myopia significantly increases the risk of serious ocular complications, including glaucoma, early cataract, myopic maculopathy, retinal tears, and detachments. Myopia typically begins in childhood and tends to appear earlier and progress faster than in previous generations, with onset now occurring around 6-7 years of age instead of 12-13. Early detection and appropriate optical correction can have a substantial impact on a child's academic performance and quality of life, as good vision is closely linked to both. Progressive myopia, a form that worsens over time, requires active management to slow or halt its progression and prevent high myopia. Among available approaches, optical devices such as Essilor® Stellest® lenses have shown promise in myopia control. However, their real-world effectiveness depends not only on optical performance but also on the child's ability to adapt to and tolerate the lenses, which directly influences daily wear time and long-term compliance. This observational study therefore focuses on evaluating the adaptation and tolerance of Essilor® Stellest® lenses prescribed to children with progressive myopia in routine clinical practice.
- Conditions
- Myopia
- Keywords
- myopia, visual correction, compliance
- Medical subject headings
- Myopia, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pediatric patient with Essilor® myopia-control spectacle lenses | pediatric patient with Essilor® myopia-control spectacle lenses Stellet 2.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adaptation and tolerance of Essilor® Stellest® 2.0 myopia-control spectacle lenses
Evaluation of the adaptation and tolerance of Essilor® Stellest® 2.0 lenses in children with progressive myopia, using the PREP-2 quality-of-life questionnaire (56 items) to assess comfort, visual satisfaction, and overall acceptance after regular use.
Measured: At 6 months after initiation of lens wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start20 Jan 2026
- Primary completion20 Jan 2027 (estimated)
- Study completion20 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07340931
- Sponsor's protocol ID
- AP_PL_Stellar
- Acronym
- STELLAR
- Status last verified
- Jun 2026
- First submitted
- 6 Jan 2026
- Last updated
- 24 Jun 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 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Adaptation and Tolerance of Essilor® Myopia-control Spectacle Lenses
- ClinicalTrials.gov ID
- NCT07340931
- Acronym / sponsor ID
- STELLAR / AP_PL_Stellar
- Conditions
- Myopia
- Keywords
- myopia, visual correction, compliance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 20 Jan 2027 (estimated)
- Study completion
- 20 Jan 2027 (estimated)
- First posted
- 14 Jan 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 observational pilot study aims to evaluate the adaptation and tolerance of Essilor® Stellest® myopia-control spectacle lenses in children with progressive myopia. The objective is to assess real-life compliance and comfort during lens wear, as these factors are essential for long-term therapeutic adherence and overall visual health outcomes
Detailed description
Myopia is a refractive error in which light rays from distant objects focus in front of the retina, resulting in blurred distance vision. It is most commonly caused by an elongation of the axial length of the eye. Myopia has become a major public health issue of the 21st century, with estimates suggesting that nearly 50% of the global population will be myopic by 2050. High myopia significantly increases the risk of serious ocular complications, including glaucoma, early cataract, myopic maculopathy, retinal tears, and detachments. Myopia typically begins in childhood and tends to appear earlier and progress faster than in previous generations, with onset now occurring around 6-7 years of age instead of 12-13. Early detection and appropriate optical correction can have a substantial impact on a child's academic performance and quality of life, as good vision is closely linked to both. Progressive myopia, a form that worsens over time, requires active management to slow or halt its progression and prevent high myopia. Among available approaches, optical devices such as Essilor® Stellest® lenses have shown promise in myopia control. However, their real-world effectiveness depends not only on optical performance but also on the child's ability to adapt to and tolerate the lenses, which directly influences daily wear time and long-term compliance. This observational study therefore focuses on evaluating the adaptation and tolerance of Essilor® Stellest® lenses prescribed to children with progressive myopia in routine clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pediatric patient with Essilor® myopia-control spectacle lenses | – | –pediatric patient with Essilor® myopia-control spectacle lenses Stellet 2.0 |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- Children and adolescents with myopia followed at the Ophthalmology Departments of Nantes University Hospital and Strasbourg University Hospital, as well as at the Centre Ophtalmologique de l'Hippodrome in Lambersart.
Key inclusion criteria (4 listed)
- Patients aged 6 to 16 years with progressive myopia.
- Spherical equivalent ≤ -0.50 D under cycloplegia and presence of at least one risk factor (age < 10 years, progression ≥ 0.50 D/year, axial length increase ≥ 0.2 mm/year, high myopia ≤ -6.00 D and/or axial length ≥ 26 mm, both parents myopic, at least one parent highly myopic, or Asian origin).
- Patient covered by the French social security system.
- Patient and legal guardians providing oral non-opposition to participate in the study.
Key exclusion criteria (1 listed)
- Patients with strabismus, amblyopia, or syndromic myopia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adaptation and tolerance of Essilor® Stellest® 2.0 myopia-control spectacle lenses
Time frame: At 6 months after initiation of lens wear
Evaluation of the adaptation and tolerance of Essilor® Stellest® 2.0 lenses in children with progressive myopia, using the PREP-2 quality-of-life questionnaire (56 items) to assess comfort, visual satisfaction, and overall acceptance after regular use.
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 24 Jun 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia, run by Nantes University Hospital at 1 site in France.
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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 24 Jun 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 France. 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 Pierre Lebranchu, MD PhD (+33 2 53 48 28 57, pierre.lebranchu@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adaptation and tolerance of Essilor® Stellest® 2.0 myopia-control spectacle lenses (time frame: At 6 months after initiation of lens wear). 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 24 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.