ClinicalTrials.gg
RecruitingNCT07340931STELLARUpdated Jun 24, 2026

Pilot Study on the Adaptation and Tolerance of Essilor® Myopia-control Spectacle Lenses

An observational study in Myopia, sponsored by Nantes University Hospital. Recruiting at 1 site in France. Open to participants aged 6 Years to 16 Years. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by Nantes University Hospital · Observational

From the registry’s dates

  • Started Jan 2026; still recruiting 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
6 Years to 16 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 29 studies in Myopia with a site in France — 12 open to participants now, 13 under way, none of them phase 3. Myopia · France.

Started
2026
with 7 others
Observational
9 of 29
4 open now
Primary completion
2027-01
later than 1 of 12 live
Registered
25th of 29
by date
Lead sponsor
1 of 29
Nantes University Hospital

Among the 29 studies in Myopia with a site in France, this one is one of 8 that started in 2026, is one of 9 observational ones, reaches primary completion later than 1 of the 12 other live ones, and was the 25th registered.

Myopia

1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.

Browse Myopia studies →

Open to participants now

12 of the 29 studies in Myopia with a site in France are open now. Recruiting first, the newest first:

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All 12 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 122 Myopia studies recruiting now, 19 (16%) set no upper age limit and 102 (84%) stop at 75 or younger; 86 take children under 18; 53 take healthy volunteers.

This study: 6 Years to 16 Years · all sexes.

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02

Study 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 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.

03

Conditions studied

  • Myopia

Keywords

  • myopia
  • visual correction
  • compliance
04

Who can participate

Ages eligible
6 Years to 16 Years
Sexes eligible
All
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Patients with strabismus, amblyopia, or syndromic myopia
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • pediatric patient with Essilor® myopia-control spectacle lenses

    pediatric patient with Essilor® myopia-control spectacle lenses Stellet 2.0

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At 6 months after initiation of lens wear

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for Jan 2027, 12 months after the start.

Of 87 non-industry observational studies under Myopia, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 90. This study's planned 12 months is below that.

Counting every sponsor, half of 96 studies reached it within 24 months; a quarter within 10 and three quarters within 59.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 6, 2026
First posted
Jan 14, 2026
StartActual
Jan 20, 2026
Primary completionEst.
Jan 20, 2027
CompletionEst.
Jan 20, 2027
Last update
Jun 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07340931
Responsible party
Sponsor
First posted
Jan 14, 2026
Start date
Jan 20, 2026
Primary completion
Jan 20, 2027 (estimated)
Completion
Jan 20, 2027 (estimated)
Last update
Jun 24, 2026

Study contacts

Pierre Lebranchu, MD PhD
Contact
pierre.lebranchu@chu-nantes.fr
+33 2 53 48 28 57
Alexandra Poinas, PhD
Contact
alexandra.poinas@chu-nantes.fr
+ 33 2 53 48 28 57

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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