An interventional study of Lenslet-based myopia control spectacle lens in Astigmatism and Myopia, sponsored by Essilor International. Not yet recruiting. Open to participants aged 6 Years to 13 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Essilor International · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to investigate over a one-year period the effect of myopia control spectacle lenses on astigmatism in children aged 6 to 13 years with myopia and astigmatism.
The main question it aims to answer is:
- How does the eye respond at each timepoint to the myopia control lenses?
By evaluating: the change in astigmatism (cylinder) after one year?
Participants will:
Wear the assigned study spectacles daily
Visit the Essilor R\&D Centre for scheduled follow-up sessions
417 studies on the registry are indexed under Astigmatism; 50 are open to participants now.
This study's planned enrollment of 15 is below the median of 55 across 325 interventional studies indexed under Astigmatism.
Browse Astigmatism studies →Essilor International is the lead sponsor of 38 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Refractive error (manifest refraction):
Willingness and ability to:
Exclusion Criteria:
History or presence of:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Each participant will be fitted with a prototype lenslet-based spectacle lens to be worn continuously throughout the 12-month study period. Following the baseline and dispensing visit, participants will undergo follow-up assessments at 3, 6, and 12 months. These intervals will monitor change of myopia and astigmatism through standard refraction and ocular biometry measurements. Device Details: The myopia control spectacle lens utilized in this study features a lenslet-based design (incorporating a highly aspherical lenslet configuration). The lenses will be dispensed and worn daily for the duration of the 12-month evaluation period.
Device: Lenslet-based myopia control spectacle lens
Device Details: The myopia control spectacle lens utilized in this study features a lenslet-based design (incorporating a highly aspherical lenslet configuration). In this specific device, the lenslet are located in concentric rings.
Change from baseline in the Cylinder value through non cycloplegic autorefraction
Time frame: 12 months
Change from baseline in the Keratometry value measured using a Keratometer
Time frame: 12 months
Change from baseline in the Axial Length value measured using a biometer
Time frame: 12 months
Quality of Life while wearing the study lenses measured through Questionnaire
PREP 2 questionnaire: Pediatric Refractive Error Profile 2 The questionnaire is designed to assess the vision-specific quality of life in children who wear glasses or contact lenses. It covers seven areas: Vision, Symptoms, Handling, Peer Perception, Activities, Appearance, and Overall. The Child form is a 5 point agreement scale ranging from: Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree The parent form is a 10 point agreement scale ranging from 1=likes and 10=dislikes
Time frame: Baseline, 6 and 12 months
Safety: Change from baseline in the Axial Length value measured using a biometer
Time frame: 3 and 6 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Feb 2028, 17 months later.
Of 106 industry-sponsored interventional studies with no phase under Astigmatism, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 19. This study's planned 17 months is above that.
Counting every sponsor, half of 183 studies reached it within 12 months; a quarter within 4 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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