MyopiaPEARLNCT07839091
Comparing Myopia Control Spectacle Lenses and Standard Single Vision Spectacle Lenses in Children With Myopia
A study testing Single Vision Spectacle Lens in people with Myopia and Myopia Progression, run by Essilor International at 1 site in Singapore.
Trial summary
The purpose of this clinical trial is to compare a new myopia control spectacle lens with a standard single vision spectacle lens in slowing the progression of myopia (nearsightedness) in healthy children aged 6 to under 11 years. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Myopia, Myopia Progression
- What is being tested?
- Single Vision Spectacle Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- Oct 2026to Jul 2028
- Phase
- Interventional
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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Volunteer participant with the willingness and ability to comply with all scheduled study visits.
- Informed consent of parent/guardian and assent of participant.
- Age equal to or greater than 6 years and less than 11 years (before 11th birthday) at the time of consent.
- Spherical equivalent refraction (SER) equal or less than -0.50 D and equal or greater than -4.75D with astigmatism not more than 2.00 D.
- Difference in SER (anisometropia) between two eyes should not exceed 1.00 D.
- Best corrected Distance Visual Acuity (BCDVA) better than or equal to +0.10 LogMAR under high contrast in each eye.
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- Be in good general health, based on the participant and the parent's/guardian's knowledge.
- Agree to wear the study spectacles for 12 hours per day and 7 days per week.
- Agree not to be involved in other myopia control treatments.
Who cannot join
- History of Atropine, Orthokeratology, Myopia Control Contact Lens, or Red Light treatment.
- Strabismus by cover test at near or distance wearing correction.
- History and presence of amblyopia.
- Any ocular or systemic condition known to affect refractive status (e.g. keratoconus, diabetes, Downs syndrome, or other developmental disorders, etc.).
- Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
- History of ocular injury or surgery.
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- Participation in any clinical study within 30 days of the Baseline visit.
- Current or anticipated use of growth hormones.
- Study participants deemed inappropriate for the study by the investigator.
- The inherent ocular/systemic discomfort (dry eyes, visual fatigue, headaches, etc.) that may affect the evaluation of the study lens wearing experience, from the investigator's perspective.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thomas Boudenne contact
Singapore1 site
Essilor R&D Centre Singapore
Singapore
Celine Carimalo, 67134617 ext. +65, carimalc@essilor.com.sg
About this study
Official title: A Paired-Eye Comparison of Myopia Control Lenses in Myopic Children
The purpose of this clinical trial is to compare a new myopia control spectacle lens with a standard single vision spectacle lens in slowing the progression of myopia (nearsightedness) in healthy children aged 6 to under 11 years.
The main question being studied is:
Read more
Is the new myopia control spectacle lens more effective than a standard single vision spectacle lens in slowing myopia progression?
In this study, participants will wear a myopia control spectacle lens in one eye and a standard single vision spectacle lens in the other eye for the first 6 months. The lens assignment will then be switched between eyes for the remaining 6 months. Researchers will compare changes in eye axial length and refractive error between the two lens types.
Participants will:
- Wear the study spectacles for 12 months.
- Attend scheduled follow-up visits at the Essilor R\&D Centre, Singapore.
- Conditions
- Myopia, Myopia Progression
- Being tested
- Investigational Myopia Control Spectacle Lens, Single Vision Spectacle Lens
- Keywords
- refractive error, myopia control, axial length
- Medical subject headings
- Myopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Myopia Control Spectacle LensDevice
A spectacle lens designed to help slow the progression of myopia in children
Single Vision Spectacle LensDevice
A standard spectacle lens used to correct refractive error without a specific myopia control feature
| Study group | Role | What they receive |
|---|---|---|
| OD: SVL; OS: MCL then OD: MCL; OS: SVL | Experimental | Participants will wear the investigational myopia control spectacle lens in the left eye and a standard single vision spectacle lens in the right eye for the first 6 months. After 6 months, the lens assignment will be switched, with each eye wearing the opposite lens type for another 6 months. Receives: Device: Investigational Myopia Control Spectacle Lens; Device: Single Vision Spectacle Lens |
| OD: MCL; OS: SVL then OD: SVL; OS: MCL | Experimental | Participants will wear the investigational myopia control spectacle lens in the right eye and a standard single vision spectacle lens in the left eye for the first 6 months. After 6 months, the lens assignment will be switched, with each eye wearing the opposite lens type for another 6 months. Receives: Device: Investigational Myopia Control Spectacle Lens; Device: Single Vision Spectacle Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Eye Axial Length
Measured: From baseline to 6 months
Secondary outcomes (3)
Change in Eye Axial Length
Measured: From 6 months to 12 months
Change in Eye Non-Cycloplegic Spherical Equivalent Refraction
Measured: From baseline to 6 months
Change in Eye Non-Cycloplegic Spherical Equivalent Refraction
Measured: From 6 months to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionJul 2028 (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.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Essilor International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Tan, Principal investigator, Essilor R&D Centre Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839091
- Sponsor's protocol ID
- WS10528
- Acronym
- PEARL
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No