Comparing Myopia Control Spectacle Lenses and Standard Single Vision Spectacle Lenses in Children With Myopia

NCT07839091 — Not applicable, Not yet recruiting, 20 participants, Essilor International

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A Paired-Eye Comparison of Myopia Control Lenses in Myopic Children

Registry	NCT07839091, acronym PEARL
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: none, treatment
Enrollment	20 (Estimated)
Sponsor	Essilor International (Industry)
Conditions	Myopia, Myopia Progression
Interventions	Investigational Myopia Control Spectacle Lens, Single Vision Spectacle Lens (Device)
Dates	start 2026-10-01 (estimated), primary completion 2028-03-01 (estimated), completion 2028-07-01 (estimated), first posted 2026-09-24, last updated 2026-09-24
Locations	1 site in Singapore

-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.

The main question being studied is:

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.

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+Arms and interventions

Arm	Type	Interventions	Description
OD: SVL; OS: MCL then OD: MCL; OS: SVL	Experimental	Device: Investigational Myopia Control Spectacle Lens; Device: Single Vision Spectacle Lens	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.
OD: MCL; OS: SVL then OD: SVL; OS: MCL	Experimental	Device: Investigational Myopia Control Spectacle Lens; Device: Single Vision Spectacle Lens	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.

Investigational Myopia Control Spectacle Lens (Device): A spectacle lens designed to help slow the progression of myopia in children
Single Vision Spectacle Lens (Device): A standard spectacle lens used to correct refractive error without a specific myopia control feature

+Outcome measures

Primary outcomes

Change in Eye Axial Length [From baseline to 6 months]

Secondary outcomes

Change in Eye Axial Length [From 6 months to 12 months]
Change in Eye Non-Cycloplegic Spherical Equivalent Refraction [From baseline to 6 months]
Change in Eye Non-Cycloplegic Spherical Equivalent Refraction [From 6 months to 12 months]

+Eligibility

Sex: All, ages: 6 Years to 10 Years

Inclusion Criteria:

1. Volunteer participant with the willingness and ability to comply with all scheduled study visits.
2. Informed consent of parent/guardian and assent of participant.
3. Age equal to or greater than 6 years and less than 11 years (before 11th birthday) at the time of consent.
4. 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.
5. Difference in SER (anisometropia) between two eyes should not exceed 1.00 D.
6. Best corrected Distance Visual Acuity (BCDVA) better than or equal to +0.10 LogMAR under high contrast in each eye.
7. Be in good general health, based on the participant and the parent's/guardian's knowledge.
8. Agree to wear the study spectacles for 12 hours per day and 7 days per week.
9. Agree not to be involved in other myopia control treatments.

Exclusion Criteria:

1. History of Atropine, Orthokeratology, Myopia Control Contact Lens, or Red Light treatment.
2. Strabismus by cover test at near or distance wearing correction.
3. History and presence of amblyopia.
4. Any ocular or systemic condition known to affect refractive status (e.g. keratoconus, diabetes, Downs syndrome, or other developmental disorders, etc.).
5. Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
6. History of ocular injury or surgery.
7. Participation in any clinical study within 30 days of the Baseline visit.
8. Current or anticipated use of growth hormones.
9. Study participants deemed inappropriate for the study by the investigator.
10. 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.

+Locations (1)

Facility	City	Country	Status
Essilor R&D Centre Singapore	Singapore	Singapore

+Investigators

Andrew Tan, Principal investigator, Essilor R&D Centre Singapore