Clinical trial NCT06857864: Exploratory Study on the Effectiveness of Myopia Control Lenses in Slowing Myopia Progression in Young Children
Official title: Exploratory Study on the Effectiveness of Myopia Control Lenses in Slowing Myopia Progression in Young Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia
Keywords: Myopia
Refractive errors
Eye Diseases
Lead sponsor: Essilor International
Sponsor class: INDUSTRY
First posted: 2025-03-04
Enrollment: 25
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a mono-center, single-arm, unmasked study consisting of 6 visits over 1 year. This study aims to evaluate the change in axial elongation and spherical equivalent refraction in younger children who are fitted with the test lenses over a 1-year period.

After obtaining informed consent and assent, a comprehensive eye examination will be conducted during the screening visit on all participants. Eligible participants, total of 25, between ages 6 to 8 years old will be enrolled into the study. On a separate visit, the enrolled subjects will return for a baseline visit to collect the study spectacles. During the baseline visit, instructions on study spectacles usage, assessment with study spectacles and ocular biometry will be conducted. Follow-up visits will be conducted at 3, 6 and 12 months' time, where 12 months is the end of study.

All eye examinations and assessments are non-contact and non-invasive to the eyes.
Primary purpose: TREATMENT

Brief summary: This study will be a mono-center, single-arm, unmasked study evaluating the effectiveness of test lens in slowing myopia progression in children aged 6 to 8 years. The study aims to evaluate the change in axial elongation and spherical equivalent refraction in younger children who are fitted with the test lens over a 1-year period. A total of 25 children will be recruited.

Detailed description: As myopia has become a global epidemic and public health concern, it is crucial to gain deeper insight to the possible treatments in slowing myopia progression. In a previous clinical trial, spectacle lenses with higher lenlets asphericity demonstrated effectiveness in reducing myopia progression and axial length elongation in children.

This clinical trial will assess the effectiveness of a test lens in slowing myopia progression in younger children over 1 year. Without compromising vision, the test lens is designed to modify the area and the amount of myopia defocus on the retina. The study population includes 25 children subjects in Singapore, aged 6 to 8 years during the commencement of the treatment. The axial length and spherical equivalent refraction will be the primary and secondary measures for myopia progression.

Eligibility criteria: Inclusion Criteria:

* Volunteer subject and guardian, fluent English spoken, willing to follow protocol and able to read, comprehend and sign the informed consent \& assent form.
* Equal to or greater than 6 years and less than 9 years at time of informed consent and assent.
* Spherical equivalent refractive error (SER) by manifest refraction between -0.75 and -4.75 D in each eye.
* Astigmatism, if present, of not more than 1.50 D.
* Difference in SER between the two eyes (Anisometropia) by manifest refraction not more than 1.00 D.
* Best corrected visual acuity in each eye equal to or better than +0.10 logMAR (≥ 20/25 as Snellen)
* Be in good general health based on his/her and parent's/guardian's knowledge. Absence of ocular disease with full ophthalmic examination. Without any ocular or systemic condition known to affect refractive status.
* Absence of strabismus by cover test at near or distance wearing correction.
* Absence of amblyopia
* Without ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.

Exclusion Criteria:

* Vulnerability of subject
* History of myopia control intervention
* Participation in any clinical study within 30 days of the Baseline visit.

Primary outcomes:
measure: Axial length
timeFrame: 12 months
Secondary outcomes:
measure: Axial length
timeFrame: 6 months
measure: Spherical Equivalent Refraction
timeFrame: 6 months, 12 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Essilor R&D Centre
Study officials:
References:
citation: Bao J, Yang A, Huang Y, Li X, Pan Y, Ding C, Lim EW, Zheng J, Spiegel DP, Drobe B, Lu F, Chen H. One-year myopia control efficacy of spectacle lenses with aspherical lenslets. Br J Ophthalmol. 2022 Aug;106(8):1171-1176. doi: 10.1136/bjophthalmol-2020-318367. Epub 2021 Apr 2.