Clinical trial NCT06850168: Clinical Evaluation of a Novel Spectacle Lens on Slowing Down Juvenile Myopia Progression
Official title: Clinical Evaluation of a Novel Spectacle Lens on Slowing Down Juvenile Myopia Progression
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Myopia
Keywords: Refractive error
Eye disease
Axial length
Myopia control
Lead sponsor: Essilor International
Sponsor class: INDUSTRY
First posted: 2025-02-27
Enrollment: 35
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a 2-years, mono-centre, randomized, double-masked, monocular exploratory clinical trial with the objective to test and compare the efficacy of the test lens in slowing down the increase of axial length and controlling myopic progression. The subject starts by wearing CABLE in one eye, and reference lens in another eye. After 1 year, a new pair of study spectacles will be dispensed with CABLE changed to HAL, and reference lens changed to HAL + CABLE design. At the end of the 2-years period, each eye would have exposed to CABLE design for 1 year each. There will be a total of 11 study visits with follow up periods at 6 months,12 months, 18 months and 24 months.
Primary purpose: TREATMENT

Brief summary: This study will be a 2 year, double-masked, randomized, controlled mono-center monocular exploratory clinical investigation to test and compare the efficacy of the test lens in slowing down the increase of axial length and controlling myopia progression.

Detailed description: The clinical trial aims to assess the efficacy and safety of a test lens, designed to emit red-light when exposed to natural daylight that can produce a cumulative red-light exposure equivalent to the sham device (Dong et. al, 2023) when children spend about 30 minutes in a day. The primary goal of this clinical trial is to evaluate the effectiveness of the test lens in slowing down the increase of axial length and controlling myopia progression compared to the reference lens design.

Eligibility criteria: Inclusion Criteria:

* Children equal to or greater than 6 years old and less than 11 years at the time of signing informed consent.
* Corrected spherical equivalent refraction (SER) between -0.75 D and -5.00 D with astigmatism not more than 2.50 D.
* Difference in SER (Anisometropia) between two eyes should not exceed 1.00 D.
* Best corrected visual acuity better than or equal to +0.10 log MAR (20/25 or better with Snellen).
* Be in good general health, based on his/her and parent's/guardian's knowledge.
* Agree to wear spectacles for \>12 hours/day and at least 6 days/week.
* Willingness and ability to participate in investigation for 2 years and attend scheduled visits.

Exclusion Criteria:

* Any ocular or systemic pathologies known to affect refractive status (e.g. keratoconus, diabetes, Down's syndrome etc.)
* Any binocular vision anomalies
* Amblyopia
* Use of prior myopia control treatment like specialized myopia control spectacles and contact lenses at least in the previous one month.
* Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
* Participation in any clinical investigation within 30 days of the baseline visit.

Primary outcomes:
measure: Change in Axial Length
timeFrame: 24 months
Secondary outcomes:
measure: Change in Spherical Equivalent Refraction
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Essilor R&D Centre Singapore
name: Andrew Tan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jiang Y, Zhu Z, Tan X, Kong X, Zhong H, Zhang J, Xiong R, Yuan Y, Zeng J, Morgan IG, He M. Effect of Repeated Low-Level Red-Light Therapy for Myopia Control in Children: A Multicenter Randomized Controlled Trial. Ophthalmology. 2022 May;129(5):509-519. doi: 10.1016/j.ophtha.2021.11.023. Epub 2021 Dec 1.
citation: Dong J, Zhu Z, Xu H, He M. Myopia Control Effect of Repeated Low-Level Red-Light Therapy in Chinese Children: A Randomized, Double-Blind, Controlled Clinical Trial. Ophthalmology. 2023 Feb;130(2):198-204. doi: 10.1016/j.ophtha.2022.08.024. Epub 2022 Aug 29.