Clinical Evaluation of a Novel Spectacle Lens on Slowing Down Juvenile Myopia Progression

Not Applicable

Not yet recruiting

• Conditions: Myopia

• Registration Number: NCT06850168
• Lead Sponsor: Essilor International

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.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2025-02-24
• Study First Submitted QC: 2025-02-24
• Last Update Submitted: 2025-02-24
• Study First Posted: 2025-02-27
• Last Update Posted: 2025-02-27
• Study Start: 2025-05
• Primary Completion: 2027-09
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in Axial Length	24 months	To evaluate the effectiveness of the CABLE lens in slowing myopia progression with respect to the change in Axial Length (AL) from baseline compared to ORMA at 12-month. To evaluate the additive effect of CABLE lens in ocular growth by comparing the axial length change when CABLE design is added to Highly Aspherical Lenslet (HAL) lenses versus change in axial length with HAL lenses alone in year 2

Secondary Outcome Measures

Name	Time	Method
Change in Spherical Equivalent Refraction	24 months	To evaluate the effectiveness of the CABLE lens in slowing myopia progression with respect to the change in Spherical Equivalent Refraction (SER) from baseline compared to ORMA at 12-month. To evaluate the additive effect of CABLE lens on ocular refraction by comparing the change in spherical equivalent refraction when CABLE design is added to Highly Aspherical Lenslet (HAL) lenses versus change in spherical equivalent refraction with HAL lenses alone in year 2.