Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression

Not Applicable

Active, not recruiting

• Conditions: Myopia, Progressive; Myopia
• Interventions: Device: Single vision lenses; Device: Test myopia control lenses

• Registration Number: NCT05331378
• Lead Sponsor: Essilor International

Brief Summary

This is a monocenter, randomized, controlled, parallel-group, double-masked clinical trial to evaluate the effectiveness of test lens in slowing myopia progression with respect to axial length elongation at baseline compared to a single vision spectacle lens (control). A total of 80 children will be recruited where 40 subjects will be allocated either to wear test lenses (group 1) or control lenses (group 2) for 1 year through randomization.

Detailed Description

As myopia is a growing worldwide problem, it is important to better understand the range of possible treatments to slow the progression of myopia. Spectacle lenses with aspherical lenslets were shown to be effective in reducing myopia progression and axial length elongation in children in the previous clinical trial. A dose-dependent effect was demonstrated, with higher lenslet asphericity having greater myopia control efficacy.

This double masked parallel group study will test the safety and effectiveness of a test lens designed to modify the area and amount of myopic defocus on the retina without compromising vision. The study population includes children in Singapore aged 8 to 13 years (80 subjects) at the time of commencing treatment. As age of myopia onset is known to be an important factor in rate of myopia progression, subject age at the time of enrollment will be used to balance randomization. Axial length and spherical equivalent refraction will be the primary measure for myopia progression. Visual acuity will also be compared between test lenses and control lenses to determine the quality of vision using test lenses.

Study Timeline

• Study First Submitted: 2022-04-08
• Study First Submitted QC: 2022-04-08
• Study First Posted: 2022-04-15
• Study Start: 2022-04-25
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-28
• Primary Completion: 2024-10
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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 8 years and not older than 13 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.
• History of myopia control intervention
• 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
• Participation in any clinical study within 30 days of the Baseline visit.
• Sibling of existing participant of this study

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single vision lenses	Single vision lenses	A single vision spectacle lenses (control lenses) will be given to 1 arm to wear for 12 months.
Test myopia control lenses	Test myopia control lenses	A myopia control spectacle lenses (test lenses) will be given to 1 arm to wear for 12 months.

Primary Outcome Measures

Name	Time	Method
Axial Length	12 months	Change in ocular axial length (mm) measured using Lenstar Optical Biometer.

Secondary Outcome Measures

Name	Time	Method
Carry-over Effect	18 months and 24 months	Change in ocular axial length (mm) measured using Lenstar Optical Biometer after switching to STELLEST™ lenses
Axial Length	6 months	Change in ocular axial length (mm) measured using Lenstar Optical Biometer.
Spherical Equivalent Refraction	6 months and 12 months	Change in spherical equivalent refraction (Dioptres) through manifest subjective refraction.

Trial Locations

Locations (1)

Essilor R&D Centre Singapore; 🇸🇬 Singapore, Singapore