Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression (DAL)

Not Applicable

Active, not recruiting

• Conditions: Myopia
• Interventions: Device: Test myopia control lenses (DAL)

• Registration Number: NCT05840185
• Lead Sponsor: Essilor International

Brief Summary

This is a mono-centre, prospective, one-arm, unmask clinical trial to evaluate the effectiveness of test lens in slowing myopia progression with respect to axial length elongation compared to a single vision spectacle lens from the historical control group of another clinical trial NCT05331378. A total of 40 children will be recruited

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 (Bao et al. 2022). A dose-dependent effect was demonstrated, with higher lenslet asphericity having greater myopia control efficacy.

This open clinical trial 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 (40 subjects) at the time of commencing treatment. Axial length and spherical equivalent refraction will be the primary measure for myopia progression. Visual acuities will also be compared between test lenses and control lenses of the historical control group to determine the quality of vision using test lenses

Study Timeline

• Study First Submitted: 2023-04-21
• Study First Submitted QC: 2023-04-21
• Study First Posted: 2023-05-03
• Study Start: 2023-08-10
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-29
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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.
• 8 to 13 years old 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: Test myopia control lenses (DAL)	Test myopia control lenses (DAL)	A pair of myopia control spectacle lenses (test lenses) will be given to subjects 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
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