Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression.

Myopia Clinical Trial

Official title:

Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression - Open Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05534022
• Other study ID #: WS10273
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 26, 2022
• Est. completion date: November 2024

Study information

• Verified date: February 2023
• Source: Essilor International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 13 Years

Eligibility

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.

• 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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Test myopia control lenses (BSL)
Myopia control spectacle lenses (test lenses) will be given to subjects throughout the 24 months trial.

Locations

Country	Name	City	State
Singapore	Essilor R&D Centre Singapore	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Essilor International

Country where clinical trial is conducted

Singapore, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axial Length	Change in ocular axial length (mm)	12 months and 24 months
Secondary	Axial Length	Change in ocular axial length (mm)	6 months and 18 months
Secondary	Spherical Equivalent Refraction	Change in spherical equivalent refraction (Dioptres) through manifest subjective refraction.	6 months, 12 months, 18 months and 24 months