Clinical trial NCT06148870: Comparison of Efficacy Between Two Myopia Control Lenses
Official title: Comparison of Efficacy Between Two Myopia Control Lenses
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Myopia
Keywords: Refractive errors
Eye diseases
Axial length
Myopia Control
Lead sponsor: Essilor International
Sponsor class: INDUSTRY
First posted: 2023-11-28
Enrollment: 50
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 one-year, mono-centre, randomized, double-masked, monocular cross-over Clinical Trial with the objective to test and compare the efficacy of the new lens design in slowing down the increase of axial length and controlling myopic progression. The subject starts by wearing Myopia Control Lens 1 (MCL1) in one eye, and Myopia Control Lens 2 (MCL2) in another eye. After 6 months, a new pair of study spectacles will be dispensed with MCL1 and MCL2 crossed over. At the end of the 1-year period, each eye would have worn both MCL1 and MCL2 for 6 months each. There will be a total of 7 study visits with follow up periods at 3 months, 6 months and 12 months
Primary purpose: TREATMENT

Brief summary: This is a one-year, mono-centre, randomize, double-masked, monocular cross-over clinical trial designed to test and compare the efficacy of the new lens design in slowing down the increase of axial length and controlling myopia progression.

Detailed description: The clinical trial aims to assess the safety and efficacy of a test lens, designed to modify the amount of myopic control signal on the retina without compromising vision. 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:

* 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 6 years and not older than 11 years at time of informed consent and assent.
* Spherical equivalent refractive error (SER) by manifest refraction between -0.50 and -4.75 D in each eye.
* Astigmatism, if present, of not more than 2.00 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 better than +0.20 logMAR
* Agree to wear study spectacles for at least 10 hours a day and 6 days a week
* Willingness and ability to participate in trial for 1 year
* Willingness and ability to attend scheduled visits
* Not to involve concurrently in other myopia control treatments

Exclusion Criteria:

* History or presence of an Ocular disease, Strabismus, Amblyopia
* Undergoing any myopia control intervention specifically Atropine and Orthokeratology
* History of myopia control intervention specifically Atropine, Orthokeratology

Primary outcomes:
measure: Change in Axial Length
timeFrame: 12 months
Secondary outcomes:
measure: Change in Spherical Equivalent Refraction
timeFrame: 12 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Essilor R&D Centre Singapore
Study officials:
affiliation: Essilor R&D Centre Singapore
name: Wee Sing Ong
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11.
citation: Bao J, Huang Y, Li X, Yang A, Zhou F, Wu J, Wang C, Li Y, Lim EW, Spiegel DP, Drobe B, Chen H. Spectacle Lenses With Aspherical Lenslets for Myopia Control vs Single-Vision Spectacle Lenses: A Randomized Clinical Trial. JAMA Ophthalmol. 2022 May 1;140(5):472-478. doi: 10.1001/jamaophthalmol.2022.0401.
citation: Smith EL 3rd. Optical treatment strategies to slow myopia progression: effects of the visual extent of the optical treatment zone. Exp Eye Res. 2013 Sep;114:77-88. doi: 10.1016/j.exer.2012.11.019. Epub 2013 Jan 3.