Myopia
Conditions
Keywords
Refractive errors, Eye diseases, Axial length, Myopia Control
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.
Interventions
DEVICEMyopia Control Lens-1 (MCL1)
The MCL1, is a myopia control lens that corrects refractive error and simultaneously creates myopia control signals. It will be worn on one eye for 6 months.
DEVICEMyopia Control Lens-2 (MCL2)
The MCL2, is a myopia control lens that corrects refractive error and simultaneously creates myopia control signals. It will be worn on the contralateral eye for 6 months.
Sponsors
Essilor International
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
As this is a double-masked, randomized controlled trial, both the investigators and subjects will be masked.
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
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Axial Length | 12 months | To evaluate the effectiveness of the MCL2 in slowing myopia progression with respect to the change in Axial Length (AL) from baseline compared to MCL1 at 12-month. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Spherical Equivalent Refraction | 12 months | To evaluate the effectiveness of the MCL2 lens in slowing myopia progression with respect to the change in Spherical Equivalent Refraction (SER) from baseline compared to MCL1 at 12-month. |
Countries
Singapore
Contacts
PRINCIPAL_INVESTIGATORWee Sing Ong
Essilor R&D Centre Singapore
Outcome results
None listed