Comparison of Efficacy Between Two Myopia Control Lenses

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-29

Study Completion Date

2025-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

As this is a double-masked, randomized controlled trial, both the investigators and subjects will be masked.

Study Groups

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MCL1

The MCL1 is a myopia control lens that will be worn in one eye for 6 months.

Group Type ACTIVE_COMPARATOR

Myopia Control Lens-1 (MCL1)

Intervention Type DEVICE

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.

Myopia Control Lens-2 (MCL2)

Intervention Type DEVICE

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.

MCL2

The MCL2 is a myopia control lens that will be worn on the contralateral eye for 6 months.

Group Type EXPERIMENTAL

Myopia Control Lens-1 (MCL1)

Intervention Type DEVICE

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.

Myopia Control Lens-2 (MCL2)

Intervention Type DEVICE

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.

Interventions

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Myopia 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.

Intervention Type DEVICE

Myopia 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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes