- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05840185
Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression (DAL)
Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression - DAL
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Singapore, Singapore, 339346
- Essilor R&D Centre Singapore
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental: Test myopia control lenses (DAL)
A pair of myopia control spectacle lenses (test lenses) will be given to subjects to wear for 12 months
|
A pair of myopia control spectacle lenses (test lenses) will be given to subjects to wear for 12 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Axial Length
Time Frame: 12 months
|
Change in ocular axial length (mm) measured using Lenstar Optical Biometer.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spherical Equivalent Refraction
Time Frame: 6 months and 12 months
|
Change in spherical equivalent refraction (Dioptres) through manifest subjective refraction
|
6 months and 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wee Sing Ong, Essilor R&D Centre Singapore
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WS10315
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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