Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression (DAL)
NCT ID: NCT05840185
Last Updated: 2023-11-29
Study Results
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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ACTIVE_NOT_RECRUITING
NA
40 participants
INTERVENTIONAL
2023-08-10
2024-08-31
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
After obtaining informed consent and assent, a comprehensive eye examination will be conducted during the screening visit on all 40 myopic children between the age of 8 to 13 years old. Eligible children will return in a separate visit (baseline visit) to collect the study spectacles and the assessment of study spectacles, biometry and instructions to use study spectacles are established in the same visit. A follow up visit will be conducted in 3, 6 and 12 months time, where 12 months is the end of study. All of the eye examinations and assessments are non-contact and non-invasive to the eyes.
TREATMENT
NONE
Study Groups
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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
Test myopia control lenses (DAL)
A pair of myopia control spectacle lenses (test lenses) will be given to subjects to wear for 12 months
Interventions
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Test myopia control lenses (DAL)
A pair of myopia control spectacle lenses (test lenses) will be given to subjects to wear for 12 months
Eligibility Criteria
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Inclusion Criteria
* 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
* History of myopia control intervention
* Participation in any clinical study within 30 days of the Baseline visit.
8 Years
13 Years
ALL
Yes
Sponsors
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Essilor International
INDUSTRY
Responsible Party
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Principal Investigators
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Wee Sing Ong
Role: PRINCIPAL_INVESTIGATOR
Essilor R&D Centre Singapore
Locations
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Essilor R&D Centre Singapore
Singapore, , Singapore
Countries
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References
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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.
Other Identifiers
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WS10315
Identifier Type: -
Identifier Source: org_study_id