Evaluate the Safety and Efficacy of Two Types of Circular Column Modulated Lenses for Delaying the Progression of Myopia
NCT ID: NCT05288335
Last Updated: 2022-12-28
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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UNKNOWN
NA
240 participants
INTERVENTIONAL
2022-05-01
2024-12-31
Brief Summary
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Detailed Description
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Primary outcome measure ocular axial length and the secondary indicator is spherical equivalent after cycloplegia.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Circular cylindrical mirror modulated frame glasses (compact)
Subjects that were randomized to receive the Circular cylindrical mirror modulated frame glasses (compact) throughout the entire course of the study.
Circular cylindrical mirror modulated frame glasses (compact)
Circular cylindrical mirror modulated frame glasses (compact)
Circular cylindrical mirror modulated frame glasses (strong defocus)
Subjects that were randomized to receive the Circular cylindrical mirror modulated frame glasses (strong defocus) throughout the entire course of the study.
Circular cylindrical mirror modulated frame glasses (strong defocus)
Circular cylindrical mirror modulated frame glasses (strong defocus)
single vision frame glasses
Subjects that were randomized to receive the single vision frame glasses throughout the entire course of the study.
single vision frame glasses
single vision frame glasses
Interventions
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Circular cylindrical mirror modulated frame glasses (compact)
Circular cylindrical mirror modulated frame glasses (compact)
Circular cylindrical mirror modulated frame glasses (strong defocus)
Circular cylindrical mirror modulated frame glasses (strong defocus)
single vision frame glasses
single vision frame glasses
Eligibility Criteria
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Inclusion Criteria
2. SER: -0.75 to -5.00 dioptres (D). Astigmatism and anisometropia of 1.50 D or less;
3. Monocular best corrected visual acuity (VA) of 1.0 or better;
4. Acceptance of random group allocation and the masked study design
5. Voluntarily participate in the clinical trial and sign the informed consent;
Exclusion Criteria
2. Ocular and systemic abnormalities.
3. Prior experience of myopia control.
6 Years
13 Years
ALL
Yes
Sponsors
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Tianjin Eye Hospital
OTHER
Responsible Party
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Principal Investigators
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Xiaoqin Chen, MD
Role: PRINCIPAL_INVESTIGATOR
Tianjin Eye Hospital
Locations
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Tianjin Eye Hospital
Tianjin, , China
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.
Muller J, Chen X, Ohlendorf A, Li L, Wahl S. Method comparison and overview of refractive measurements in children: implications for myopia management. BMJ Open Ophthalmol. 2024 Mar 1;9(1):e001322. doi: 10.1136/bmjophth-2023-001322.
Other Identifiers
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TianjinEH-myopia progression
Identifier Type: -
Identifier Source: org_study_id