Evaluate the Safety and Efficacy of Two Types of Circular Column Modulated Lenses for Delaying the Progression of Myopia
Muti-center Clinical Trial to Evaluate the Safety and Efficacy of Two Types of Circular Column Modulated Lenses for Delaying the Progression of Myopia
1 other identifier
interventional
240
1 country
1
Brief Summary
Clinical trial to evaluate the safety and effectiveness of two kinds of ring band cylindrical lens in delaying the progression of myopia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2022
CompletedFirst Posted
Study publicly available on registry
March 21, 2022
CompletedStudy Start
First participant enrolled
May 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedDecember 28, 2022
January 1, 2022
1.5 years
February 10, 2022
December 25, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in ocular axial length in a year
The ocular axial length was measured by AL-scan
baseline, 12 months
Secondary Outcomes (1)
Changes in cycloplegic objective spherical equivalent in a year
baseline, 12 months
Study Arms (3)
Circular cylindrical mirror modulated frame glasses (compact)
EXPERIMENTALSubjects 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 (strong defocus)
EXPERIMENTALSubjects that were randomized to receive the Circular cylindrical mirror modulated frame glasses (strong defocus) throughout the entire course of the study.
single vision frame glasses
EXPERIMENTALSubjects that were randomized to receive the single vision frame glasses throughout the entire course of the study.
Interventions
Circular cylindrical mirror modulated frame glasses (compact)
Circular cylindrical mirror modulated frame glasses (strong defocus)
Eligibility Criteria
You may qualify if:
- years old;
- SER: -0.75 to -5.00 dioptres (D). Astigmatism and anisometropia of 1.50 D or less;
- Monocular best corrected visual acuity (VA) of 1.0 or better;
- Acceptance of random group allocation and the masked study design
- Voluntarily participate in the clinical trial and sign the informed consent;
You may not qualify if:
- Strabismus.
- Ocular and systemic abnormalities.
- Prior experience of myopia control.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tianjin Eye Hospital
Tianjin, 300020, China
Related Publications (2)
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.
PMID: 33811039BACKGROUNDMuller 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.
PMID: 38429067DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaoqin Chen, MD
Tianjin Eye Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2022
First Posted
March 21, 2022
Study Start
May 1, 2022
Primary Completion
October 15, 2023
Study Completion
December 31, 2024
Last Updated
December 28, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share