Evaluate the Safety and Efficacy of Two Types of Circular Column Modulated Lenses for Delaying the Progression of Myopia
Primary Purpose
Myopia
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Circular cylindrical mirror modulated frame glasses (compact)
Circular cylindrical mirror modulated frame glasses (strong defocus)
single vision frame glasses
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- 6-13 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;
Exclusion Criteria:
- Strabismus.
- Ocular and systemic abnormalities.
- Prior experience of myopia control.
- Only one eye meets the inclusion criteria.
Sites / Locations
- Tianjin Eye Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Circular cylindrical mirror modulated frame glasses (compact)
Circular cylindrical mirror modulated frame glasses (strong defocus)
single vision frame glasses
Arm Description
Subjects that were randomized to receive the Circular cylindrical mirror modulated frame glasses (compact) throughout the entire course of the study.
Subjects that were randomized to receive the Circular cylindrical mirror modulated frame glasses (strong defocus) throughout the entire course of the study.
Subjects that were randomized to receive the single vision frame glasses throughout the entire course of the study.
Outcomes
Primary Outcome Measures
Changes in ocular axial length in a year
The ocular axial length was measured by AL-scan
Secondary Outcome Measures
Changes in cycloplegic objective spherical equivalent in a year
The cycloplegic objective spherical equivalent was evaluated by a autorefractor
Full Information
NCT ID
NCT05288335
First Posted
February 10, 2022
Last Updated
December 25, 2022
Sponsor
Tianjin Eye Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05288335
Brief Title
Evaluate the Safety and Efficacy of Two Types of Circular Column Modulated Lenses for Delaying the Progression of Myopia
Official Title
Muti-center Clinical Trial to Evaluate the Safety and Efficacy of Two Types of Circular Column Modulated Lenses for Delaying the Progression of Myopia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Eye Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Clinical trial to evaluate the safety and effectiveness of two kinds of ring band cylindrical lens in delaying the progression of myopia
Detailed Description
Two-hundered and forty children aged 6-13 will be recruited and allocated to three groups. Subjects that were randomized to receive Circular cylindrical mirror modulated frame glasses (compact), Circular cylindrical mirror modulated frame glasses (strong defocus) or single vision frame glasses, respectively.
Primary outcome measure ocular axial length and the secondary indicator is spherical equivalent after cycloplegia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Circular cylindrical mirror modulated frame glasses (compact)
Arm Type
Experimental
Arm Description
Subjects that were randomized to receive the Circular cylindrical mirror modulated frame glasses (compact) throughout the entire course of the study.
Arm Title
Circular cylindrical mirror modulated frame glasses (strong defocus)
Arm Type
Experimental
Arm Description
Subjects that were randomized to receive the Circular cylindrical mirror modulated frame glasses (strong defocus) throughout the entire course of the study.
Arm Title
single vision frame glasses
Arm Type
Experimental
Arm Description
Subjects that were randomized to receive the single vision frame glasses throughout the entire course of the study.
Intervention Type
Device
Intervention Name(s)
Circular cylindrical mirror modulated frame glasses (compact)
Intervention Description
Circular cylindrical mirror modulated frame glasses (compact)
Intervention Type
Device
Intervention Name(s)
Circular cylindrical mirror modulated frame glasses (strong defocus)
Intervention Description
Circular cylindrical mirror modulated frame glasses (strong defocus)
Intervention Type
Device
Intervention Name(s)
single vision frame glasses
Intervention Description
single vision frame glasses
Primary Outcome Measure Information:
Title
Changes in ocular axial length in a year
Description
The ocular axial length was measured by AL-scan
Time Frame
baseline, 12 months
Secondary Outcome Measure Information:
Title
Changes in cycloplegic objective spherical equivalent in a year
Description
The cycloplegic objective spherical equivalent was evaluated by a autorefractor
Time Frame
baseline, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
6-13 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;
Exclusion Criteria:
Strabismus.
Ocular and systemic abnormalities.
Prior experience of myopia control.
Only one eye meets the inclusion criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoqin Chen, MD
Organizational Affiliation
Tianjin Eye Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tianjin Eye Hospital
City
Tianjin
ZIP/Postal Code
300020
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33811039
Citation
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.
Results Reference
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Evaluate the Safety and Efficacy of Two Types of Circular Column Modulated Lenses for Delaying the Progression of Myopia
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