Back to resultsMyopia Preventing With Distance-image Screen (DIS)
Primary Purpose
Myopia, Progressive
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
distance-image screen
Sponsored by
About this trial
This is an interventional prevention trial for Myopia, Progressive focused on measuring Myopia; children
Eligibility Criteria
Inclusion Criteria: (1) Must be 6~12 years old; (2) Must be best corrected visual acuity < logMAR: 0.1; (3) Spherical Equivalence (SE) must be -1.00~ + 6.00 Diopter (D), (4) Spherical Equivalence (SE) must have changed > 1.25 Diopter (D) in the recent 2 years; (5) Must be astigmatism <1.75 Diopter (D); (6) Must be anisometropia <1.75 Diopter(D). Exclusion Criteria: (1) Strabismus disease; (2) Amblyopia disease; (3) Cataract disease; (4) Glaucoma disease; (5) Severe dry eye disease; (6) Cannot use distance-image screen for 12 month; (7) Other severe diseases that would effect the use of distance-image screen.
Sites / Locations
- Airdoc MPC Opthalmology ClinicsRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Distance -image screen
Arm Description
Distance -image screen is a device to make image in the distance of 6-meters when reading and learning at near. The investigators will ask the subjects to use the distance - image screen for 12 month
Outcomes
Primary Outcome Measures
Changes of ocular axial length (mm)
IntraOcularLens (IOL) master biometry will exam each eye before the testing and after the testing with distance-image screen
Changes of refractive error (D)
Cycloplegic refraction with autorefractor will test each eye before the testing and after the testing with distance-image screen
Secondary Outcome Measures
Changes of center macular thickness (um)
Optic Coherent Topograph (OCT) of macular fovea central thickness will be made to compare the thickness before and after using distance-image screen
Changes of subretina choroidal thickness (um)
Optic Coherent Topograph (OCT) with Enhanced Depth Imaging (EDI) scan of macular fovea central thickness will be done to compare the thickness before and after using distance-image screen
Changes of other regions choroidal thickness (um)
Optic Coherent Topograph (OCT) with Enhanced Depth Imaging (EDI) scan of other regions choroidal thickness will be done to compare the thickness before and after using distance-image screen
Full Information
NCT ID
NCT06088225
First Posted
October 12, 2023
Last Updated
October 20, 2023
Sponsor
Beijing Airdoc Technology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT06088225
Brief Title
Myopia Preventing With Distance-image Screen
Acronym
DIS
Official Title
Clinically Study the Ocular Axial Length and Sphere Equivalence Changes of Children With Distance-image Screen Usage for One Year
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Airdoc Technology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is for testing the efficacy and safety of distance-image screens for preventing myopia in children for 12 month. Each subjects would be asked to paired test the ocular parameters between before and after 12-month distance-image screens.
Detailed Description
This study is for testing the efficacy and safety of distance-image screens intended usage for preventing myopia in children with reading after a 6-meter-distant-image device. It was a prospective study. The investigators would like to recruit 100 volunteers, aged 6 years 16 in Beijing.
All the volunteers will be complete examined their ocular parameters before using the distant-image screen in a random order for at least 2 hours daily for 12 month. The changes of ocular axial length and refractive error were both calculated before and after 12-month usage for paired t-test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Progressive
Keywords
Myopia; children
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Paired testing those ocular parameters before and after 12-month usage of distance-image screen
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Distance -image screen
Arm Type
Experimental
Arm Description
Distance -image screen is a device to make image in the distance of 6-meters when reading and learning at near. The investigators will ask the subjects to use the distance - image screen for 12 month
Intervention Type
Device
Intervention Name(s)
distance-image screen
Intervention Description
Distance-image screen is a screen make each image at distance of 6-meters to reduce the accommodation and convergence for eyes during the reading and learning with screens.
Primary Outcome Measure Information:
Title
Changes of ocular axial length (mm)
Description
IntraOcularLens (IOL) master biometry will exam each eye before the testing and after the testing with distance-image screen
Time Frame
12-month
Title
Changes of refractive error (D)
Description
Cycloplegic refraction with autorefractor will test each eye before the testing and after the testing with distance-image screen
Time Frame
12-month
Secondary Outcome Measure Information:
Title
Changes of center macular thickness (um)
Description
Optic Coherent Topograph (OCT) of macular fovea central thickness will be made to compare the thickness before and after using distance-image screen
Time Frame
12-month
Title
Changes of subretina choroidal thickness (um)
Description
Optic Coherent Topograph (OCT) with Enhanced Depth Imaging (EDI) scan of macular fovea central thickness will be done to compare the thickness before and after using distance-image screen
Time Frame
at 12-month
Title
Changes of other regions choroidal thickness (um)
Description
Optic Coherent Topograph (OCT) with Enhanced Depth Imaging (EDI) scan of other regions choroidal thickness will be done to compare the thickness before and after using distance-image screen
Time Frame
12-month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
(1) Must be 6~12 years old;
(2) Must be best corrected visual acuity < logMAR: 0.1;
(3) Spherical Equivalence (SE) must be -1.00~ + 6.00 Diopter (D),
(4) Spherical Equivalence (SE) must have changed > 1.25 Diopter (D) in the recent 2 years;
(5) Must be astigmatism <1.75 Diopter (D);
(6) Must be anisometropia <1.75 Diopter(D).
Exclusion Criteria:
(1) Strabismus disease;
(2) Amblyopia disease;
(3) Cataract disease;
(4) Glaucoma disease;
(5) Severe dry eye disease;
(6) Cannot use distance-image screen for 12 month;
(7) Other severe diseases that would effect the use of distance-image screen.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
QIU JENNY, MD
Phone
+8618510386815
Email
kkaiqiu@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Huadong AI, OD
Email
aihuadong@airdoc.com
Facility Information:
Facility Name
Airdoc MPC Opthalmology Clinics
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100089
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HUADONG Ai, OD
Phone
+8613811449846
Email
drqiu666@126.com
First Name & Middle Initial & Last Name & Degree
QIU JENNY
Phone
+8618510386815
Email
kkaiqiu@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Myopia Preventing With Distance-image Screen
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