Myopia Prevention With Reading Glasses (SMART2)
Primary Purpose
Myopia
Status
Not yet recruiting
Phase
Not Applicable
Locations
Liechtenstein
Study Type
Interventional
Intervention
Reading glasses, +2.0 diopters
Sponsored by
About this trial
This is an interventional prevention trial for Myopia focused on measuring Children, prevention
Eligibility Criteria
Inclusion Criteria:
- Children of both sexes from the age of 6
- Children whose parents have read and signed the declaration of consent
- Spherical equivalent of refraction <-0.5 dpt.
- Distant vision in both eyes without correction 1.0
- Willingness to wear reading glasses
- Possibility of a five-year follow-up
Exclusion Criteria:
- Children who already wear glasses
- Astigmatism over 1.5 diopters
- Anisometropy greater than 1.5 diopters
- Eye diseases that affect refraction development
Sites / Locations
- Reis Augenklinik AG
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Glasses
Control
Arm Description
The participants are asked to wear reading glasses during near-work. The reading glasses have a lenspower of +2.0 diopters.
Age matched children and adolescents, no intervention.
Outcomes
Primary Outcome Measures
Development of myopia
Number of participants which develop myopia within the follow-up period of five years
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05030103
Brief Title
Myopia Prevention With Reading Glasses
Acronym
SMART2
Official Title
An Open, Prospective Clinical Trial on the Use of Reading Glasses in Children to Prevent Myopia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
September 30, 2031 (Anticipated)
Study Completion Date
December 31, 2031 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reis Augenklinik AG
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
The last decades have seen a significant increase in myopia in children and young adults. Possible cause: increased near-work (school, computer, smartphone). Rationale: Reading glasses support the accommodative effort of the eyes. By wearing reading glasses, there is less interference with the young eye´s physiological axial growth despite increased near-work. Main objective: does the use of reading glasses during near-work in children and adolescents reduce the incidence of myopia.
Detailed Description
In myopia (nearsightedness), the eyeball is relatively to long, which means that the image produced by the cornea and lens is displayed in front of the retina.
The axial length of an adult eye is on average around 23 millimeters. Every millimeter of additional length must be corrected with a -2.75 diopter lens.
In newborns, the eyeball is about 18 millimeters long. It is believed that there are feedback loops during childhood and adolescence to control the growth of the eye.
Epidemiological studies show that myopia is an increasing health problem. There is a growing body of epidemiological evidence that environmental factors can influence the development of myopia.
The link between the environment and myopia lies in the quality of the retinal image. Experimental studies in various species have shown that if the retinal image is missing, eye growth is disturbed. Of even greater importance for the development of myopia is the knowledge that the primate eye can change its growth, depending on the strength and type of blurring of the retinal image: if lenses are placed in front of the eye during development, the eye growth changes in such a way that a sharp retinal image is achieved through these lenses. If divergent lenses are placed in front of the eye, the eye becomes longer, and if convergent lenses are placed in front of it, it becomes correspondingly shorter.
So myopia is the result of a failure in these emmetropization mechanisms. The positive correlation of myopia with a higher level of education suggests that increased close work interferes with emmetropization. The growth in length of the eye changes in such a way that it adapts to this requirement: the eye adjusts itself to the close work: it becomes myopic.
Myopia is thus possibly a physiological adaptation to increased near work with the aim of improving the quality of the retinal image during close work. However, this can only be achieved at the expense of the image quality when looking into the distance.
The investigators submitted a study on this subject to the Cantonal Ethics Committee of the Canton of Zurich in 2003:
"An open, prospective, randomized study on the use of reading glasses in children with normal vision to prevent myopia" Unique Protocol ID: FR-2005-01-01 Approval Status: Approved Approval Number: KEK-StV-Nr. 19/03
This was and is so far the only clinical study that examined the effect of reading glasses on the development of myopia in emmetropic (normally sighted) children and has led to Patent No: US 8,511,819 B2, Aug. 20, 2013 "Prevention of myopia acquisition in children and young adults using reading glasses"
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
Children, prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open, propensity score method
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Glasses
Arm Type
Active Comparator
Arm Description
The participants are asked to wear reading glasses during near-work. The reading glasses have a lenspower of +2.0 diopters.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Age matched children and adolescents, no intervention.
Intervention Type
Device
Intervention Name(s)
Reading glasses, +2.0 diopters
Intervention Description
The participants in the glasses-group are asked to wear the reading glasses during near-work.
Primary Outcome Measure Information:
Title
Development of myopia
Description
Number of participants which develop myopia within the follow-up period of five years
Time Frame
Five years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children of both sexes from the age of 6
Children whose parents have read and signed the declaration of consent
Spherical equivalent of refraction <-0.5 dpt.
Distant vision in both eyes without correction 1.0
Willingness to wear reading glasses
Possibility of a five-year follow-up
Exclusion Criteria:
Children who already wear glasses
Astigmatism over 1.5 diopters
Anisometropy greater than 1.5 diopters
Eye diseases that affect refraction development
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Reis, Prof. Dr.
Phone
+4233990424
Email
info@augenklinik.li
First Name & Middle Initial & Last Name or Official Title & Degree
Amir Nassri, Dr. med.
Phone
+4233990424
Email
info@augenklinik.li
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Reis, Prof. Dr.
Organizational Affiliation
Reis Augenklinik AG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reis Augenklinik AG
City
Bendern
ZIP/Postal Code
9487
Country
Liechtenstein
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Reis, Prof. Dr.
Phone
+4233990424
Email
info@augenklinik.li
First Name & Middle Initial & Last Name & Degree
Amir Nassri, Dr. med.
Phone
+4233990424
Email
info@augenklinik.li
12. IPD Sharing Statement
Plan to Share IPD
No
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Myopia Prevention With Reading Glasses
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