Myopia Prevention With Reading Glasses
SMART2
An Open, Prospective Clinical Trial on the Use of Reading Glasses in Children to Prevent Myopia
1 other identifier
interventional
1,500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2023
Longer than P75 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
August 30, 2021
CompletedFirst Posted
Study publicly available on registry
September 1, 2021
CompletedStudy Start
First participant enrolled
October 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2031
February 23, 2023
February 1, 2023
8 years
August 30, 2021
February 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Development of myopia
Number of participants which develop myopia within the follow-up period of five years
Five years
Study Arms (2)
Glasses
ACTIVE COMPARATORThe participants are asked to wear reading glasses during near-work. The reading glasses have a lenspower of +2.0 diopters.
Control
NO INTERVENTIONAge matched children and adolescents, no intervention.
Interventions
The participants in the glasses-group are asked to wear the reading glasses during near-work.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Children who already wear glasses
- Astigmatism over 1.5 diopters
- Anisometropy greater than 1.5 diopters
- Eye diseases that affect refraction development
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Reis Augenklinik AG
Bendern, 9487, Liechtenstein
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander Reis, Prof. Dr.
Reis Augenklinik AG
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2021
First Posted
September 1, 2021
Study Start
October 1, 2023
Primary Completion (Estimated)
September 30, 2031
Study Completion (Estimated)
December 31, 2031
Last Updated
February 23, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share