MyopiaSMART2NCT05030103
Myopia Prevention With Reading Glasses
A study testing Reading glasses, +2.0 diopters in people with Myopia, run by Reis Augenklinik AG at 1 site in Liechtenstein.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Reading glasses, +2.0 diopters
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteLiechtenstein
- Study dates
- 1 Oct 2023to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Children who already wear glasses
- Astigmatism over 1.5 diopters
- Anisometropy greater than 1.5 diopters
- Eye diseases that affect refraction development
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Liechtenstein1 site
Reis Augenklinik AG
Bendern, 9487
Alexander Reis, Prof. Dr., +4233990424, info@augenklinik.li
Amir Nassri, Dr. med., +4233990424, info@augenklinik.li
About this study
Official title: An Open, Prospective Clinical Trial on the Use of Reading Glasses in Children to Prevent Myopia
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.
Read the 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"
- Conditions
- Myopia
- Being tested
- Reading glasses, +2.0 diopters
- Keywords
- Children, prevention
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reading glasses, +2.0 dioptersDevice
The participants in the glasses-group are asked to wear the reading glasses during near-work.
| Study group | Role | What they receive |
|---|---|---|
| Glasses | Active comparator | The participants are asked to wear reading glasses during near-work. The reading glasses have a lenspower of +2.0 diopters. Receives: Device: Reading glasses, +2.0 diopters |
| Control | No intervention | Age matched children and adolescents, no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of myopia
Number of participants which develop myopia within the follow-up period of five years
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start1 Oct 2023 (estimated)
- Primary completion30 Sep 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Open, propensity score method
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reis Augenklinik AG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Reis, Prof. Dr., Principal investigator, Reis Augenklinik AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030103
- Sponsor's protocol ID
- SMART2
- Acronym
- SMART2
- Status last verified
- Feb 2023
- First submitted
- 30 Aug 2021
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Prospective Clinical Trial on the Use of Reading Glasses in Children to Prevent Myopia
- ClinicalTrials.gov ID
- NCT05030103
- Acronym / sponsor ID
- SMART2 / SMART2
- Conditions
- Myopia
- Keywords
- Children, prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Reis Augenklinik AGUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 30 Sep 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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"
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open, propensity score method
| Arm | Type | Receives |
|---|---|---|
| Glasses | Active comparator | Device: Reading glasses, +2.0 dioptersThe participants are asked to wear reading glasses during near-work. The reading glasses have a lenspower of +2.0 diopters. |
| Control | No intervention | –Age matched children and adolescents, no intervention. |
Who may qualify
- Ages
- 6 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Children who already wear glasses
- Astigmatism over 1.5 diopters
- Anisometropy greater than 1.5 diopters
- Eye diseases that affect refraction development
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reading glasses, +2.0 dioptersThe participants in the glasses-group are asked to wear the reading glasses during near-work. | Device | Glasses |
Primary outcome
Development of myopia
Time frame: Five years
Number of participants which develop myopia within the follow-up period of five years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexander Reis, Prof. Dr. principal investigator
Reis Augenklinik AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reading glasses, +2.0 diopters in people with Myopia, run by Reis Augenklinik AG at 1 site in Liechtenstein.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Liechtenstein. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Reis, Prof. Dr. (+4233990424, info@augenklinik.li), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of myopia (time frame: Five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.