Myopia Prevention With Reading Glasses (SMART2)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myopia
• Intervention / Treatment: Device: Reading glasses, +2.0 diopters

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 Type: Interventional
• Enrollment (Anticipated): 1500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Liechtenstein
  • Bendern, Liechtenstein, 9487
    • Reis Augenklinik AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Children of both sexes from the age of 6
2. Children whose parents have read and signed the declaration of consent
3. Spherical equivalent of refraction <-0.5 dpt.
4. Distant vision in both eyes without correction 1.0
5. Willingness to wear reading glasses
6. Possibility of a five-year follow-up

Exclusion Criteria:

1. Children who already wear glasses
2. Astigmatism over 1.5 diopters
3. Anisometropy greater than 1.5 diopters
4. Eye diseases that affect refraction development

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Glasses; The participants are asked to wear reading glasses during near-work. The reading glasses have a lenspower of +2.0 diopters.	Device: Reading glasses, +2.0 diopters; The participants in the glasses-group are asked to wear the reading glasses during near-work.
No Intervention: Control; Age matched children and adolescents, no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of myopia	Number of participants which develop myopia within the follow-up period of five years	Five years

Collaborators and Investigators

• Sponsor: Reis Augenklinik AG

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2023
• Primary Completion (Anticipated): September 30, 2031
• Study Completion (Anticipated): December 31, 2031

Study Registration Dates

• First Submitted: August 30, 2021
• First Submitted That Met QC Criteria: August 30, 2021
• First Posted (Actual): September 1, 2021

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Children, prevention
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: SMART2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No