Impact of Various Myopia Management Strategies on Asthenopia Among Pediatric and Adolescent Populations

NCT07691671 | Not Yet Recruiting

• 1 other identifier: 2026RN15
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

Different myopia control interventions have certain effects on ocular asthenopia in children and adolescents. As children and adolescents are in a critical period of visual development, the presence of asthenopia may lead to an earlier onset and increased prevalence of a range of chronic eye diseases and retinal disorders, thereby affecting their physical and mental health as well as future development. However, existing studies have mostly focused on single interventions, lacking a systematic comparison of the effects of multiple myopia control approaches on asthenopia. Therefore, the present study aims to investigate, through a cross-sectional survey, the impact of various myopia control interventions-including conventional spectacles, defocus-inducing spectacles, orthokeratology, low-concentration atropine, red-light therapy, and combined multi-intervention strategies-on asthenopia, to assess the prevalence and severity of asthenopia among users of different interventions, and to compare the differences in their effects on asthenopia. This will provide evidence-based support for the selection of individualised correction strategies in clinical practice and contribute to advancing clinical research on asthenopia in children and adolescents.

Conditions

Myopia; Visual Fatigue

Outcome Measures

Primary Outcomes (1)

• eyestrain

  Occurrence of asthenopia in participants.

  Cross-sectional assessment at a single time point

Study Arms (7)

conventional single-vision spectacle lenses

defocus-inducing spectacles (multifocal or peripheral defocus design)

orthokeratology (OK) lenses

low-concentration atropine eye drops

red-light therapy

no myopia control intervention

combination of the following interventions

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children and adolescents with myopia attending the Optometry Centre of Tianjin Medical University Eye Hospital

You may qualify if:

• ① Children and adolescents with myopia attending the Optometry Centre of Tianjin Medical University Eye Hospital;
• Age range 6-18 years, grouped by chronological age at 12 and 13 years into a children's group (6-12 years) and an adolescent group (13-18 years), irrespective of sex; ③ Current use of one or a combination of the following interventions: a. conventional single-vision spectacle lenses; b. defocus-inducing spectacles (multifocal or peripheral defocus design); c. orthokeratology (OK) lenses; d. low-concentration atropine eye drops (0.01%); e. red-light therapy; f. no myopia control intervention; ④ Best-corrected visual acuity (BCVA) ≥ 0.8 on the standard logarithmic visual acuity chart; ⑤ Written informed consent obtained from guardians, and assent obtained from children aged 8 years and older.

You may not qualify if:

• ① Individuals residing in plateau or high-wind areas;
• Individuals with a history of any ophthalmic surgery;

Sponsors & Collaborators

• Tianjin Medical University Eye Hospital: lead

MeSH Terms

Conditions

Myopia; Asthenopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 9, 2026
• Study Start: July 5, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share