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

2026年7月2日 更新者:Ruihua Wei、Tianjin Medical University Eye Hospital
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.

調査の概要

状態

まだ募集していません

詳細な説明

Myopia, as a global visual health issue, has seen a rising incidence in recent years, with a trend toward younger age of onset. It is projected that by 2050, nearly five billion people worldwide will be affected by myopia, of whom approximately one billion will be at risk of high myopia. Due to increasing academic demands, prolonged reading or use of electronic devices, and a marked lack of outdoor activity time, the prevalence of myopia among children and adolescents in China has been escalating. Children and adolescents are in a critical period of visual development; the presence and progression of myopia may lead to an earlier onset and increased prevalence of a range of chronic eye diseases and retinal disorders, seriously affecting their physical and mental health as well as future development.

In response to this major public health concern, professionals in the field of ophthalmology have focused on myopia control research and practice, establishing a comprehensive management system based on three major approaches: behavioural intervention, optical correction, and pharmacological therapy. Various myopia control interventions have been rapidly adopted in daily life, ranging from conventional spectacles to defocus-inducing spectacles with myopia control functions, orthokeratology (OK) lenses, and low-concentration atropine ophthalmic preparations. Conventional spectacles, as the most widely used refractive correction method, offer high safety and affordability but lack a significant myopia control effect. Defocus-inducing spectacles create a special non-focused optical zone in front of the retina, producing myopic defocus that signals the brain to slow axial elongation; they also affect choroidal thickness and choroidal blood flow, thereby controlling ocular growth and myopia progression. However, the visual system's adaptation to the defocus design can cause peripheral blurring. OK lenses are rigid gas-permeable contact lenses with reverse-geometry design that correct myopia and astigmatism; during the correction process, they alter corneal morphology and tear film stability, thereby affecting visual quality. 0.01% atropine sulfate eye drops are a commonly used ophthalmic medication that slows myopia progression and inhibits axial elongation, but they also suppress ciliary muscle accommodation, leading to reduced accommodative amplitude and blurred near vision. Repeated low-level red-light (RLRL) therapy is a non-pharmacological intervention based on photobiomodulation (PBM) and has demonstrated good efficacy in controlling axial elongation and refractive error progression.

In clinical practice, it has been observed that during myopia control, children and adolescents may experience symptoms of asthenopia such as blurred vision, eye soreness, tearing, and inability to sustain reading, and may even exhibit adherence issues such as refusing to wear spectacles or discontinuing atropine without instruction. Asthenopia is a syndrome of visual disturbances and ocular discomfort, with or without systemic symptoms, caused by various factors that overload the visual system beyond its functional capacity. Over the past decade, especially since the outbreak of the COVID-19 pandemic in 2019, online teaching and video conferencing have become routine, and modern reading habits, learning styles, and leisure activities have increasingly relied on video terminals. Consequently, asthenopia has shown a trend toward younger age, with the prevalence in children rising from 10%-20% before the pandemic to 50%-65%. International studies have reported that approximately 89.9% of Malaysian students and 80.3% of Indian students suffer from computer vision syndrome, a subtype of asthenopia. During the COVID-19 pandemic, a survey of 1,825 adolescents in Hunan, Guizhou, Anhui, Shanghai and other regions of China found that about 51.1% of junior and senior high school students had asthenopia, indicating a concerning situation. The mechanisms underlying asthenopia involve multi-system interactions: when improper correction or suppressed accommodative function leads to a mismatch between accommodative demand and convergence, or when tear film instability causes dry eye symptoms, and when degraded retinal image quality increases neural load, all can precipitate asthenopia.

The Chinese Expert Consensus on the Diagnosis and Treatment of Asthenopia (2024) clearly states that myopia control interventions can also trigger or exacerbate asthenopia. In children with myopia, accommodative function declines and asthenopia symptoms worsen after three months of using 0.01% low-concentration atropine eye drops. Compared with conventional spectacles, wearing defocus-incorporated multiple segments (DIMS) spectacles can reduce asthenopia during visual search tasks in adolescents and adults. Acupuncture cycle therapy combined with atropine eye drops can effectively alleviate asthenopia while controlling myopia progression in school-aged children. In summary, different myopia control interventions have certain effects on asthenopia in children and adolescents. However, existing studies have mostly focused on the impact of single interventions on myopia and asthenopia, with a lack of systematic comparisons among conventional spectacles, defocus-inducing spectacles, OK lenses, low-concentration atropine, and multi-intervention combinations regarding their effects on asthenopia. Based on the above findings, we plan to investigate the influence of these myopia control interventions on asthenopia, assess the prevalence and severity of asthenopia among users of different correction modalities, and compare the differences in their effects on asthenopia, so as to provide evidence-based support for individualised clinical decision-making.

研究の種類

観察的

入学 (推定)

600

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人

健康ボランティアの受け入れ

なし

サンプリング方法

非確率サンプル

調査対象母集団

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

説明

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • ① Individuals residing in plateau or high-wind areas;

    • Individuals with a history of any ophthalmic surgery;

      • Individuals diagnosed with psychiatric disorders such as anxiety disorder, depressive disorder, bipolar disorder, or somatic symptom disorder by a psychiatrist, or those who have taken psychoactive medications (e.g., anxiolytics, antidepressants, sedative-hypnotics) within the past 3 months; ④ Individuals with ocular diseases or conditions including keratoconus, strabismus, conjunctivitis, amblyopia, high myopia, glaucoma, cataract, retinal nerve defects, or systemic diseases such as diabetes, hypertension, arthritis, osteoporosis, thyroid disease, chronic migraine, or chronic headache, or those taking medications known to potentially induce asthenopia; ⑤ Others: inability to cooperate with subjective questionnaire completion or objective examinations; or other conditions deemed unsuitable for inclusion by the investigators.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
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

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
eyestrain
時間枠:Cross-sectional assessment at a single time point
Occurrence of asthenopia in participants.
Cross-sectional assessment at a single time point

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年7月5日

一次修了 (推定)

2027年4月30日

研究の完了 (推定)

2027年4月30日

試験登録日

最初に提出

2026年7月2日

QC基準を満たした最初の提出物

2026年7月2日

最初の投稿 (実際)

2026年7月9日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月9日

QC基準を満たした最後の更新が送信されました

2026年7月2日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 2026RN15

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

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