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Advanced Technology for Myopia Control in Children and Young Adults (MyopiaTech)

2026年6月20日 更新者：Dr Memoona Arshad、University of Faisalabad

Role of Advanced Technological Approaches for Myopia Control in Myopic Patients: A Randomized Controlled Trial of Lenslet Spectacles vs. Violet Excitation Filter Glasses vs. Single Vision Lenses

Myopia, or nearsightedness, is increasing rapidly worldwide, especially in children and young adults. This study tested two advanced treatments for slowing myopia progression with one control group: special lenslet spectacles (Stellest with highly aspherical lenslet technology) and violet excitation filter glasses (wavelength 420 nm) and Single vision lenses for controls. The study enrolled 90 participants aged 8 to 20 years from schools and universities in Faisalabad, Pakistan. Participants were randomly assigned to one of three groups: lenslet spectacles, violet filter glasses, or single vision lenses (control group). Visual acuity, contrast sensitivity, Spherical Equivalent and axial length were measured at the start and again after 3, 6, and 9 months and one follow up after cessation of treatment. The study aimed to determine whether these advanced technologies can effectively slow myopia progression compared to standard glasses, providing head-to-head evidence on emerging and established optical interventions for myopia control.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

This is a randomized controlled trial (RCT) with three parallel groups. The study was conducted at schools and the Universities in Faisalabad, Pakistan. The total study duration was almost one year (July 2025 to May 2026), with each participant undergoing atleast 3 months of active treatment with 3 follow ups. The sample size was 30 participants per group (total N=90), after drop put of patients, calculated using G*Power (repeated measures ANOVA, 3 groups × 4 time points, medium effect size f=0.25, α=0.05, power=0.8). Simple random sampling was used, with participants allocated to groups using an online research randomizer. Inclusion criteria: axial myopia (high, moderate, or severe), age 8-20 years, both genders, willingness to wear glasses. Exclusion criteria:

other ametropia, contact lens users, prior myopia treatment, ocular or systemic disease, ocular surgery, non-cooperative patients. Lenslet group: Essilor Stellest spectacles with Highly Aspheric Lenslet Target technology, 1.6mm thickness, refractive index 1.56, UV 400nm protection, antireflective coating; worn all waking hours. Violet filter group: plastic lenses with 420nm violet excitation filter; worn 3 hours daily (11 AM to 2 PM) to align with circadian rhythm. Control group: single vision lenses (refractive index 1.56). Primary outcome measures: change in axial length (measured by ocular biometer) and change in cycloplegic refraction. Secondary outcome measures: visual acuity (LogMAR chart), contrast sensitivity (Vistech chart). Follow-up assessments at 3, 6, and 9 months. Statistical analysis: repeated measures Linear mixed model using SPSS version 26 to compare within-group and between-group changes.

研究の種類

介入

入学 (実際)

90

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • パキスタン
    • Punjab Province
      • Faisalābad、Punjab Province、パキスタン、3800
        • The University of Faisalabad

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

いいえ

説明

Inclusion Criteria:

  • Diagnosis of axial myopia (high, moderate, or severe)
  • Age between 8 and 20 years (inclusive)
  • Male or female
  • Willingness to wear prescribed glasses as instructed
  • Willingness to attend all follow-up visits (3, 6, and 9 months)
  • Written informed consent from participant or parent/guardian for minors

Exclusion Criteria:

  • Any ametropia other than axial myopia (e.g., hyperopia, astigmatism >1.50D)
  • Current contact lens users
  • Prior or concurrent myopia treatment other than study interventions
  • Any ocular disease (e.g., cataract, glaucoma, retinal disorders)
  • Any systemic disease affecting vision (e.g., diabetes, Marfan syndrome)
  • History of any ocular surgery
  • Allergic or physical intolerance to glasses materials
  • Non-cooperative patients unwilling to comply with study procedures

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

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：Lenslet Spectacles (HALT Technology
Participants receive Essilor Stellest spectacle lenses featuring HALT (Highly Aspheric Lenslet Target) anf violet filter glasses technology. Lenses have 1.6mm thickness, refractive index 1.56, UV 400. Participants are instructed to wear glasses throughout all waking hours for 9 months and for VF atleast 3ours.
デバイス：Lenslet Spectacles
The lenslet spectacles are specially designed spectacle lenses featuring HALT (Highly Aspheric Lenslet Target) technology manufactured by Essilor International (Serial Number: 72426930). The lens design includes a clear distance zone in the center with peripheral areas providing single vision correction. Technical specifications: 5H green covering, multi-dimensional pattern, 1.6mm thickness, refractive index 1.56, UV 400nm protection, antireflective coating. Participants are instructed to wear the spectacles throughout all waking hours. Each participant receives a new pair at baseline. No adjustments are made during the 12-month treatment period unless vision changes require prescription update.
実験的：Violet Excitation Filter Glasses
Participants receive prescription glasses with violet excitation filter (420 nm wavelength, CR-39 material). Participants are instructed to wear glasses for 3 hours daily (11 AM to 2 PM) for 12 months to align with circadian rhythm.
デバイス：Violet Excitation Filter Glasses
The violet excitation filter glasses are prescription glasses incorporating a violet light filter with wavelength 420 nm (range 360-420 nm). Material: CR-39. Filter intensity: 700 nm. Wavelength verified using spectrophotometer (standard error ±0.1 to 1 nm). Participants are instructed to wear the glasses for 3 hours daily, specifically from 11 AM to 2 PM, to optimize impact on circadian rhythm while avoiding disruption of sleep patterns. Each participant receives a new pair at baseline. The filter is integrated into the prescription lenses.
アクティブコンパレータ：Single Vision Lenses
Participants receive standard single vision spectacle lenses (SVS index 1.56). Participants are instructed to wear glasses throughout all waking hours for 12 months.
デバイス：Single Vision Lenses
Standard single vision spectacle lenses (SVS index 1.56) with no myopia control features. These are conventional prescription glasses that correct refractive error but do not incorporate lenslet technology or violet filtering. Participants are instructed to wear the glasses throughout all waking hours. Each participant receives a new pair at baseline.

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
Change in Axial Length
時間枠：Baseline, Month 3, Month 6, Month 9
Axial length (mm) measured using an A-SCAN biometer (Scanmate 677AB). The measurement represents the distance from the corneal apex to the retinal pigment epithelium. Three measurements are taken for each eye and averaged. This is a continuous anatomical measurement with no theoretical minimum or maximum score. Higher values indicate greater ocular elongation, which is associated with worsening myopia progression.
Baseline, Month 3, Month 6, Month 9
Change in Cycloplegic Refraction
時間枠：Baseline, Month 3, Month 6, Month 9
Cycloplegic spherical equivalent refraction (SER), measured in diopters (D) using retinoscopy (Welch Allyn) after cycloplegia. SER is calculated as sphere + (cylinder/2). This is a continuous measurement with no theoretical minimum or maximum value. A decrease in SER (more negative values) reflects progression of myopia, while an increase in SER (less negative or more positive values) reflects reduced myopia or a shift toward hyperopia.
Baseline, Month 3, Month 6, Month 9

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Visual Acuity
時間枠：Baseline, Month 3, Month 6, Month 9
Visual acuity measured using the Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity Chart (Precision Vision) at 4 m, 2 m, and 1 m. LogMAR scores typically range from approximately -0.30 (better visual acuity) to 1.60 (poorer visual acuity), although values may extend beyond these limits. Lower scores represent better visual acuity outcomes, and higher scores represent worse visual acuity outcomes.
Baseline, Month 3, Month 6, Month 9
Change in Contrast Sensitivity
時間枠：Baseline, Month 3, Month 6, Month 9
Contrast sensitivity measured using the Vistech Contrast Sensitivity Test Chart (Precision Vision) at 1 meter. Contrast sensitivity scores are reported in log contrast sensitivity units and typically range from 0.00 to approximately 2.25. Higher scores represent better contrast sensitivity and visual performance, while lower scores represent poorer contrast sensitivity and visual performance.
Baseline, Month 3, Month 6, Month 9

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。

スポンサー

University of Faisalabad

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

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 (実際)

2025年7月1日

一次修了 (実際)

2026年5月30日

研究の完了 (実際)

2026年6月6日

試験登録日

最初に提出

2026年6月8日

QC基準を満たした最初の提出物

2026年6月8日

最初の投稿 (実際)

2026年6月12日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月25日

QC基準を満たした最後の更新が送信されました

2026年6月20日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • TUF/IRB/ 38 /25

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