Comparing Myopia Control Spectacle Lenses for Visual Comfort, Adaptation, and Satisfaction in Myopic Children (EVASION)
2026年7月2日 更新者：Essilor International
Evaluation of Visual Comfort, Adaptation, and Satisfaction With a Myopia Control Lens in Myopic Children
The goal of this clinical trial is to demonstrate that the visual comfort, adaptation, and overall satisfaction associated with the use of the test spectacle lenses are not inferior to those of the control spectacle lenses in myopic children age ≥ 6 years and < 11 years old, both male and female, with no systemic or ocular anomalies. The main question it aims to answer is:
Do children adapt to the test spectacle lenses within the first 1-2 weeks of wear without significant symptoms or complaints?
Is the level of visual comfort and overall satisfaction with test spectacle lenses comparable to that of control spectacle lenses during the early adaptation period?
Researchers will compare questionnaire responses between participants wearing test lenses and those wearing control lenses to assess whether the test lenses are non-inferior in terms of visual comfort, adaptation, and user satisfaction.
Participants will:
- Wear the study spectacles for 2 weeks
- Respond to questionnaires 4 days after dispensing and at 2 weeks
- Visit Essilor R&D Centre for screening, dispensing and follow up sessions
調査の概要
研究の種類
介入
入学 (推定)
20
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。
研究連絡先
- 名前：Celine Carimalo
- 電話番号：+65 67134617
- メール：carimalc@essilor.com.sg
研究連絡先のバックアップ
- 名前：Thomas Boudenne
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
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Volunteer participant who is willing and able to comply with all scheduled study visits.
- Informed consent of parent/guardian and assent of participant.
- Age ≥ 6 years and < 11 years at the time of signing informed consent and assent.
- Spherical equivalent refraction (SER) equal or less than -0.50D and equal or greater than -4.75D with astigmatism not more than 2.00 D on both eyes.
- Difference in SER (anisometropia) between two eyes should not exceed 1.50 D.
- Best corrected Distance Visual Acuity (BCDVA) better than or equal to +0.10 LogMAR in each eye.
- Be in good general health, based on the participant and the parent's/guardian's knowledge.
Exclusion Criteria:
- History of Atropine, Orthokeratology, Contact Lens or Red Light treatment.
- Strabismus by cover test at near or distance wearing correction.
- History and presence of amblyopia.
- Any ocular or systemic condition known to affect refractive status (e.g. keratoconus, diabetes, Downs syndrome, or other developmental disorders, etc.).
- Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
- History of ocular injury or surgery.
- Participation in any clinical study within 30 days of the Baseline visit.
- Sibling of existing participant of this study
- Study participants deemed inappropriate for the study by the investigator.
- The inherent ocular/systemic discomfort (dry eyes, visual fatigue, headaches, etc.) that may affect the evaluation of the study lens wearing experience, from the investigator's perspective.
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：支持療法
- 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：Test
Test Lens
|
Dispense to Test group for 2 weeks
|
|
アクティブコンパレータ：Control
Control Lens
|
Dispense to Control group for 2 weeks
|
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 |
|---|---|---|
|
Successful Adaptation Rate Within 1 Week After Dispensing
時間枠：Within 1 week post dispensing
|
Proportion of children who meet all of the following criteria at the 1-week visit:
Non-inferiority of the test lenses will be evaluated against the control lenses based on the between-group difference in adaptation success rates, using a pre-specified non-inferiority margin. |
Within 1 week post dispensing
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Successful Adaptation Rates at Early and Later Timepoints
時間枠：4 days and 2 weeks post-dispensing
|
Proportion of children who meet all of the following criteria at approximately Day 4 and Week 2 post-dispensing:
Between-group differences in adaptation success rates between the test and control spectacle lenses will be evaluated at both timepoints. |
4 days and 2 weeks post-dispensing
|
|
Average daily and weekly wearing time
時間枠：Assessed at Day 4 and Week 2 post-dispensing
|
Mean daily wearing time (hours/day) and total weekly wearing time (hours/week) of the assigned study spectacles will be compared between the test and control groups, based on participant/parent-reported wear time.
|
Assessed at Day 4 and Week 2 post-dispensing
|
|
Activity-specific visual comfort
時間枠：4 days and 2 weeks post-dispensing
|
Participant-reported visual comfort during daily activities (including far vision, intermediate vision, near vision with and without digital devices, and overall vision) will be evaluated using the specific comfort subscale items from the unabbreviated Visual Comfort and Adaptation Questionnaire (Child).
Individual comfort items are rated on a 4-point Likert scale ranging from 1 (Strongly disagree) to 4 (Strongly agree).
Negatively worded comfort questions are reverse-coded prior to analysis so that all values are directionally aligned.
The subscale score is calculated as the mean of these items, yielding a minimum value of 1 and a maximum value of 4, where a higher score indicates a better outcome (greater visual comfort during daily activities).
Between-group differences between the test and control spectacle lenses will be evaluated at each specified timepoint.
|
4 days and 2 weeks post-dispensing
|
|
Overall satisfaction
時間枠：4 days and 2 weeks post-dispensing
|
Overall satisfaction with the study spectacles will be evaluated using the satisfaction subscale items (e.g., "I hate wearing the new spectacles" and "I like my new spectacles") from the unabbreviated Visual Comfort and Adaptation Questionnaire (Child).
Individual items are rated on a 4-point Likert scale ranging from 1 (Strongly disagree) to 4 (Strongly agree).
Negatively worded items are reverse-coded during data analysis.
Subscale scores are calculated as the mean of the items, ranging from a minimum value of 1 to a maximum value of 4, where higher scores indicate a better outcome (higher satisfaction with the spectacles).
Between-group differences between the test and control spectacle lenses will be evaluated at each specified timepoint.
|
4 days and 2 weeks post-dispensing
|
|
High-contrast visual acuity (distance and near)
時間枠：At dispensing (baseline) and 2 weeks post-dispensing
|
Monocular and binocular high-contrast visual acuity at distance and near, measured while wearing study spectacles, will be compared between the test and control groups.
|
At dispensing (baseline) and 2 weeks post-dispensing
|
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
捜査官
- 主任研究者：Sheron Quak、Essilor R&D Centre Singapore
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6月1日
一次修了 (推定)
2026年10月1日
研究の完了 (推定)
2026年11月1日
試験登録日
最初に提出
2026年6月17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6日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月6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6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。