小児における片眼性弱視治療のためのAmblyoFixの評価
小児の片眼性弱視に対するAmblyoFix治療を評価する前向き臨床試験
This is a prospective, single-arm, non-inferiority clinical trial designed to evaluate the efficacy, safety, and adherence of AmblyoFix binocular digital therapy for the treatment of unilateral amblyopia in children aged 7 to 12 years. Outcomes will be compared against a retrospective cohort of patients of the same age range previously treated with standard occlusion (patching) at the same clinic.
A total of 33 participants will be enrolled, allowing for up to 15% attrition to ensure at least 28 evaluable completers at Week 24. Eligible participants must have unilateral amblyopia with amblyopic-eye best-corrected visual acuity (BCVA) between 0.3 and 1.3 logMAR and an interocular difference of at least 0.2 logMAR, with stable refractive correction for at least 16 weeks prior to enrollment.
The primary outcome is the change in amblyopic-eye BCVA (logMAR) from baseline to Week 24, assessed under standardized Snellen or ETDRS protocol by certified, masked outcome assessors. Secondary outcomes include adherence (captured via in-software usage logs), safety (BCVA worsening ≥2 lines and ocular adverse events), and patient-reported outcomes (acceptability, usability, satisfaction). An interim analysis will be conducted at Week 6 and at Week 12 to review early efficacy and safety, with the option to recommend early termination if robust evidence of non-inferiority is demonstrated.
In addition to the primary study population of unilateral amblyopia, an exploratory subgroup of 3 or more participants with bilateral amblyopia may be enrolled for observational evaluation. Treatment will initially target the eye with worse BCVA as selected in the AmblyoFix software. Upon sufficient improvement, as determined by the Principal Investigator, treatment may be switched to the other eye within the software settings. Data from the bilateral exploratory cohort will be analyzed descriptively and reported separately. These data will not contribute to the primary non-inferiority analysis.
Participants and caregivers cannot be blinded due to the nature of the intervention; however, outcome assessors and statisticians will remain masked to study objectives and comparator data to minimize bias. Follow-up assessments will occur at baseline, Week 6, Week 12, and Week 24, with no additional amblyopia treatment permitted during the study unless clinically required.
This trial is designed to rigorously determine whether AmblyoFix is a safe, effective, and non-inferior alternative to patching, with the potential to improve adherence, usability, and acceptability in real-world amblyopia therapy.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Dr. Heba Fuoad, MD, PhD Ophthalmology
- 電話番号：+2012260616112
- メール：hebamfouad@watanyeyehospitals.com
研究場所
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-
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Cairo、エジプト
- 募集
- Watany Research and Development Center, Watany Eye Hospital
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コンタクト：
- Dr. Mohamed El Bahrawy
- 電話番号：+2012260616112
- メール：int.dept@watanyeyehospitals.com
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主任研究者：
- Dr. Heba Fuoad, MD, PhD Ophthalmology
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-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age 7-12 years.
- Unilateral amblyopia secondary to anisometropia and/or mild strabismus.
- BCVA in amblyopic eye between 20/40-20/400 (0.3-1.3 logMAR); fellow eye ≥20/32 (≤0.2 logMAR).
- Interocular difference ≥2 lines (≥0.2 logMAR).
- Stable refractive correction for ≥16 weeks or <0.1 logMAR change across two visits ≥8 weeks apart.
- Cycloplegic refraction within 7 months meeting anisometropia criteria (e.g., hyperopia ≥+2.50 D).
- Access to a suitable home environment (laptop and internet).
- Parent/guardian consent and child assent (7+ year olds).
Exclusion Criteria:
- Atropine use within 2 weeks before starting treatment
- Prior amblyopia treatment beyond refractive adaptation.
- Myopia >-6.00 D SE, previous ocular surgery, or other ocular pathology.
- Severe cognitive/developmental delay impeding compliance.
- History of light-induced seizures.
- Inability/unwillingness to comply with digital monitoring.
- Any condition compromising safety or trial integrity.
研究計画
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：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
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実験的：AmblyoFix
Participants assigned to this arm will undergo binocular vision therapy using the AmblyoFix software on a laptop, in combination with red-blue anaglyph glasses. Prior to therapy initiation, a calibration process will be completed and validated by the study team to ensure device screen specifications meet protocol requirements. Treatment consists of interactive, gamified visual tasks designed to stimulate the amblyopic eye under binocular viewing conditions. |
AmblyoFix is a binocular vision therapy delivered through specialized software on a laptop computer in combination with red-blue anaglyph glasses. The program uses interactive, gamified visual tasks designed to stimulate the amblyopic eye while maintaining binocular viewing conditions. Each participant undergoes a standardized calibration process to ensure screen specifications are validated before starting therapy. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in BCVA in the amblyopic eye from baseline to Week 24
時間枠：From enrollment to the end of treatment at 24 Weeks
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The primary outcome of this trial is the change in best-corrected visual acuity (BCVA) in the amblyopic eye from baseline to week 24, measured in logMAR units using the Snellen or ETDRS protocol. This approach was selected for its clinical validity, reproducibility, and alignment with international standards in amblyopia trials. Visual acuity will be assessed monocularly under best optical correction, with the fellow eye occluded during testing. Certified, masked outcome assessors will conduct all measurements in standardized conditions to minimize bias, with testing procedures (including lighting, calibration, and display specifications) harmonized. |
From enrollment to the end of treatment at 24 Weeks
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Adherence to AmblyoFix
時間枠：From enrollment to the end of treatment at 24 Weeks
|
Adherence will be objectively measured through the AmblyoFix software's built-in time-tracking functions, which automatically record session frequency and duration. Adherence will be calculated as the total minutes of active use per week compared with the prescribed target duration. Mean weekly adherence will be derived over the 24-week treatment period. Unit of Measure: Total minutes of active use per week (minutes/week) |
From enrollment to the end of treatment at 24 Weeks
|
|
Safety of Amblyofix
時間枠：From enrollment to the end of treatment at 24 Weeks
|
Safety will be evaluated by recording all adverse events (AEs) and serious adverse events (SAEs) throughout the 24-week intervention period. Particular attention will be paid to ocular health, including reports of visual discomfort, diplopia, or any unexpected effects potentially related to digital therapy or occlusion. All safety data will be reviewed and summarized by the study investigators at each follow-up visit and at study completion. Unit of Measure: Number of participants with adverse events. |
From enrollment to the end of treatment at 24 Weeks
|
協力者と研究者
協力者
協力者
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
その他の研究ID番号
- AFX-PCT-EG-2025
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?
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
米国FDA規制機器製品の研究
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