Comparing Myopia Control Spectacle Lenses and Standard Single Vision Spectacle Lenses in Children With Myopia (PEARL)
A Paired-Eye Comparison of Myopia Control Lenses in Myopic Children
The purpose of this clinical trial is to compare a new myopia control spectacle lens with a standard single vision spectacle lens in slowing the progression of myopia (nearsightedness) in healthy children aged 6 to under 11 years.
The main question being studied is:
Is the new myopia control spectacle lens more effective than a standard single vision spectacle lens in slowing myopia progression?
In this study, participants will wear a myopia control spectacle lens in one eye and a standard single vision spectacle lens in the other eye for the first 6 months. The lens assignment will then be switched between eyes for the remaining 6 months. Researchers will compare changes in eye axial length and refractive error between the two lens types.
Participants will:
- Wear the study spectacles for 12 months.
- Attend scheduled follow-up visits at the Essilor R&D Centre, Singapore.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Thomas Boudenne
- メール:thomas.boudenne@essilor.com
研究連絡先のバックアップ
- 名前:Celine Carimalo
- 電話番号:+65 67134617
- メール:carimalc@essilor.com.sg
研究場所
-
-
-
Singapore、シンガポール
- Essilor R&D Centre Singapore
-
コンタクト:
- Celine Carimalo
- 電話番号:+65 67134617
- メール:carimalc@essilor.com.sg
-
-
参加基準
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:
- Volunteer participant with the willingness and ability to comply with all scheduled study visits.
- Informed consent of parent/guardian and assent of participant.
- Age equal to or greater than 6 years and less than 11 years (before 11th birthday) at the time of consent.
- Spherical equivalent refraction (SER) equal or less than -0.50 D and equal or greater than -4.75D with astigmatism not more than 2.00 D.
- Difference in SER (anisometropia) between two eyes should not exceed 1.00 D.
- Best corrected Distance Visual Acuity (BCDVA) better than or equal to +0.10 LogMAR under high contrast in each eye.
- Be in good general health, based on the participant and the parent's/guardian's knowledge.
- Agree to wear the study spectacles for 12 hours per day and 7 days per week.
- Agree not to be involved in other myopia control treatments.
Exclusion Criteria:
- History of Atropine, Orthokeratology, Myopia Control 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.
- Current or anticipated use of growth hormones.
- 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
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:クロスオーバー割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:OD: SVL; OS: MCL then OD: MCL; OS: SVL
Participants will wear the investigational myopia control spectacle lens in the left eye and a standard single vision spectacle lens in the right eye for the first 6 months. After 6 months, the lens assignment will be switched, with each eye wearing the opposite lens type for another 6 months. |
A spectacle lens designed to help slow the progression of myopia in children A standard spectacle lens used to correct refractive error without a specific myopia control feature |
|
実験的:OD: MCL; OS: SVL then OD: SVL; OS: MCL
Participants will wear the investigational myopia control spectacle lens in the right eye and a standard single vision spectacle lens in the left eye for the first 6 months. After 6 months, the lens assignment will be switched, with each eye wearing the opposite lens type for another 6 months. |
A spectacle lens designed to help slow the progression of myopia in children A standard spectacle lens used to correct refractive error without a specific myopia control feature |
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 |
時間枠 |
|---|---|
|
Change in Eye Axial Length
時間枠:From baseline to 6 months
|
From baseline to 6 months
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change in Eye Axial Length
時間枠:From 6 months to 12 months
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From 6 months to 12 months
|
|
Change in Eye Non-Cycloplegic Spherical Equivalent Refraction
時間枠:From baseline to 6 months
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From baseline to 6 months
|
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Change in Eye Non-Cycloplegic Spherical Equivalent Refraction
時間枠:From 6 months to 12 months
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From 6 months to 12 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Andrew Tan、Essilor R&D Centre Singapore
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
詳しくは
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