仮想現実ゲームによる新しい弱視治療
二視視、視差誘導、手と目の協調強化、本格的な仮想現実ゲームによる新しい弱視治療
The goal of this study is to compare the change in amblyopic eye acuity between treatment periods in children with amblyopia, aged 5-17 years. The main question it aims to answer is:
Is a 16-week course of amblyopia treatment using Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for approx. 25 min/day, 6 days/week more effective for improvement in amblyopic-eye VA, binocularity (stereoacuity, suppression, alignment), contrast sensitivity, attention, oculomotor function, visual-motor integration, and quality of life than 16 weeks of continued glasses alone?
Participants will each serve as their own control and complete:
Treatment period 1: Continued optical correction (glasses) alone for 16 weeks; Treatment period 2: Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for 16 weeks (approx. 25min/day, 6 days/week) plus continued optical correction
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Ohio
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Columbus、Ohio、アメリカ、43210
- The Ohio State University College of Optometry
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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:
Patients ages 5 to 17 years of age
- Moderate to severe unilateral amblyopia (logMAR best corrected visual acuity 0.3 to 1.3) associated with anisometropia and/or strabismus of ≤5pd
- Age normal VA in the nonamblyopic eye
- Spectacle correction (if required) worn for at least 16 weeks, or until stability of VA is demonstrated (<0.1 logMAR change by the same testing method measured on 2 exams at least 8 weeks apart)
- Interocular difference of ≥ 3 lines
- No amblyopia treatment in the past 2 weeks
- An interpupillary distance of 52-72 mm (inclusive)
Exclusion Criteria:
- Myopia greater than -6.00 diopters (D) spherical equivalent in either eye.
- Previous intraocular or refractive surgery.
- Previous dichoptic treatment > 2 weeks in duration
- Ocular co-morbidity that may reduce visual acuity determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the participant if the above visual acuity criteria are met).
- Diplopia more than once per week over the last week prior to enrollment by parental report.
- Down syndrome or cerebral palsy.
- Light-induced seizures
- Known simulator sickness
- Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and/or learning disabilities are not excluded.
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：非ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Optical Correction alone
Optical correction alone (16 weeks) (Each participant will complete both study conditions.) |
Optical correction (if needed) |
|
実験的：Therapeutic (Dichoptic) Virtual Reality Games plus Continued Optical Correction
Therapeutic (Dichoptic) Virtual Reality Games plus continued optical correction (16 weeks) (Each participant will complete both study conditions.) |
Optical correction (if needed) Virtual Reality Game play for amblyopia treatment |
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 |
|---|---|---|
|
Difference in Mean Change in Amblyopic Eye Visual Acuity
時間枠：Baseline to 16 weeks versus 16 weeks to 32 weeks
|
Optical correction worn for testing using Amblyopia Treatment Study (ATS) protocol; HOTV for ages 5-6 years; E-ETDRS for ages 7 years and older |
Baseline to 16 weeks versus 16 weeks to 32 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Difference in Change in Stereoacuity/Binocularity
時間枠：Baseline to 16 weeks versus 16 weeks to 32 weeks
|
Optical correction worn for testing. Stereoacuity scores (seconds of arc) calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) tests. Lower scores indicate better stereoacuity. Nil (4000) defined as an incorrect response (or lack of an attempt) on the butterfly without a correct response on 800 seconds of arc level of Randot Preschool stereoacuity test. Stereoacuity scores will be ordered and assigned a rank score. Change in stereoacuity will be calculated as the difference in change in ranked score. |
Baseline to 16 weeks versus 16 weeks to 32 weeks
|
|
Difference in Mean Change in Amblyopic-Eye Contrast Sensitivity
時間枠：Baseline to 16 weeks versus 16 weeks to 32 weeks
|
Optical correction worn for testing. Spot Checks;Contrast sensitivity scores range from unable (<0.90), and then from 0.90 to 2.05 (by 0.05 log contrast sensitivity units). |
Baseline to 16 weeks versus 16 weeks to 32 weeks
|
|
Difference in Mean Change in Attention
時間枠：Baseline to 16 weeks versus 16 weeks to 32 weeks
|
Optical correction worn for testing. The Children's Color Trails Test (CCTT) is a neuropsychological standardized test that measures attention, divided attention, and speed of mental processing. |
Baseline to 16 weeks versus 16 weeks to 32 weeks
|
|
Difference in Mean Change in reading eye movements
時間枠：Baseline to 16 weeks versus 16 weeks to 32 weeks
|
Optical correction worn for testing with Readalyzer eye tracker. |
Baseline to 16 weeks versus 16 weeks to 32 weeks
|
|
Difference in Mean Change in visual-motor integration
時間枠：Baseline to 16 weeks versus 16 weeks to 32 weeks
|
Optical correction worn for testing. Beery Visual-Motor Integration; standard scores with mean of 100, standard deviation of 15 |
Baseline to 16 weeks versus 16 weeks to 32 weeks
|
|
Difference in Mean Change in Pediatric Eye Questionnaire (PedEyeQ)
時間枠：Baseline to 16 weeks versus 16 weeks to 32 weeks
|
Pediatric Eye Questionnaire (PedEyeQ) domain score; scores for questionnaire items will be obtained from published look-up tables available at www.pedig.net; scaled to score from 0 to 100 (worst to best) |
Baseline to 16 weeks versus 16 weeks to 32 weeks
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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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