A 16 Week Randomized, Single-masked, Multicenter Proof of Concept Study of Binocular Videogames Versus Patching for Amblyopia in Children 4-7 Years of Age With an Open-label Substudy of Binocular Videogames in Children 8-12 Years of Age
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 9
- 主要终点
- Change in best corrected visual acuity (BCVA) in the amblyopic eye.
研究概览
简要总结
The purpose of this PoC study was to evaluate the potential therapeutic efficacy of binocular video games played on a tablet and to compare the efficacy of binocular video games versus patching in amblyopic patients 4 to 7 years old (Part A) as well as to gain experience with binocular video games in older children population of 8 to12 years old (Part B).
Part A and Part B was designed to provide long term data on durability of binocular video games treatment.
The study consisted of two parts, Part A: randomized, single masked PoC study in children 4 to 7 years old at Screening, and Part B: open-label substudy in children 8 to 12 year old at Screening.
详细描述
The clinical investigation consisted of 2 parts:
- Part A: a single-masked, randomized clinical investigation in subjects 4 to 7 years of age.
- Part B: an open-label, non-randomized sub-investigation in subjects 8 to 12 years of age.
Part A was a 16-week, prospective, randomized, single-masked, multicenter, controlled, 2 arm, parallel-group clinical investigation in subjects 4 to 7 years of age with amblyopia. Subjects were randomly assigned in a 1:1 ratio to either binocular videogame treatment for 8 to 12 weeks or patching treatment for 16 weeks. Randomization was stratified by severity of amblyopia in eligible subjects (moderate amblyopia with best-corrected visual acuity (BCVA) of the amblyopic eye of 20/100 or better, or severe amblyopia with BCVA of the amblyopic eye worse than 20/100).
Part B was a 16-week, open-label, single arm sub investigation in subjects 8 to 12 years of age with amblyopia, in which selected sites could participate. Subjects received binocular videogame treatment for 8 weeks, followed by 8 weeks of follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Part A: Single-masked by outcome assessor only
Part B: Open-label
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be signed by the parent(s) or legal guardian(s) prior to participation in the study.
- •Male or female children 4 to 7 years old at Screening (Part A) or 8 to 12 years old at Screening (Part B).
- •Diagnosis of amblyopia due to strabismus, anisometropia, or both.
- •Best corrected visual acuity (BCVA) of amblyopic eye (study eye) between 0.3 to 1.0 Logarithm of the Minimum Angle of Resolution (logMAR) (20/40 to 20/200 Snellen inclusive, 33 to 72 ETDRS letters inclusive) at Screening and Baseline.
- •BCVA of the sound eye (fellow eye) 0.1 logMAR (20/25 Snellen, 80 Early Treatment Diabetic Retinopathy Study (ETDRS) letters) or better in children 5 years of age and older or 0.2 logMAR (20/30 Snellen, 75 ETDRS letters) or better in children 4 years of age at Screening and Baseline.
- •Interocular difference of BCVA at least 0.3 logMAR (≥3 lines; ETDRS≥15 letters) at Baseline.
- •Patient is able to play the binocular game (Dig Rush and Monster Burner) on at least level 3 on the study tablet under binocular conditions (with red-green glasses).
排除标准
- •Treatment for amblyopia with patching, Bangerter filter, vision therapy, or binocular treatment in the past 1 week prior to Screening, or atropine in the past 4 weeks prior to Screening.
- •Treatment for amblyopia with patching, Bangerter filter, vision therapy, binocular treatment or atropine for more than 1 year prior to screening cumulatively.
- •Myopia ≥ -6.00D spheric equivalent in either eye at Screening or Baseline.
- •Prior amblyopia treatment (patching, Bangerter filter, vision therapy, binocular treatment or atropine) for more than a year prior to screening cumulatively.
结局指标
主要结局
Change in best corrected visual acuity (BCVA) in the amblyopic eye.
时间窗: from Baseline to Week 8
Part A: Best corrected visual acuity (BCVA) in the amblyopic eye will be measured via mixed model repeated measures (MMRM).
次要结局
- Attain BCVA of 0.1 logMAR or better in the amblyopic eye(at Week 4, Week 8, Week 12, and Week 16.)
- Change in stereoacuity or binocular video game relative to patching.(from Baseline to Week 4, Week 8, Week 12, and Week 16.)
- Change in BCVA in the amblyopic eye(from Baseline to Week 4, Week 12, and Week 16.)
- Time played as recorded in the video game system(from Baseline to week 12)
- Percentage of participants who complete at least 75% of prescribed game play(from Baseline to Week 12)
- Attain a 2-line or better improvement in BCVA in the amblyopic eye(at Week 4, Week 8, Week 12, and Week 16.)
- Time played as recorded in the diary(from Baseline to week 12)
- Time patched as recorded in the diary(from Baseline to week 16)
- Frequency of treatment-emergent Adverse Events(from Baseline to week 16)