Kelly Krista R, Jost Reed M, Dao Lori, Beauchamp Cynthia L, Leffler Joel N, Birch Eileen E
Retina Foundation of the Southwest, Dallas, Texas.
ABC Eyes Pediatric Ophthalmology, PA, Dallas, Texas.
JAMA Ophthalmol. 2016 Dec 1;134(12):1402-1408. doi: 10.1001/jamaophthalmol.2016.4224.
Fellow eye patching has long been the standard treatment for amblyopia, but it does not always restore 20/20 vision or teach the eyes to work together. Amblyopia can be treated with binocular games that rebalance contrast between the eyes so that a child may overcome suppression. However, it is unclear whether binocular treatment is comparable to patching in treating amblyopia.
To assess the effectiveness of a binocular iPad (Apple Inc) adventure game as amblyopia treatment and compare this binocular treatment with patching, the current standard of care.
DESIGN, SETTING, AND PARTICIPANTS: This investigation was a randomized clinical trial with a crossover design at a nonprofit eye research institute. Between February 20, 2015, and January 4, 2016, a total of 28 patients were enrolled in the study, with 14 randomized to binocular game treatment and 14 to patching treatment.
Binocular game and patching as amblyopia treatments.
The primary outcome was change in amblyopic eye best-corrected visual acuity (BCVA) at the 2-week visit. Secondary outcomes were change in stereoacuity and suppression at the 2-week visit and change in BCVA at the 4-week visit.
Among 28 children, the mean (SD) age at baseline was 6.7 (1.4) years (age range, 4.6-9.5 years), and 7 (25%) were female. At baseline, the mean (SD) amblyopic eye BCVA was 0.48 (0.14) logMAR (approximately 20/63; range, 0.3-0.8 logMAR [20/40 to 20/125]), with 14 children randomized to the binocular game and 14 to patching for 2 weeks. At the 2-week visit, improvement in amblyopic eye BCVA was greater with the binocular game compared with patching, with a mean (SD) improvement of 0.15 (0.08) logMAR (mean [SD], 1.5 [0.8] lines) vs 0.07 (0.08) logMAR (mean [SD], 0.7 [0.8] line; P = .02) after 2 weeks of treatment. These improvements from baseline were significant for the binocular game (mean [SD] improvement, 1.5 [0.8] lines; P < .001) and for patching (mean [SD] improvement, 0.7 [0.8] line; P = .006). Depth of suppression improved from baseline at the 2-week visit for the binocular game (mean [SD], 4.82 [2.82] vs 3.24 [2.87]; P = .03) and for patching (mean [SD], 4.77 [3.10] vs 2.57 [1.67]; P = .004). Patching children crossed over to binocular game treatment, and all 28 children played the game for another 2 weeks. At the 4-week visit, no group difference was found in BCVA change, with children who crossed over to the binocular games catching up with children treated with binocular games, for a mean (SD) improvement of 0.17 (0.10) logMAR (mean [SD], 1.7 [1.0] lines) for the binocular game vs a mean (SD) improvement of 0.16 (0.12) logMAR (mean [SD], 1.6 [1.2] lines) for the patching crossover (P = .73).
A binocular iPad game was effective in treating childhood amblyopia and was more efficacious than patching at the 2-week visit. Binocular games that rebalance contrast to overcome suppression are a promising additional option for treating amblyopia.
clinicaltrials.gov Identifier: NCT02365090.
长期以来，单眼遮盖一直是弱视的标准治疗方法，但它并不总能恢复20/20的视力，也无法教会双眼协同工作。弱视可以通过双眼游戏进行治疗，这种游戏能重新平衡双眼之间的对比度，从而使儿童克服抑制。然而，目前尚不清楚双眼治疗与遮盖治疗弱视的效果是否相当。
评估一款双目iPad（苹果公司）冒险游戏作为弱视治疗方法的有效性，并将这种双眼治疗方法与当前的标准治疗方法——遮盖法进行比较。
设计、地点和参与者：本研究是一项在非营利性眼科研究所进行的交叉设计随机临床试验。2015年2月20日至2016年1月4日期间，共有28名患者参与研究，其中14名随机接受双眼游戏治疗，14名接受遮盖治疗。
采用双眼游戏和遮盖法治疗弱视。
主要结局是在2周随访时弱视眼最佳矫正视力（BCVA）的变化。次要结局是2周随访时立体视锐度和抑制的变化，以及4周随访时BCVA的变化。
28名儿童中，基线时的平均（标准差）年龄为6.7（1.4）岁（年龄范围4.6 - 9.5岁），7名（25%）为女性。基线时，弱视眼BCVA的平均（标准差）为0.48（0.14）logMAR（约20/63；范围0.3 - 0.8 logMAR [20/40至20/125]），14名儿童随机接受双眼游戏治疗，14名接受遮盖治疗2周。在2周随访时，与遮盖法相比，双眼游戏使弱视眼BCVA的改善更大，治疗2周后，平均（标准差）改善为0.15（0.08）logMAR（平均[标准差]，1.5 [0.8]行），而遮盖法为0.07（0.08）logMAR（平均[标准差]，0.7 [0.8]行；P = 0.02）。与基线相比，双眼游戏（平均[标准差]改善，1.5 [0.8]行；P < 0.001）和遮盖法（平均[标准差]改善，0.7 [0.8]行；P = 0.006）的这些改善均具有统计学意义。在2周随访时，双眼游戏组和遮盖法组的抑制深度均较基线有所改善（双眼游戏组：平均[标准差]，4.82 [2.82]对3.24 [2.87]；P = 0.03；遮盖法组：平均[标准差]，4.77 [3.10]对2.57 [1.67]；P = 0.004）。接受遮盖治疗的儿童转而接受双眼游戏治疗，所有28名儿童又玩了2周游戏。在4周随访时，未发现两组在BCVA变化方面存在差异，转而接受双眼游戏治疗的儿童赶上了接受双眼游戏治疗的儿童，双眼游戏组平均（标准差）改善0.17（0.10）logMAR（平均[标准差]，1.7 [1.0]行），遮盖法交叉组平均（标准差）改善0.16（0.12）logMAR（平均[标准差]，1.6 [1.2]行）（P = 0.73）。
一款双目iPad游戏对治疗儿童弱视有效，且在2周随访时比遮盖法更有效。通过重新平衡对比度以克服抑制的双眼游戏是治疗弱视的一种有前景的额外选择。
clinicaltrials.gov标识符：NCT02365090
