Department of Ophthalmology, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts.
Departments of Anesthesiology and Surgery, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts.
J AAPOS. 2021 Aug;25(4):217.e1-217.e6. doi: 10.1016/j.jaapos.2021.03.008. Epub 2021 Jul 8.
To evaluate the best-corrected visual acuity and stereoacuity gains in children >7 years of age and adults with unilateral amblyopia treated with a prototype virtual reality-based binocular amblyopia therapy.
In this randomized, double masked, cross-in clinical trial, patients at Boston Children's Hospital with unilateral anisometropic and/or strabismic amblyopia and history of prior amblyopia treatment failure were randomized to either a full-treatment group (8 weeks of binocular treatment using therapeutic software application in virtual reality headset) or a sham-crossover group (4 weeks of sham treatment followed by 4 weeks of binocular treatment). Amblyopic eye visual acuity and stereoacuity were evaluated at 4, 8, and 16 weeks' follow-up.
The study cohort included 20 participants (10 females), with a median age of 9 years (range, 7-38 years). In the full-treatment group (11 patients), the mean amblyopic eye logMAR visual acuity at 16 weeks was 0.49 ± 0.26, compared with 0.47 ± 0.20 at baseline. In the sham-crossover group, it was 0.51 ± 0.18 at 16 weeks, compared with 0.53 ± 0.21 at baseline. Stereoacuity (log arcsec) was significantly improved, from 7.3 ± 2 at baseline to 6.6 ± 2.3 at 8 weeks (P < 0.001) and 6.7 ± 2.6 at 16 weeks (P < 0.001). No significant adverse events (diplopia, asthenopia, or worsening strabismus) were noted in either group.
Although the virtual reality-based prototype for binocular amblyopia therapy did not significantly improve visual acuity in the amblyopic eyes of older children and adults, stereoacuity did significantly improve compared with baseline; improvements were clinically minute. However, larger studies are required to confirm the results.
评估 7 岁以上单眼弱视儿童和成人使用虚拟现实为基础的双眼弱视治疗原型设备治疗后的最佳矫正视力和立体视锐度增益。
在这项随机、双盲、交叉临床试验中,波士顿儿童医院患有单眼屈光不正性和/或斜视性弱视且既往弱视治疗失败的患者被随机分为全治疗组(8 周使用治疗软件的双眼治疗虚拟现实头戴式设备)或假治疗组(4 周假治疗后 4 周双眼治疗)。在 4、8 和 16 周随访时评估弱视眼视力和立体视锐度。
研究队列包括 20 名参与者(10 名女性),中位年龄为 9 岁(范围为 7-38 岁)。在全治疗组(11 名患者)中,16 周时弱视眼对数视力的平均 logMAR 视力为 0.49 ± 0.26,基线时为 0.47 ± 0.20。在假治疗组中,16 周时为 0.51 ± 0.18,基线时为 0.53 ± 0.21。立体视锐度(log 弧秒)显著改善,从基线时的 7.3 ± 2 提高到 8 周时的 6.6 ± 2.3(P < 0.001)和 16 周时的 6.7 ± 2.6(P < 0.001)。两组均未出现明显不良事件(复视、视疲劳或斜视恶化)。
虽然虚拟现实为基础的双眼弱视治疗原型设备并没有显著提高大龄儿童和成人弱视眼的视力,但与基线相比,立体视锐度确实有显著提高;改善程度在临床上微不足道。然而,需要更大的研究来证实这些结果。