重复低强度红光疗法对高度近视儿童轴向缩短的影响：多中心随机对照试验。

IF 4.1 1区医学 Q1 OPHTHALMOLOGY

American Journal of Ophthalmology Pub Date : 2024-10-16 DOI:10.1016/j.ajo.2024.10.011

Guihua Liu , Lin Liu , Hua Rong , Li Li , Xuan Liu , Zhiyang Jia , Hua Zhang , Biying Wang , Desheng Song , Jiamei Hu , Xinrui Shi , Bei Du , Ruihua Wei

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引用次数: 0

摘要

目的评估RLRL在延缓高度近视-6.00 D或更差的进展方面的有效性和安全性。设计多中心、随机、平行组、单盲临床试验。参与者2022年3月至2022年12月期间，2202名7至12岁的高度近视儿童入组，他们的球面等效屈光度（SE）≤-6.00 D，散光小于2.50 D，异视小于或等于1.50 D。方法将符合条件的参与者随机分配到干预组（RLRL + 单光眼镜 [SVS]）或对照组（SVS）。RLRL治疗每天进行两次，每次3分钟，每次间隔至少4小时。主要结果测量主要结果是12个月时轴向长度（AL）与基线相比的变化。次要结果包括 SE 的变化、脉络膜厚度 (ChT) 和不同圆周视网膜厚度 (RT) 的变化。结果治疗12个月后，RLRL组的AL和SE分别为-0.11 ± 0.25 mm和0.18 ± 0.63 D，对照组分别为0.32 ± 0.09 mm和-0.80 ± 0.42 D。在 12 个月时，观察到 RLRL 组轴向缩短 > 0.05 mm 的比例为 59%，对照组为 0%。对一个中心的 ChT 和 RT 进行了分析。12 个月时，RLRL 组所有区段的 ChT 都增厚了。视网膜旁和视网膜周围的 RT 增加。在对照组中，12 个月时所有区段的 ChT 和仅眼底周围的 RT 都明显变薄。多变量线性回归模型显示，1 个月时 ChT 中央眼窝圆和 RT 眼周圆的变化与 12 个月时 AL 的变化之间存在明显的相关性。没有眼底结构变化、超过 6 分钟的残像或最佳矫正视力下降的报告。在 12 个月的治疗过程中，AL 的缩短是持续性的。这些观察到的变化似乎与ChT和RT的增加有关。

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Axial Shortening Effects of Repeated Low-level Red-light Therapy in Children With High Myopia: A Multicenter Randomized Controlled Trial

PURPOSE

To evaluate the effectiveness and safety of repeated low-level red-light (RLRL) in delaying the progression of high myopes with –6.00 diopters (D) or worse.

DESIGN

Multicenter, randomized, parallel-group, single-blind clinical trial. A total of 202 high myopic children aged 7 to 12 years with cycloplegia spherical equivalent (SE) refraction ≤–6.00 D, astigmatism less than 2.50 D, and anisometropia of 1.50 D or less were enrolled from March 2022 to December 2022. Follow-up was completed in December 2023.

METHODS

Eligible participants were randomly allocated to the intervention (RLRL + single vision spectacle) or the control group (single vision spectacle). The RLRL treatment was administered every day for 3 minutes, twice a day, with an interval of at least 4 hours. The primary outcome was the change in axial length (AL) at 12 months compared with baseline. Secondary outcomes included changes in SE, changes in choroidal thickness (ChT), and changes in retinal thickness (RT) in different circle sectors. Outcomes were analyzed by means of intention-to-treat and per-protocol methods.

RESULTS

After 12 months of treatment, AL and SE changes were –0.11 ± 0.25 mm and 0.18 ± 0.63 D for the RLRL group and 0.32 ± 0.09 mm and –0.80 ± 0.42 D for the control group, respectively. Axial shortening >0.05 mm was 59% in the RLRL and 0% in the control group at 12 months. ChT and RT from a single center were analyzed. In the RLRL group, ChT was thickened in all sectors at 12 months. RT was increased in parafoveal and perifoveal circles. In the control group, all sectors of ChT and only perifoveal RT were significantly thinner at 12 months. The multivariate linear regression model revealed significant correlations between changes in the ChT central foveal circle and RT perifoveal circle at 1 month and AL changes at 12 months. No fundus structure changes, afterimage exceeding 6 minutes, or best-corrected visual acuity decrease were reported.

CONCLUSIONS

RLRL could effectively shorten the AL and inhibit the progression of myopia in high myopic patients with –6.00 D or worse. AL shortening is sustained over 12 months of treatment. These observed changes appeared to be associated with increases in ChT and RT.

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来源期刊

American Journal of Ophthalmology 医学-眼科学

CiteScore

9.20

自引率

7.10%

发文量

406

审稿时长

36 days

期刊介绍： The American Journal of Ophthalmology is a peer-reviewed, scientific publication that welcomes the submission of original, previously unpublished manuscripts directed to ophthalmologists and visual science specialists describing clinical investigations, clinical observations, and clinically relevant laboratory investigations. Published monthly since 1884, the full text of the American Journal of Ophthalmology and supplementary material are also presented online at www.AJO.com and on ScienceDirect. The American Journal of Ophthalmology publishes Full-Length Articles, Perspectives, Editorials, Correspondences, Books Reports and Announcements. Brief Reports and Case Reports are no longer published. We recommend submitting Brief Reports and Case Reports to our companion publication, the American Journal of Ophthalmology Case Reports. Manuscripts are accepted with the understanding that they have not been and will not be published elsewhere substantially in any format, and that there are no ethical problems with the content or data collection. Authors may be requested to produce the data upon which the manuscript is based and to answer expeditiously any questions about the manuscript or its authors.