Wei Hongyu, Thakur Sahil, Zhu Qin, Zhou Yanrong, Cao Xuejun, Xiao Shuyuan, Chen Qin, Hu Min, Zhong Hua
Department of Ophthalmology, the First Affiliated Hospital of Kunming Medical University, 295 Xichang Road, Kunming 650032, Yunnan, PR China.
Department of Ocular Epidemiology, Singapore Eye Research Institute, 20 College Road, Singapore 169856, Singapore.
Photodiagnosis Photodyn Ther. 2025 Aug;54:104651. doi: 10.1016/j.pdpdt.2025.104651. Epub 2025 May 29.
To evaluate how choroidal thickness (CT) and choriocapillaris flow deficit density (CCD) change within 6000 µm of the macula following repeated low-level red-light (RLRL) therapy, and to assess whether early choroidal alterations can predict long-term myopia control.
This is a secondary analysis of a prospective randomized controlled trial. Two hundred children with spherical equivalent refraction (SER) of -6.00D to +0.50D were randomized to receive either twice-daily RLRL therapy or no additional intervention (control). Axial length (AL), cycloplegic SER, CT, and CCD were measured at the baseline and at 1, 3, 6 and 12 months.
Baseline characteristics were similar between groups. In the RLRL group, subfoveal choroidal thickness (SFCT) increased progressively over time, reaching its maximum at 12 months; by contrast, SFCT declined in controls. Within the 6000 µm macular zone, CT rose in the RLRL group but fell uniformly in the control group. Improvements on choriocapillaris blood flow were evident at 3 months post-RLRL, yet these changes were not sustained and did not correlate with longer-term choroidal thickening. A prediction model using only the "6-month SFCT change" demonstrated comparable accuracy for forecasting satisfactory myopia control at 12 months to more complex multivariable models.
RLRL therapy induces a marked and sustained thickening of the macular choroid within 6000 µm, while its effects on choriocapillaris perfusion are transient. Moreover, the magnitude of SFCT increase at 6 months alone provides a reliable early predictor of 12-month myopia control efficacy. Trial Registration This trial was registered at the Chinese Clinical Trial Registry on January 30, 2021, with trial registration number: ChiCTR2100042836. https://www.chictr.org.cn/showprojEN.html?proj=120971.
评估重复低强度红光（RLRL）治疗后黄斑区6000 µm范围内脉络膜厚度（CT）和脉络膜毛细血管血流缺失密度（CCD）如何变化，并评估早期脉络膜改变是否能预测长期近视控制效果。
这是一项前瞻性随机对照试验的二次分析。200名等效球镜度（SER）为-6.00D至+0.50D的儿童被随机分为两组，一组接受每日两次的RLRL治疗，另一组不进行额外干预（对照组）。在基线以及第1、3、6和12个月时测量眼轴长度（AL）、睫状肌麻痹下的SER、CT和CCD。
两组的基线特征相似。在RLRL组中，黄斑中心凹下脉络膜厚度（SFCT）随时间逐渐增加，在12个月时达到最大值；相比之下，对照组的SFCT下降。在6000 µm的黄斑区内，RLRL组的CT上升，而对照组则均匀下降。RLRL治疗后3个月时脉络膜毛细血管血流有明显改善，但这些变化未持续，且与长期脉络膜增厚无关。仅使用“6个月时SFCT变化”的预测模型在预测12个月时良好的近视控制效果方面，与更复杂的多变量模型具有相当的准确性。
RLRL治疗可在6000 µm范围内诱导黄斑脉络膜显著且持续增厚，而其对脉络膜毛细血管灌注的影响是短暂的。此外，仅6个月时SFCT增加的幅度就能可靠地早期预测12个月时的近视控制效果。试验注册 本试验于2021年1月30日在中国临床试验注册中心注册，试验注册号：ChiCTR2100042836。https://www.chictr.org.cn/showprojEN.html?proj=120971。
