Musallam Ismail M
Musallam Eye Center of Jerusalem, Beit Hanina, Jerusalem, Israel.
Int J Retina Vitreous. 2025 Jul 1;11(1):73. doi: 10.1186/s40942-025-00699-w.
To evaluate the safety and efficacy of ophthalmic nerve stimulation (ONS), combined with ascorbic acid (AA) in the treatment of retinitis pigmentosa (RP).
Forty participants with RP were enrolled in a prospective open-label single-armed intervention. Patients with non-syndromic RP; aged ≥ 4 years, with BCVA ≥ 20/400 were included. All participants were treated with bilateral ONS sessions combined with intravenous administration of AA for two weeks. The primary efficiency endpoint was the change in scotopic vision at 6 months, assessed using 10-item, 100-point, Low Luminance Questionnaire (LLQ-10). The secondary efficiency points included BCVA and contrast sensitivity. Rod responders were defined by ≥ 25 points increment of LLQ-10 score at 6 months' visit.
Ocular neuromodulation therapy significantly improved low luminance vision, BCVA, and contrast sensitivity in patients with RP (p ≤ 0.05). At 6-month visits, 60% of patients were identified as rod responders. The mean change in LLQ-10 score was (46.35 ± 16.81 point) in rod responders versus (4.9 ± 7.6 point) in non-responders (p < 0.0001). A clinically significant improvement of BCVA (≥ 0.2 logMAR unit) and contrast sensitivity (≥ 0.3 log unit) were demonstrated in 50% of the right eyes of rod responders.
Ocular neuromodulation significantly improved night vision, BCVA, and contrast sensitivity. Determinants of rod responders include the duration of night blindness, stage of the disease, and thickness of ganglion cell layer at baseline. Two therapeutic scenarios were recognized; an early disease-modifying intervention that restores night vision and a late cone rescue intervention that improves/maintains central vision.
评估眼神经刺激（ONS）联合抗坏血酸（AA）治疗视网膜色素变性（RP）的安全性和有效性。
40例RP患者纳入一项前瞻性开放标签单臂干预研究。纳入非综合征性RP患者；年龄≥4岁，最佳矫正视力（BCVA）≥20/400。所有参与者接受双侧ONS治疗，并静脉注射AA，为期两周。主要疗效终点是6个月时暗视觉的变化，采用10项、100分的低亮度问卷（LLQ - 10）进行评估。次要疗效指标包括BCVA和对比敏感度。杆状细胞反应者定义为6个月随访时LLQ - 10评分增加≥25分。
眼神经调节疗法显著改善了RP患者的低亮度视力、BCVA和对比敏感度（p≤0.05）。在6个月随访时，60%的患者被确定为杆状细胞反应者。杆状细胞反应者的LLQ - 10评分平均变化为（46.35±16.81分），而非反应者为（4.9±7.6分）（p<0.0001）。50%的杆状细胞反应者右眼的BCVA（≥0.2 logMAR单位）和对比敏感度（≥0.3 log单位）有临床显著改善。
眼神经调节显著改善了夜视力、BCVA和对比敏感度。杆状细胞反应者的决定因素包括夜盲持续时间、疾病阶段和基线时神经节细胞层厚度。确定了两种治疗方案；一种是恢复夜视力的早期疾病改善干预，另一种是改善/维持中心视力的晚期视锥细胞挽救干预。
