Department of Ophthalmology, Beijing Key Laboratory of Restoration of Damaged Ocular Nerve, Peking University Third Hospital, Beijing, China.
Institute of Medical Technology, Peking University Health Science Center, 49 North Garden Road, Haidian District, Beijing, 100191, China.
BMC Ophthalmol. 2024 Jan 22;24(1):28. doi: 10.1186/s12886-024-03294-z.
The management of post-refractive surgery dry eye disease (DED) can be challenging in clinical practice, and patients usually show an incomplete response to traditional artificial tears, especially when it is complicated with ocular pain. Therefore, we aim to investigate the efficacy of combined topical 0.05% cyclosporine A and 0.1% sodium hyaluronate treatment in post-refractive surgery DED patients with ocular pain unresponsive to traditional artificial tears.
We enrolled 30 patients with post-refractive surgery DED with ocular pain who were unresponsive to traditional artificial tears. Topical 0.05% cyclosporine A and 0.1% sodium hyaluronate were used for 3 months. They were evaluated at baseline and 1 and 3 months for dry eye and ocular pain symptoms and objective parameters, including Numerical Rating Scale (NRS), Neuropathic Pain Symptom Inventory modified for the Eye (NPSI-Eye), tear break-up time (TBUT), Schirmer I test (SIt), corneal fluorescein staining (CFS), corneal sensitivity, and corneal nerve morphology. In addition, tear levels of inflammatory cytokines and neuropeptides were measured using the Luminex assay.
After 3 months of treatment, patients showed a statistically significant improvement in the ocular surface disease index (OSDI), TBUT, SIt, CFS, and corneal sensitivity (all P < 0.01) using linear mixed models. As for ocular pain parameters, the NRS and NPSI-Eye scores were significantly reduced (both P < 0.05) and positively correlated with the OSDI and CFS scores. Additionally, tear IL-1β, IL-6, and TNF-α levels were improved better than pre-treatment (P = 0.01, 0.03, 0.02, respectively).
In patients with post-refractive surgery DED with ocular pain, combined topical 0.05% cyclosporine A and 0.1% sodium hyaluronate treatment improved tear film stability, dry eye discomfort, and ocular pain, effectively controlling ocular inflammation.
Registration number: NCT06043908.
屈光手术后干眼（DED）的管理在临床实践中具有挑战性，患者通常对传统人工泪液的反应不完全，尤其是当伴有眼部疼痛时。因此，我们旨在研究联合应用 0.05%环孢素 A 和 0.1%透明质酸钠治疗对传统人工泪液治疗反应不佳的屈光手术后 DED 伴眼部疼痛患者的疗效。
我们纳入了 30 例对传统人工泪液治疗反应不佳的屈光手术后 DED 伴眼部疼痛患者。给予患者联合应用 0.05%环孢素 A 和 0.1%透明质酸钠治疗 3 个月。在基线、治疗 1 个月和 3 个月时评估干眼和眼部疼痛症状及客观参数，包括数值评分量表（NRS）、改良眼部神经病理性疼痛症状量表（NPSI-Eye）、泪膜破裂时间（TBUT）、泪液分泌试验（SIt）、角膜荧光素染色（CFS）、角膜知觉和角膜神经形态。此外，采用 Luminex 检测法测量泪液中炎症细胞因子和神经肽水平。
线性混合模型分析显示，治疗 3 个月后，患者的眼表面疾病指数（OSDI）、TBUT、SIt、CFS 和角膜知觉显著改善（均 P<0.01）。对于眼部疼痛参数，NRS 和 NPSI-Eye 评分显著降低（均 P<0.05），与 OSDI 和 CFS 评分呈正相关。此外，泪液中白细胞介素-1β（IL-1β）、IL-6 和肿瘤坏死因子-α（TNF-α）水平的改善优于治疗前（P=0.01、0.03、0.02）。
对于屈光手术后 DED 伴眼部疼痛患者，联合应用 0.05%环孢素 A 和 0.1%透明质酸钠治疗可改善泪膜稳定性、干眼不适和眼部疼痛，有效控制眼部炎症。
NCT06043908。
