Travé-Huarte Sònia, Wolffsohn James S
Optometry and Vision Science Research Group, College of Health and Life Sciences, Aston University, Birmingham, UK.
Clin Ophthalmol. 2024 May 13;18:1329-1339. doi: 10.2147/OPTH.S458715. eCollection 2024.
To assess changes in symptoms and ocular surface signs following a bilateral sutureless treatment of dehydrated amniotic membrane (dAM) under a specialised bandage contact lens (sBCL) in patients with moderate-to-severe dry eye disease (DED).
In this prospective pre-post interventional study, 35 patients diagnosed with moderate-to-severe DED, with an Ocular Surface Disease Index (OSDI) score >30 on current treatment, were enrolled. Assessments were conducted at baseline (day -30), after 30 days run-in with no additional treatment (day 0 - control), and 30 days post sBCL+dAM treatment (day 30 - treatment). Intervention involved two successive bilateral 4-5 day sutureless applications of dAM (17mm diameter, with a 6 mm central aperture, Omnigen VIEW) under an 18mm sBCL (OmniLenz). Symptomatology and ocular signs were measured using OSDI, Dry Eye Questionnaire-5 (DEQ-5), Symptom Assessment iN Dry Eye (SANDE), and other ocular surface health indicators including non-invasive breakup time, corneal and conjunctival staining, and lid wiper epitheliopathy length and width (LWE).
While symptomatology remained stable during the 30-day no-treatment run-in, 1-month post-dAM treatment, there was a significant reduction in OSDI scores (from 55.8 to 32.3, p<0.001), DEQ-5 (from 14.6 to 10.0, p<0.001), SANDE frequency (from 65.2 to 43.6, p<0.001), and SANDE severity (from 59.8 to 41.1, p<0.001). Additionally, there was a notable decrease in the width of LWE staining, from grade 2 (50-75% of the lid wiper) to grade 1 (25-50% of the lid wiper) (p=0.011).
A bilateral 8-10-day treatment duration with dAM applied with sBCL demonstrated a 31 to 42% improvement in symptomatology and a decrease in ocular surface signs of mechanical stress. This innovative bilateral treatment approach offers a promising treatment modality for patients with refractory moderate-to-severe DED.
评估在中度至重度干眼疾病（DED）患者中，采用特殊绷带式隐形眼镜（sBCL）进行双侧无缝脱水羊膜（dAM）治疗后症状和眼表体征的变化。
在这项前瞻性干预前后研究中，纳入了35例被诊断为中度至重度DED的患者，其当前治疗下的眼表疾病指数（OSDI）评分>30。在基线（第-30天）、30天无额外治疗的导入期后（第0天 - 对照）以及sBCL + dAM治疗后30天（第30天 - 治疗）进行评估。干预包括在18mm的sBCL（OmniLenz）下连续两次双侧无缝应用dAM（直径17mm，中央孔径6mm，Omnigen VIEW），每次应用4 - 5天。使用OSDI、干眼问卷-5（DEQ-5）、干眼症状评估（SANDE）以及其他眼表健康指标（包括非侵入性泪膜破裂时间、角膜和结膜染色以及睑板腺上皮病变的长度和宽度（LWE））来测量症状和眼部体征。
在30天的无治疗导入期内症状保持稳定，但在dAM治疗1个月后，OSDI评分显著降低（从55.8降至32.3，p<0.001），DEQ-５评分（从14.6降至10.0，p<0.001），SANDE频率（从65.2降至43.6，p<0.001）以及SANDE严重程度（从59.8降至41.1，p<0.001）。此外，LWE染色宽度显著减小，从2级（睑板腺的50 - 75%）降至1级（睑板腺的25 - 50%）（p = 0.011）。
采用sBCL应用dAM进行双侧8 - 10天的治疗，症状改善了31%至42%，眼表机械应力体征减少。这种创新的双侧治疗方法为难治性中度至重度DED患者提供了一种有前景的治疗方式。
