Sánchez-González José-María, Sánchez-González María Carmen, De-Hita-Cantalejo Concepción, Nascimento Henrique, Martinez-Perez Clara
Department of Physics of Condensed Matter, Optics Area, University of Seville, Seville, Spain.
ISEC LISBOA-Instituto Superior de Educação e Ciências, Lisbon, Portugal.
Ophthalmol Ther. 2025 Jul 17. doi: 10.1007/s40123-025-01205-z.
To evaluate the immediate effects of two artificial tear formulations-mineral oil + hydroxypropyl guar (HP-Guar) and hyaluronic acid (HA) + HP-Guar-on ocular aberrations in healthy participants.
A randomized, participant-masked clinical trial was conducted on 98 right eyes of 98 participants (mean age: 27.96 ± 10.00 years). Participants received a single instillation of either a lipid-based (mineral oil + HP-Guar) or non-lipid (HA + HP-Guar) artificial tear solution. Ocular aberrations were measured before and 10 min post-instillation using a wavefront aberrometer (i.Profilerplus, Carl Zeiss Meditec, Jena, Germany) at pupil diameters of 3 mm and 5 mm. Root mean square (RMS) values for total, low-order, and high-order aberrations were analyzed.
The mineral oil + HP-Guar formulation significantly reduced total RMS (p < 0.05) and low-order RMS (p < 0.05) at both 3-mm and 5-mm pupil diameters. Notable reductions were observed in defocus (Z), vertical astigmatism (Z), and trefoil (Z). Both formulations significantly increased high-order RMS (p < 0.05).
Lipid-based artificial tears provide superior optical quality by reducing total and low-order ocular aberrations, making them preferable for patients with tear film instability. In contrast, HA-based formulations primarily improve hydration with limited impact on optical performance. Artificial tear selection should consider both symptomatic relief and refractive stability, especially for individuals with high visual demands.
This study was registered as a randomized clinical trial on ClinicalTrials.gov under the identifier NCT06784661, titled the ILEACT study.
评估两种人工泪液制剂——矿物油+羟丙基瓜尔胶（HP-瓜尔胶）和透明质酸（HA）+HP-瓜尔胶——对健康受试者眼部像差的即时影响。
对98名受试者（平均年龄：27.96±10.00岁）的98只右眼进行了一项随机、受试者盲法的临床试验。受试者单次滴注脂质基（矿物油+HP-瓜尔胶）或非脂质（HA+HP-瓜尔胶）人工泪液。使用波前像差仪（i.Profilerplus，卡尔蔡司医疗技术公司，德国耶拿）在3毫米和5毫米瞳孔直径下，于滴注前和滴注后10分钟测量眼部像差。分析了总像差、低阶像差和高阶像差的均方根（RMS）值。
矿物油+HP-瓜尔胶制剂在3毫米和5毫米瞳孔直径下均显著降低了总RMS（p<0.05）和低阶RMS（p<0.05）。在散焦（Z）、垂直散光（Z）和三叶草像差（Z）方面观察到显著降低。两种制剂均显著增加了高阶RMS（p<0.05）。
脂质基人工泪液通过减少总像差和低阶眼部像差提供了更好的光学质量，使其更适合泪膜不稳定的患者。相比之下，HA基制剂主要改善水合作用，对光学性能的影响有限。人工泪液的选择应同时考虑症状缓解和屈光稳定性，特别是对于有高视觉需求的个体。
本研究在ClinicalTrials.gov上注册为一项随机临床试验，标识符为NCT06784661，标题为ILEACT研究。
