Purpose

To evaluate visual function, ocular surface integrity and dry eye symptoms with an extended depth-of-focus (EDOF) design and a conventional multifocal (MF) contact lens (CL) after 15 days of wear.

Methods

A crossover single mask randomised clinical trial was conducted including 30 presbyopes who used an EDOF and a conventional MF CL (Biofinity MF) for 15 days each. Defocus curves, depth-of-focus range, contrast sensitivity (CS) under photopic and mesopic conditions (with and without glare) and subjective perception of halos and glare were evaluated. The ocular surface was evaluated through non-invasive Keratograph tear breakup time (NIKBUT), averaged tear breakup time (NIKBUT-avg), tear meniscus height (TMH), bulbar and limbal redness, and conjunctival and corneal staining. Dry eye symptoms were assessed with the OSDI questionnaire.

Results

No statistically significant differences were found for defocus curves or depth-of-focus between the two CLs (both p > 0.05). Subjective perception of halos and glare was not significantly different between CLs. Statistically significant differences were observed for CS under mesopic conditions for low spatial frequencies (p = 0.008). None of the CL produced significant changes in NIKBUT, NIKBUT-avg, TMH or redness. No change in conjunctival staining was observed in 76.7 % and 73.3 % of participants for EDOF and Biofinity MF, respectively. No change in corneal staining was observed in 86.7 % and 83.3 % of participants for EDOF and Biofinity MF, respectively. No changes were observed in the symptomatology measured with OSDI questionnaire (p > 0.05).

Conclusions

Both CL for presbyopia offer good visual quality, preserve the ocular surface integrity and provide the patient with similar symptomatology levels after 15 days of lens wear.

中文翻译：

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新型扩展焦深和传统多焦点隐形眼镜的视觉功能、眼表完整性和症状

目的

在佩戴 15 天后，使用扩展焦深 (EDOF) 设计和传统多焦点 (MF) 隐形眼镜 (CL) 评估视觉功能、眼表完整性和干眼症状。

方法

进行了一项交叉单面罩随机临床试验，包括 30 名老花眼，他们分别使用 EDOF 和传统 MF CL（Biofinity MF）15 天。评估了散焦曲线、焦深范围、明视和中视条件（有和没有眩光）下的对比敏感度 (CS) 以及光晕和眩光的主观感知。通过无创角膜曲率计撕裂时间 (NIKBUT)、平均泪液破裂时间 (NIKBUT-avg)、泪液半月板高度 (TMH)、延髓和角膜缘发红以及结膜和角膜染色来评估眼表。使用 OSDI 问卷评估干眼症状。

结果

两个 CL 之间的散焦曲线或焦深没有发现统计学上的显着差异（均 p > 0.05）。光晕和眩光的主观感知在 CL 之间没有显着差异。在低空间频率的中间条件下观察到 CS 的统计学显着差异（p = 0.008）。CL 均未在 NIKBUT、NIKBUT-avg、TMH 或发红方面产生显着变化。在 EDOF 和 Biofinity MF 中，分别有 76.7% 和 73.3% 的参与者未观察到结膜染色的变化。在 EDOF 和 Biofinity MF 中，分别有 86.7% 和 83.3% 的参与者的角膜染色没有变化。使用 OSDI 问卷测量的症状没有观察到变化（p > 0.05）。

结论

用于老花眼的两种 CL 都提供良好的视觉质量，保持眼表完整性，并在佩戴镜片 15 天后为患者提供相似的症状水平。