Instituto Universitario de Oftalmobiología Aplicada (IOBA), Universidad de Valladolid, Valladolid, Spain; Departamento de Física Teórica, Atómica y Óptica, Universidad de Valladolid, Valladolid, Spain.
Instituto Universitario de Oftalmobiología Aplicada (IOBA), Universidad de Valladolid, Valladolid, Spain.
Cont Lens Anterior Eye. 2021 Aug;44(4):101370. doi: 10.1016/j.clae.2020.09.003. Epub 2020 Oct 16.
To study the effect of daily disposable contact lens (DDCL) refitting in monthly contact lens (CL) wearers suffering from contact lens discomfort (CLD), and to assess if there is a placebo effect associated with this CLD intervention.
Symptomatic CL wearers, according to the Contact Lens Dry Eye Questionnaire 8 (CLDEQ-8 ≥ 12 points), were divided into two groups. The study group was provided with DDCLs (delefilcon A) and the control group with a masked pair of their habitual monthly CLs (placebo effect) and were assessed after one month. Then, the control group was provided with the same DDCLs and evaluated one month later. The symptoms were recorded with the CLDEQ-8 and global rating of change scale (GRCS). Non-invasive tear break-up time (NITBUT), conjunctival hyperaemia, fluorescein staining, and lid wiper epitheliopathy (LWE) were evaluated. Changes between visits, groups, and the effect of each intervention were analysed.
Thirty-one participants (mean age: 23.2 ± 5.3 years) were recruited. The study group (n = 14) showed an improvement of -39.6 ± 25.8 % (p < 0.001) in CLDEQ-8 and 31.3 ± 14.6 points in GRCS (p < 0.001) after one month of DDCL use, while no changes in clinical tests were found. In the control group (n = 17), symptoms improved significantly after wearing the masked monthly CL (CLDEQ-8: -26.1 ± 31.0 %, p = 0.03; GRCS: 14.9 ± 17.0, p = 0.002), however a worsening in bulbar (26.5 ± 40.0 %; p = 0.02) and limbal hyperaemia (21.6 ± 34.7 %, p = 0.02) and an improvement of -19.1 ± 37.0 % (p = 0.049) in LWE was found. When the control group was fitted with the DDCL, improvements in GRCS (20.5 ± 25.5, p = 0.02), NITBUT (37.9 ± 42.3 %, p = 0.002), and conjunctival staining (-47.1 ± 59.9 %, p = 0.005) were noted.
Refitting symptomatic monthly CL wearers with Delefilcon A DDCL is effective in reducing symptoms related to CLD. However, clinicians and researchers must be aware of the existence of a placebo effect when assessing the effectiveness of any CL refitting.
研究日戴型软性接触镜（DDCL）对因接触镜不适（CLD）而佩戴月戴型软性接触镜（CL）的患者的影响，并评估这种 CLD 干预是否存在安慰剂效应。
根据接触镜干眼问卷 8（CLDEQ-8≥12 分），将有症状的 CL 佩戴者分为两组。研究组提供日戴型软性接触镜（德菲康 A），对照组提供其习惯性月戴型软性接触镜的隐形配对（安慰剂效应），并在一个月后进行评估。然后，对照组在一个月后提供相同的 DDCL 并进行评估。使用 CLDEQ-8 和整体变化评分量表（GRCS）记录症状。评估非侵入性泪膜破裂时间（NITBUT）、结膜充血、荧光素染色和睑板腺上皮病（LWE）。分析了就诊间、组间的变化以及每种干预措施的效果。
共招募了 31 名参与者（平均年龄：23.2±5.3 岁）。研究组（n=14）在使用 DDCL 一个月后，CLDEQ-8 改善了-39.6±25.8%（p<0.001），GRCS 改善了 31.3±14.6 分（p<0.001），而临床检查无变化。在对照组（n=17）中，在佩戴隐形月戴型软性接触镜后，症状明显改善（CLDEQ-8：-26.1±31.0%，p=0.03；GRCS：14.9±17.0，p=0.002），但球结膜充血（26.5±40.0%；p=0.02）和角膜缘充血（21.6±34.7%，p=0.02）恶化，LWE 改善-19.1±37.0%（p=0.049）。当对照组佩戴 DDCL 时，GRCS（20.5±25.5，p=0.02）、NITBUT（37.9±42.3%，p=0.002）和结膜染色（-47.1±59.9%，p=0.005）均有改善。
用德菲康 A 日戴型软性接触镜替换有症状的月戴型软性接触镜可有效减轻 CLD 相关症状。然而，当评估任何 CL 替换的有效性时，临床医生和研究人员必须意识到存在安慰剂效应。
