The Ohio State University College of Optometry, Columbus, Ohio.
Optom Vis Sci. 2020 Sep;97(9):690-696. doi: 10.1097/OPX.0000000000001559.
Midday fogging of scleral contact lenses requires frequent lens removal and reapplication for a large portion of lens wearers. Using a lens filling solution that mimics the composition of tears is hypothesized to have an impact on the production of material trapped under a scleral lens.
The purposes of this open-label study were to assess the safety of a scleral lens filling solution, which closely approximates the ionic concentration and pH of human tears, and to assess signs and symptoms of midday fogging with this formulation and with subjects' habitual sodium chloride solutions.
Existing scleral lens wearers with midday fogging (N = 22) were examined and completed surveys of symptoms. Subjects filled the concavity of their current lenses with test solution and were assessed immediately and approximately 4 hours later for safety monitoring. Test solution was dispensed and used for 5 to 9 days when subjects were reexamined and repeated the surveys. Biomicroscopy and anterior optical coherence tomography images were used to assess midday fogging objectively.
The median (interquartile range) Ocular Surface Disease Index score decreased from 27.1 (21.7) U when using habitual filling solution to 9.1 (20.1) U when using the test solution (P = .006). Current Symptoms Survey findings with the test solution compared with habitual solution resulted in statistically significant decreases in burning/stinging (P = .04), grittiness/foreign body sensation (P = .01), dryness (P = .002), blurry/fluctuating vision (P = .002), and overall pain/discomfort (P = .006). Objective assessment of corneal staining and fogging revealed decreases that were not statistically significant in this small sample size.
This study establishes the safety and subject tolerance of a scleral lens filling solution that mimics the ionic composition of human tears. Significant improvements in subjective ratings, although likely biased in this unmasked trial, suggest that further studies of the effectiveness of this solution in reducing midday fogging are warranted.
对于大部分角膜接触镜佩戴者来说,需要频繁地摘下和重新戴上日抛型巩膜隐形眼镜,以应对中午时分的镜片起雾问题。使用一种模仿泪液成分的镜片填充液,据推测会对被困在巩膜镜片下的物质的产生产生影响。
本开放性标签研究的目的是评估一种与人类泪液的离子浓度和 pH 值非常接近的巩膜隐形眼镜填充液的安全性,并评估使用该配方和受试者惯用的氯化钠溶液时中午起雾的迹象和症状。
对有中午起雾问题的现有巩膜隐形眼镜佩戴者(N=22)进行检查并完成症状调查。受试者将测试溶液填充到他们当前镜片的凹面中,立即和大约 4 小时后进行安全性监测评估。当受试者再次接受检查并重复调查时,会分配和使用测试溶液 5 至 9 天。使用生物显微镜和前光学相干断层扫描图像对中午起雾问题进行客观评估。
使用惯用填充液时,眼表面疾病指数评分中位数(四分位距)为 27.1(21.7)U,而使用测试溶液时为 9.1(20.1)U(P=0.006)。与惯用溶液相比,使用测试溶液的当前症状调查结果显示,烧灼感/刺痛感(P=0.04)、砂砾感/异物感(P=0.01)、干燥感(P=0.002)、模糊/波动的视力(P=0.002)和整体疼痛/不适(P=0.006)显著降低。在这个小样本量中,角膜染色和起雾的客观评估显示出无统计学意义的下降。
本研究确立了模仿人类泪液离子组成的巩膜隐形眼镜填充液的安全性和受试者耐受性。尽管在这项非盲试验中可能存在偏倚,但主观评分的显著改善表明,进一步研究这种溶液在减少中午起雾方面的有效性是合理的。