Data for: Performance of corneal vs. scleral rigid gas permeable contact lenses for ectatic corneal disorders

Introduction. Keratoconus and related corneal ectatic disorders are typically managed with corneal rigid gas permeable contact lenses (CRGPcl). When these are unsuccessful patients may be fitted with scleral rigid gas permeable contact lenses (SRGPcl). It has been hypothesised that the use of SRGPcl in the management of ectatic corneal disorders should be expanded and SRGPcl may even considered as the first option. The present research investigates this hypothesis. Purpose. To compare the performance of CRGPcl versus SRGPcl in participants with keratoconus, who are successfully wearing “habitual” CRGPcl. Methods. RCT) with a 2x2 crossover, 34 participants were recruited. The outcome measures were: Early Treatment Diabetic Retinopathy (ETDRS) log of minimum angle of resolution (logMAR) best corrected visual acuity (BCVA); VectorVision 1000E contrast sensitivity function (CSF), expressed in both numeric and log contrast sensitivity (logCS); National Eye Institute Visual Function Questioannaire-25 (NEI-VFQ) to assess the visual Qol; and reported o a scale from 1–10, the Levit Subjective Vision Scores (LSVS) and the Levit Subjective Comfort Scores (LSCS). The final outcome was the selection of the preferred lens type at research completion. Results. The only measures, which exhibited statistically significant differences between the two lens types, rejecting H0, were the LSCS, which was significantly higher in SRGPcl (p=0.002). The LSCS whilst wearing the experimental CRGPcl, was significantly higher in participants who selected CRGPcl [N=16, (52%)] as their preferred lens for future use, compared to those who selected SRGPcl (p=0.009). All other outcomes supported H0. The Final lens choice: CRGPcl were preferred by 53% (n=16) and SRGPcl by 47% (n=14). Conclusion. The research population exhibited significantly better comfort in SRGPcl compared with CRGPcl. Significantly higher comfort in CRGPcl was found in those who preferred CRGPcl, than those who preferred SRGPcl. Furthermore, Successful CRGPcl wearers whose LSCS in CRGPcl is < 7 are likely to achieve better comfort / tolerance with SRGPcl. This research indicates that on average, successful CRGPcl wearers find SRGPcl more comfortable and there should be no visual and visual Qol advantage or disadvantage in refitting successful keratoconic CRGPcl wearers with SRGPcl and vice versa.引言 圆锥角膜（Keratoconus）及相关角膜扩张性疾病的临床管理通常采用硬性透气性接触镜（corneal rigid gas permeable contact lenses, CRGPcl）。若此类镜片无法满足治疗需求，则可通过验配巩膜硬性透气性接触镜（scleral rigid gas permeable contact lenses, SRGPcl）进行干预。已有假说提出，应扩大SRGPcl在角膜扩张性疾病管理中的应用范围，甚至可将其作为首选治疗方案。本研究旨在验证该假说。 研究目的 比较已成功佩戴“常规”硬性透气性接触镜的圆锥角膜受试者，使用CRGPcl与SRGPcl的临床效果。 研究方法 本研究采用2×2交叉设计的随机对照试验（randomized controlled trial, RCT），共招募34名受试者。研究的结局指标包括：早期糖尿病视网膜病变研究（Early Treatment Diabetic Retinopathy, ETDRS）最小分辨角对数（logMAR）最佳矫正视力（best corrected visual acuity, BCVA）；VectorVision 1000E对比敏感度函数（contrast sensitivity function, CSF），以数值及对数对比敏感度（log contrast sensitivity, logCS）两种形式报告；美国国家眼科研究所视觉功能问卷-25（National Eye Institute Visual Function Questionnaire-25, NEI-VFQ）用于评估视觉生活质量；以及采用1~10分量表的莱维特主观视力评分（Levit Subjective Vision Scores, LSVS）与莱维特主观舒适度评分（Levit Subjective Comfort Scores, LSCS）。本研究的最终结局为研究结束时受试者对镜片类型的偏好选择。 研究结果 仅莱维特主观舒适度评分（LSCS）在两种镜片类型间存在统计学显著差异，从而拒绝原假设H0：SRGPcl组的LSCS评分显著更高（p=0.002）。在选择CRGPcl作为未来首选镜片的受试者（n=16，占比52%）中，佩戴试验用CRGPcl时的LSCS评分显著高于选择SRGPcl作为首选镜片的受试者（p=0.009）。其余所有结局指标均支持原假设H0。最终镜片选择偏好：53%（n=16）的受试者偏好CRGPcl，47%（n=14）的受试者偏好SRGPcl。 研究结论 本研究人群使用SRGPcl的舒适度显著优于CRGPcl。在偏好CRGPcl的受试者中，其佩戴CRGPcl时的舒适度评分显著高于偏好SRGPcl的受试者。此外，若成功佩戴CRGPcl的受试者在使用CRGPcl时的LSCS评分低于7分，则其使用SRGPcl时可能获得更佳的舒适度与耐受性。本研究表明，平均而言，成功佩戴CRGPcl的受试者会认为SRGPcl更舒适；且为成功适配圆锥角膜的CRGPcl佩戴者更换为SRGPcl，不会对其视力及视觉生活质量产生优劣差异，反之亦然。