Purpose

To compare the comfort and visual performance of corneal rigid gas permeable contact lenses (CoL) and scleral rigid gas permeable contact lenses (SL) in participants with corneal ectasia, successfully wearing “habitual” CoL.

Methods

In a randomised controlled trial (RCT) with a 2 × 2 crossover, 34 participants were recruited and randomised into two groups. Group 1 (sequence AB), were fitted in period 1, with new CoL and after a 4-week washout period, in which habitual CoL were worn, were fitted with and crossed-over to SL, period 2. Group 2 (sequence BA), were first fitted with SL in period 1 and after a washout period of 4 weeks, crossed-over to new CoL, period 2. The median lengths in weeks of Periods 1 and 2 were: 17.5 (IQR 12.4) and 14.5 (IQR 6.2) respectively. The outcome measures for visual performance were best corrected visual acuity and the contrast sensitivity function. Vision related quality of life (Qol) was assessed using the National Eye Institute Visual Function Questioannaire-25 and reported subjective perception of vision (SPV) and reported subjective perception of comfort (SPC) scores, recorded on a scale from 1–10. The final outcome measure was the selection of the preferred lens type at the completion of the RCT.

Results

For the 30 who completed the trial, significantly higher SPC scores were found for SL compared to CoL (p = 0.002). Significantly higher SPC scores for CoL were found in participants who selected CoL as their preferred lens for future use, compared to those who selected SL (p = 0.009). All other outcomes exhibited no significant difference between the experimental lenses. There was no significant difference (p=0.86) in the proportion preferring CoL (53%) and SL (47%).

Conclusion

Significantly better comfort was reported for SL compared with CoL. Significantly higher comfort in CoL was found in those who preferred CoL, than those who preferred SL. Successful CoL wearers whose SPC in CoL is <7 are likely to achieve better comfort with SL. On average, successful CoL wearers found SL more comfortable and there are unlikely to be any significant visual or visual Qol advantage or disadvantage in refitting successful CoL wearers with keratoconus and other corneal ectasia disorders, with SL and vice versa.

中文翻译：

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角膜与巩膜刚性透气性隐形眼镜治疗圆锥角膜和其他扩张性角膜疾病的随机对照试验。

目的

比较角膜刚性透气性隐形眼镜 (CoL) 和巩膜刚性透气性隐形眼镜 (SL) 在成功佩戴“习惯性” CoL 的角膜扩张症参与者中的舒适度和视觉性能。

方法

在一项 2 × 2 交叉的随机对照试验 (RCT) 中，招募了 34 名参与者并随机分为两组。第 1 组（序列 AB）在第 1 阶段安装新的 CoL，并在 4 周的清洗期后，佩戴习惯性 CoL，安装并交叉到第 2 阶段的 SL。第 2 组（序列 BA） )，首先在第 1 阶段安装 SL，在 4 周的清洗期后，交叉到新的 CoL，第 2 阶段。第 1 和第 2 周的中位数长度为：17.5 (IQR 12.4) 和 14.5 (IQR) 6.2) 分别。视觉表现的结果测量是最佳矫正视力和对比敏感度函数。使用 National Eye Institute Visual Function Questioannaire-25 评估与视觉相关的生活质量 (Qol)，并报告主观视觉感知 (SPV) 和报告主观舒适感知 (SPC) 分数，记录在 1-10 的范围内。最终结果衡量标准是在 RCT 完成时选择首选镜片类型。

结果

对于完成试验的 30 人，与 CoL 相比，SL 的 SPC 得分明显更高（p = 0.002）。与选择 SL 的参与者相比，选择 CoL 作为未来使用首选镜片的参与者发现 CoL 的 SPC 得分明显更高（p = 0.009）。所有其他结果在实验镜片之间没有显着差异。偏好 CoL (53%) 和 SL (47%) 的比例没有显着差异 (p=0.86)。

结论

与 CoL 相比，SL 的舒适度显着提高。与喜欢 SL 的人相比，那些喜欢 CoL 的人在 CoL 中的舒适度明显更高。CoL 中 SPC <7 的成功 CoL 佩戴者可能会获得更好的 SL 舒适度。平均而言，成功的 CoL 佩戴者发现 SL 更舒适，并且在使用 SL 对成功的 CoL 佩戴者进行圆锥角膜和其他角膜扩张疾病的改装时，不太可能有任何显着的视觉或视觉 Qol 优势或劣势，反之亦然。