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角膜交联和角膜内环段治疗圆锥角膜:同期与序贯手术的随机研究。

Corneal crosslinking and intracorneal ring segments for keratoconus: A randomized study of concurrent versus sequential surgery.

机构信息

Cornea and Laser Eye Institute-Hersh Vision Group, CLEI Center for Keratoconus, Teaneck, New Jersey, USA; Department of Ophthalmology, Rutgers-New Jersey Medical School, Newark, New Jersey, USA.

Cornea and Laser Eye Institute-Hersh Vision Group, CLEI Center for Keratoconus, Teaneck, New Jersey, USA; Department of Ophthalmology, Rutgers-New Jersey Medical School, Newark, New Jersey, USA.

出版信息

J Cataract Refract Surg. 2019 Jun;45(6):830-839. doi: 10.1016/j.jcrs.2019.01.020. Epub 2019 Mar 27.

DOI:10.1016/j.jcrs.2019.01.020
PMID:30928252
Abstract

PURPOSE

To assess outcomes of corneal crosslinking (CXL) and intracorneal ring segments (ICRS) (Intacs) used adjunctively, and then compare the safety and efficacy of concurrent versus sequential surgery.

SETTING

Cornea and refractive surgery subspecialty practice.

DESIGN

Prospective randomized clinical trial.

METHODS

Patients were randomized to one of two groups: ICRS first, immediately followed by CXL during the same session (n = 104), or ICRS followed by CXL 3 months later (n = 94). Outcomes included changes in maximum keratometry (K) and topographic inferior-superior (I-S) difference, maximum flattening of topographic K, and changes in uncorrected (UDVA) and corrected (CDVA) distance visual acuities. These were analyzed in the entire cohort, in the two randomized groups, and in subgroups stratified to ICRS size and placement. Patients were followed for 6 months.

RESULTS

The study comprised 198 eyes of 198 patients. Overall, maximum K decreased by an average of 2.5 D, I-S difference improved by 3.9 D, and there was an average maximum flattening of -7.5 D. The UDVA improved by 2.0 logarithm of the minimum angle of resolution lines, on average, and the CDVA improved by 1.1 lines. There was no significant difference between the sequential and concurrent groups in any of the outcomes analyzed. There were 6 clinically significant adverse events.

CONCLUSIONS

CXL and ICRS can be used adjunctively with substantial improvement in corneal topography, and with no increase in safety concerns over each procedure alone. Sequential and concurrent treatment with ICRS and CXL show equivalent outcomes. Both thicker segment size and single segment placement seem to result in greater topographic improvement.

摘要

目的

评估角膜交联(CXL)和角膜内环段(ICRS)(Intacs)联合应用的结果,然后比较同期与序贯手术的安全性和疗效。

设置

角膜和屈光手术亚专科。

设计

前瞻性随机临床试验。

方法

患者随机分为两组之一:ICRS 先行,在同一手术中立即行 CXL(n=104),或 ICRS 后 3 个月行 CXL(n=94)。结果包括最大角膜曲率(K)和地形下-上(I-S)差值、最大地形 K 平坦度和未矫正(UDVA)和矫正(CDVA)远视力的变化。这些在整个队列、两个随机组和按 ICRS 大小和位置分层的亚组中进行分析。患者随访 6 个月。

结果

该研究包括 198 例 198 只眼。总体而言,最大 K 值平均降低 2.5 D,I-S 差值改善 3.9 D,最大平坦度平均降低-7.5 D。UDVA 平均提高 2.0 个最小分辨角对数线,CDVA 平均提高 1.1 行。在分析的所有结果中,序贯组和同期组之间没有显著差异。有 6 例临床显著不良事件。

结论

CXL 和 ICRS 可联合应用,显著改善角膜地形,且每种手术的安全性担忧均无增加。ICRS 和 CXL 的序贯和同期治疗结果相当。较厚的片段大小和单片段放置似乎都能导致更好的地形改善。

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