Randomized clinical trial comparing customized corneal crosslinking: epi-on in high oxygen and epi-off in room air for keratoconus.

IF 2.6 3区 医学 Q2 OPHTHALMOLOGY Journal of cataract and refractive surgery Pub Date : 2024-07-01 DOI:10.1097/j.jcrs.0000000000001442
Sofie Elving, Anneli Fredriksson, Jeannette Beckman Rehnman, Anders Behndig
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Abstract

Purpose: To compare clinical outcomes of customized transepithelial (epi-on) corneal crosslinking (CXL) in high oxygen and customized CXL with epithelial removal (epi-off) in room air for keratoconus (KC).

Setting: Umeå University Hospital, Umeå, Sweden.

Design: Prospective, randomized, single-masked, intraindividually comparing study.

Methods: 32 participants with bilateral progressive KC were treated with bilateral customized topography-guided CXL, 30 mW/cm 2 ; 7.2 to 15 J/cm 2 and were randomized to epi-on in one eye (32 eyes) and epi-off in the fellow eye (32 eyes). Uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA), maximal keratometry (Kmax), subjective ocular discomfort, low-contrast visual acuities (LCVAs) at 10% and 2.5% contrast, ocular and anterior corneal wavefront aberrations, manifest refractive spherical equivalent, endothelial cell count (ECC), and adverse events were assessed through 24 months.

Results: Both treatments showed improvements at 24 months in UDVA; -0.16 ± 0.24 ( P < .001) and -0.13 ± 0.20 logMAR ( P = .006), respectively, CDVA; -0.10 ± 0.11 ( P < .001) and -0.10 ± 0.12 ( P = .001), Kmax; -1.74 ± 1.31 ( P < .001) and -1.72 ± 1.36 D ( P < .001). LCVA 10% improved for both protocols ( P < .001), but LCVA 2.5% improved for epi-on CXL only ( P = .001). ECC was unaltered, and no adverse events occurred. The epi-on eyes had significantly less discomfort symptoms during the whole first week posttreatment ( P < .05).

Conclusions: High-oxygen customized epi-on CXL is a viable alternative to room air customized epi-off CXL, with faster improvements in CDVA and LCVA and less early ocular discomfort.

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比较定制角膜交联术的随机临床试验:角膜塑形镜在高氧条件下使用外显子和在室内空气中使用外显子的比较。
目的:比较在高氧条件下定制的经上皮角膜交联(epi-on)和在室内空气中定制的上皮去除角膜交联(epi-off)对角膜炎(KC)的临床疗效:瑞典于默奥,于默奥大学医院:前瞻性、随机、单掩蔽、个体内部比较研究:32名患有双侧进行性KC的患者接受了双侧定制地形图引导的CXL治疗,治疗剂量为30 mW/cm2; 7.2-15 J/cm2。对未矫正视力(UDVA)和最佳矫正视力(BCVA)、最大角膜度数(Kmax)、眼部主观不适感、10% 和 2.5% 对比度下的低对比度视力(LCVA)、眼部和角膜前波前像差、显性屈光球面等值(MRSE)、内皮细胞计数(ECC)和不良反应进行了为期 24 个月的评估:两种治疗方法在24个月后均有改善,UDVA分别为-0.16 ± 0.24(p < 0.001)和-0.13 ± 0.20 logMAR(p = 0.006),BCVA分别为-0.10 ± 0.11(p < 0.001)和-0.10 ± 0.12(p = 0.001),Kmax分别为-1.74 ± 1.31(p < 0.001)和-1.72 ± 1.36 D(p < 0.001)。两种方案的LCVA均提高了10%(p < 0.001),但仅Epi-on CXL的LCVA提高了2.5%(p = 0.001)。ECC未发生变化,也未出现不良反应。在治疗后的整个第一周内,外显子眼睛的不适症状明显减少(p < 0.05):结论:高氧定制外显子 CXL 是室内空气定制外显子 CXL 的可行替代方案,能更快地改善 BCVA 和 LCVA,减少早期眼部不适。
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来源期刊
CiteScore
5.60
自引率
14.30%
发文量
259
审稿时长
8.5 weeks
期刊介绍: The Journal of Cataract & Refractive Surgery (JCRS), a preeminent peer-reviewed monthly ophthalmology publication, is the official journal of the American Society of Cataract and Refractive Surgery (ASCRS) and the European Society of Cataract and Refractive Surgeons (ESCRS). JCRS publishes high quality articles on all aspects of anterior segment surgery. In addition to original clinical studies, the journal features a consultation section, practical techniques, important cases, and reviews as well as basic science articles.
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