Cornea and Laser Eye Institute (S.A.G., A.S.Y., J.D.G., S.H., P.S.H.); CLEI Center for Keratoconus, Teaneck, NJ; and Department of Ophthalmology (S.A.G., J.D.G., P.S.H.), Rutgers New Jersey Medical School, Newark, NJ.
Eye Contact Lens. 2023 Oct 1;49(10):411-416. doi: 10.1097/ICL.0000000000001018. Epub 2023 Aug 8.
To report on the topographic and visual outcomes 10 years after corneal cross-linking in patients with progressive keratoconus and corneal ectasia after refractive surgery.
Cross-sectional cohort study of an original, prospective, randomized, clinical trial. Patients treated in a single center cornea and refractive surgery practice as part of the U.S. pivotal trials, which led to the Food and Drug Administration approval of corneal cross-linking, were recruited for a 10-year follow-up examination. LogMar lines (LL) of uncorrected visual acuity (UCVA) and best spectacle--corrected visual acuity (BSCVA), maximum keratometry, and thinnest pachymetry were evaluated. In addition, the Belin ABCD progression display was used to determine progression (95% confidence interval) of the anterior curvature, posterior curvature, and corneal thickness of each individual eye included.
Nineteen eyes of 13 patients treated with standard cross-linking returned for a 10-year follow-up examination. Mean maximum keratometry changed from 58.2±12.0 diopters (D) to 58.3±10.1 D, thinnest pachymetry changed from 440.6±51.6 µm to 442.3±54.4 μm, UCVA changed from 0.79±0.42 LL to 0.86±0.46 LL, and BSCVA changed from 0.38±0.26 LL to 0.33±0.34 LL, 10 years after cross-linking. Individually, 68.5% of the entire cohort, 81.8% of keratoconus eyes, and 50% of eyes with corneal ectasia remained topographically stable 10 years after standard cross-linking.
In the entire cohort, visual acuity and topography remained stable 10 years after cross-linking. Over the long-term, eyes with keratoconus seem to be more stable than those with corneal ectasia.
报告在接受屈光手术后进行性圆锥角膜和角膜扩张的患者中,角膜交联治疗 10 年后的 topography 和视觉结果。
这是一项原始的、前瞻性、随机、临床试验的病例对照研究。患者在单中心角膜和屈光手术实践中接受治疗,该中心是美国关键试验的一部分,这些试验导致了食品和药物管理局批准的角膜交联治疗,这些患者被招募进行 10 年随访检查。评估未矫正视力(UCVA)和最佳矫正视力(BCVA)、最大角膜曲率和最薄角膜厚度的 LogMar 线(LL)。此外,还使用 Belin ABCD 进展显示来确定每个纳入眼的前曲率、后曲率和角膜厚度的进展(95%置信区间)。
13 名患者的 19 只眼接受了标准交联治疗,并返回进行了 10 年的随访检查。平均最大角膜曲率从 58.2±12.0 屈光度(D)变为 58.3±10.1 D,最薄角膜厚度从 440.6±51.6 µm 变为 442.3±54.4 µm,UCVA 从 0.79±0.42 LL 变为 0.86±0.46 LL,BCVA 从 0.38±0.26 LL 变为 0.33±0.34 LL,交联治疗 10 年后。单独来看,整个队列的 68.5%、圆锥角膜眼的 81.8%和角膜扩张眼的 50%在标准交联治疗 10 年后仍保持 topography 稳定。
在整个队列中,视力和 topography 在交联治疗 10 年后保持稳定。从长远来看,圆锥角膜眼似乎比角膜扩张眼更稳定。