Department of Ophthalmology, Grampian University Hospitals-NHS Trust Aberdeen, Scotland, United Kingdom.
Retina. 2011 Jun;31(6):1122-7. doi: 10.1097/IAE.0b013e3182003adb.
The purpose of this study was to evaluate "in vivo" safety of trypan blue (TB) in patients undergoing TB-assisted internal limiting membrane or epiretinal membrane peeling.
Prospective study including 21 patients (21 eyes) with full-thickness macular hole and/or epiretinal membrane undergoing TB-assisted internal limiting membrane/epiretinal membrane peeling. Main outcome measures included distance visual acuity, near visual acuity, amplitude of P50 and N95 of the pattern electroretinogram, and fundus autofluorescence; these were assessed preoperatively, at 6 months (n = 21) and 12 months (n = 10) postoperatively.
There was a statistically significant improvement in distance visual acuity, near visual acuity, P50, and N95 amplitude at 6 months and 12 months postoperatively. The mean logarithm of the minimum angle of resolution distance visual acuity and near visual acuity improved from baseline by 0.31 (SD 0.37) and 0.17 (SD 0.31) at 6 months, respectively, and by 0.4 (SD 0.25) and 0.35 (SD 0.28) at 12 months, respectively. The mean P50 and N95 component amplitudes improved by 28% compared with baseline at 6 months (P50 0.4 [SD 0.8]; N95 0.53 [SD 1.07]) and by 63% at 12 months (P50 0.9 [0.85]; N95 1.04 [1.34]). Autofluorescence did not demonstrate damage to the retinal pigment epithelium attributable to TB.
No deleterious effects of TB were observed in this study.
本研究旨在评估曲安奈德(TB)在接受 TB 辅助性内界膜或视网膜内界膜剥除术的患者中的“体内”安全性。
前瞻性研究纳入 21 例(21 只眼)全层黄斑裂孔和/或视网膜内界膜前膜患者,均接受 TB 辅助性内界膜/视网膜内界膜剥除术。主要观察指标包括远视力、近视力、图形视网膜电图 P50 和 N95 波振幅,以及眼底自发荧光;所有患者分别于术前、术后 6 个月(n = 21)和 12 个月(n = 10)进行评估。
术后 6 个月和 12 个月时,远视力、近视力、P50 和 N95 波振幅均有显著提高。术后 6 个月时,平均最小分辨角对数视力和近视力分别较基线提高 0.31(标准差 0.37)和 0.17(标准差 0.31),术后 12 个月时分别提高 0.4(标准差 0.25)和 0.35(标准差 0.28)。术后 6 个月时,P50 和 N95 波振幅分别较基线提高 28%(P50 0.4[标准差 0.8];N95 0.53[标准差 1.07]),术后 12 个月时分别提高 63%(P50 0.9[0.85];N95 1.04[1.34])。眼底自发荧光未显示 TB 导致视网膜色素上皮损伤。
本研究未观察到 TB 的有害作用。