Department of Ophthalmology, Uludag University, Bursa, Turkey,
Ophthalmol Ther. 2015 Jun;4(1):21-32. doi: 10.1007/s40123-015-0032-4. Epub 2015 Mar 31.
The aim of this study was to assess distance, intermediate, and near visual acuity, contrast sensitivity, and patient satisfaction outcomes of a multifocal intraocular lens (IOL).
This multicenter, prospective clinical study was conducted at seven study sites in Turkey. Patients who underwent bilateral cataract removal and implantation of a diffractive, acrylic, hydrophobic, multifocal IOL (Acriva UD Reviol MFB 625; VSY Biotechnology, Istanbul, Turkey) were included. The uncorrected and best corrected distance visual acuities (UCDVA and BCDVA), uncorrected and best corrected intermediate visual acuities (UCIVA and BCIVA), and uncorrected and best corrected near visual acuities (UCNVA and BCNVA) were measured preoperatively and at postoperative 1, 6, and 12 months. Distance and near visual acuity scores (VAS) contrast sensitivities were measured at these time points. Quality of life was evaluated by visual function-14 (VF-14) questionnaire.
Two hundred eyes of 100 patients were included. Monocular and binocular visual acuities at all distances showed improvement at postoperative 12 months compared to preoperative measurements (P < 0.001). Monocular and binocular UCIVA and binocular BCIVA at postoperative 12 months were significantly improved compared to measurements at 1 month (P < 0.001). Binocular contrast sensitivity at distance showed significant improvement from postoperative 1 month to postoperative 12 months, except for 3 cycles per degree (cpd; without glare) and 18 cpd (with glare). VAS improved from 75.96 at postoperative 1 month to 76.85 at postoperative 12 months. VF-14 score was 98.2 ± 4.6.
The Acriva UD Reviol MFB 625 appears to provide a good level of distance and near visual acuity, quality of life, and patient satisfaction. Further studies with longer follow-up will provide valuable insight into the long-term stability of these visual outcomes.
本研究旨在评估一种多焦点人工晶状体(IOL)的远、中、近视力、对比敏感度和患者满意度结果。
这是一项在土耳其七个研究地点进行的多中心、前瞻性临床研究。纳入了接受双侧白内障切除和植入折射、丙烯酸、疏水性、多焦点 IOL(Acriva UD Reviol MFB 625;VSY 生物技术,伊斯坦布尔,土耳其)的患者。在术前和术后 1、6 和 12 个月分别测量了未矫正和最佳矫正远视力(UCDVA 和 BCDVA)、未矫正和最佳矫正中间视力(UCIVA 和 BCIVA)以及未矫正和最佳矫正近视力(UCNVA 和 BCNVA)。在这些时间点测量了距离和近视力评分(VAS)对比敏感度。通过视觉功能-14(VF-14)问卷评估生活质量。
纳入了 100 名患者的 200 只眼。与术前测量相比,术后 12 个月单眼和双眼在所有距离的视力均有所提高(P < 0.001)。与术后 1 个月相比,术后 12 个月单眼和双眼 UCIVA 和双眼 BCIVA 均有显著改善(P < 0.001)。术后 1 个月至术后 12 个月,双眼远距对比敏感度显著提高,除 3 周/度(无眩光)和 18 周/度(有眩光)外。VAS 从术后 1 个月的 75.96 提高到术后 12 个月的 76.85。VF-14 评分为 98.2 ± 4.6。
Acriva UD Reviol MFB 625 似乎提供了良好的远、近视力、生活质量和患者满意度。进一步的长期随访研究将提供这些视觉结果长期稳定性的有价值的见解。