Central Florida Eye Specialists, 968 International Parkway, Lake Mary, FL, 32746, USA.
Int Ophthalmol. 2023 Aug;43(8):2737-2747. doi: 10.1007/s10792-023-02673-7. Epub 2023 Mar 10.
To quantitatively assess postoperative rotational stability and visual acuity with the DFT/DATx15 extended depth of focus (EDOF) toric intraocular lens (IOL).
In this prospective case series, thirty-five patients with a calculated IOL power between + 15.0 D and + 25.0 D, corneal astigmatism between 0.75 D and 2.25 D, and no significant ocular pathology underwent cataract surgery. Primary outcome was rotational stability of the IOL at 1 month post-operatively. Secondary outcomes included residual refractive astigmatism, absolute residual astigmatism prediction error, and monocular distance and intermediate visual acuities.
Mean absolute postoperative IOL rotation was 1.1 ± 0.2 degrees, with no rotation of more than 3 degrees at the final visit. Monocular mean best spectacle-corrected distance visual acuity (BSCDVA) improved from logMAR 0.27 ± 0.030 to 0.078 ± 0.017 (P < .001). Monocular uncorrected distance visual acuity (UCDVA) improved from 0.93 ± 0.096 to 0.18 ± 0.022 (P < .001). Best spectacle-corrected intermediate visual acuity (DSCIVA) was 0.17 ± 0.025, and uncorrected intermediate visual acuity (UCIVA) was 0.27 ± 0.040. Residual regular astigmatic refractive error was 0.21 ± 0.047 D.
The toric DFT/DATx15 EDOF lens showed excellent rotational stability and effective and predictable correction of astigmatism. Its refractive outcomes and safety profile were similar to those identified in prior studies of the non-toric DFT/DAT015 EDOF IOL. A small difference in monocular BSCDVA, of uncertain clinical significance, was found when comparing these outcomes with prior DFT/DAT015 data. The trial was retrospectively registered on November 5, 2021 (TRN NCT05119127).
定量评估 DFT/DATx15 扩展景深（EDOF）散光矫正型人工晶状体（IOL）术后的旋转稳定性和视力。
本前瞻性病例系列研究纳入了 35 例计算 IOL 度数在+15.0D 至+25.0D 之间、角膜散光在 0.75D 至 2.25D 之间、且无明显眼部病变的患者，均接受白内障手术。主要结局为术后 1 个月时 IOL 的旋转稳定性。次要结局包括残余屈光性散光、绝对残余散光预测误差以及单眼远距和中距视力。
平均术后 IOL 旋转角度为 1.1±0.2 度，末次随访时无超过 3 度的旋转。单眼最佳矫正远视力（BSCDVA）从 logMAR 0.27±0.030 提高至 0.078±0.017（P<0.001）。单眼未矫正远视力（UCDVA）从 0.93±0.096 提高至 0.18±0.022（P<0.001）。最佳矫正中距视力（DSCIVA）为 0.17±0.025，未矫正中距视力（UCIVA）为 0.27±0.040。残余规则性散光屈光度为 0.21±0.047D。
散光 DFT/DATx15 EDOF 人工晶状体具有良好的旋转稳定性，能够有效、准确地矫正散光。其屈光结果和安全性与先前非散光 DFT/DAT015 EDOF IOL 的研究结果相似。与先前 DFT/DAT015 数据相比，发现单眼 BSCDVA 略有差异（不确定是否具有临床意义）。该试验于 2021 年 11 月 5 日（TRN NCT05119127）进行了回顾性注册。
