Karandikar Smita, Bhandari Vipul, Reddy Jagdeesh
Nepal J Ophthalmol. 2015 Jul;7(14):164-72. doi: 10.3126/nepjoph.v7i2.14967.
To evaluate the visual outcomes and intraocular pressure changes after Visian Implantable Collamer Lens (ICL) implantation V4b and V4c (with centraflow technology) for correction of myopia.
A prospective, consecutive, comparative interventional case series of V4b and V4c ICL implantation done for correction of high myopia (>-6 diopter D) in patients unsuitable for laser vision correction. The outcome measures that were evaluated included preoperative and postoperative uncorrected distant visual acuity (UDVA), best spectacle corrected distant visual acuity (CDVA), endothelial cell count (ECC), presence of lens opacification, intraocular pressure (IOP) and ICL vaulting. A follow-up of upto 1 year was done. A questionnaire was given at the end of follow-up period.
A total of 30 eyes (24.56±4.8 years) underwent V4b ICL implantation (10 non-toric, 20 toric ICL-TICL) with intraoperative peripheral iridectomy (PI) and 34 eyes (26.13±3.8 years) had implantation of V4c ICL with centraflow (12 non-toric, 22 TICL). The mean preoperative manifest spherical equivalent (MSE) was 8.98±2.8 D and 9.24±2.4 D in the V4b and V4c groups respectively which reduced to postoperative values of -0.28±1.3 D and -0.19±1.18 D respectively. The mean preoperative astigmatism was -1.8±1.2 diopter cylinder (Dcyl) and -1.9±1.6 Dcyl which respectively reduced to -0.8±0.8 Dcyl and -0.9±0.3 Dcyl. At the end of 1 year follow up, mean ECC loss was 7.6% and 7.1%, mean vault was 583.12±231.12 μ and 602±241.24μ respectively in the V4b and V4c groups. Anterior subcapsular opacities were present in 6.66% and 2.94% of eyes with V4b and V4c groups respectively. Two eyes from both V4b (10%) and V4c (8.33%) had rotation of more than 30 degrees and required re-rotation surgery done successfully. Two eyes (6.66%) with V4b ICL implantation had high postoperative IOP (>35 mm Hg) and required Nd:Yag laser iridotomy later done with successful control of IOP. The safety indices were 1.12 and 1.15 and efficacy indices were 1.5 and 1.6 in the V4b and V4c groups respectively at the end of 1 year. The most common visual complaint was glare and haloes in 24% and 27% in the two groups respectively. However, they were not annoying enough to cause visual disability.
Both V4b and V4c Visian ICL implantations are comparable in terms of visual outcome and safety profile for correction of high myopia. However, V4c ICL offers these advantages without the requirement of an additional PI.
评估Visian可植入式角膜接触镜（ICL）V4b和V4c（采用中央流体技术）植入术后的视力结果和眼压变化，用于矫正近视。
这是一项前瞻性、连续性、对比性干预病例系列研究，对不适合激光视力矫正的高度近视（>-6屈光度D）患者进行V4b和V4c ICL植入。评估的结果指标包括术前和术后未矫正远视力（UDVA）、最佳矫正远视力（CDVA）、内皮细胞计数（ECC）、晶状体混浊情况、眼压（IOP）和ICL拱高。随访时间长达1年。随访结束时发放问卷。
共有30只眼（24.56±4.8岁）接受了V4b ICL植入（10只非散光型，20只散光型ICL-TICL）并在术中进行周边虹膜切除术（PI），34只眼（26.13±3.8岁）植入了带中央流体的V4c ICL（12只非散光型，22只TICL）。V4b组和V4c组术前平均等效球镜度（MSE）分别为8.98±2.8 D和9.24±2.4 D，术后分别降至-0.28±1.3 D和-0.19±1.18 D。术前平均散光分别为-1.8±1.2屈光度柱镜（Dcyl）和-1.9±1.6 Dcyl，术后分别降至-0.8±0.8 Dcyl和-0.9±0.3 Dcyl。在1年随访结束时，V4b组和V4c组平均ECC损失分别为7.6%和7.1%，平均拱高分别为583.12±231.12μm和602±241.24μm。V4b组和V4c组分别有6.66%和2.94%的眼出现前囊下混浊。V4b组和V4c组各有2只眼（分别为10%和8.33%）发生旋转超过30度，需行再次旋转手术且手术成功。2只接受V4b ICL植入的眼（6.66%）术后眼压高（>35 mmHg），随后行Nd:YAG激光虹膜切开术，眼压得到成功控制。1年随访结束时，V4b组和V4c组的安全指数分别为1.12和1.15，有效指数分别为1.5和1.6。两组中最常见的视觉主诉分别为眩光和光晕，发生率分别为24%和27%。然而，它们并不足以令人烦恼到导致视力残疾。
V4b和V4c Visian ICL植入在矫正高度近视的视力结果和安全性方面具有可比性。然而，V4c ICL具有这些优势且无需额外的PI。
