Niu Lingling, Miao Huamao, Han Tian, Ding Lan, Wang Xiaoying, Zhou Xingtao
Department of Ophthalmology and Optometry, Eye and ENT Hospital, Fudan University, 83 Fen Yang Road, Shanghai, 200031, China.
Key NHC Key Laboratory of Myopia (Fudan University), 83 Fen Yang Road, Shanghai, 200031, China.
BMC Ophthalmol. 2019 May 29;19(1):121. doi: 10.1186/s12886-019-1132-z.
High myopia with shallow anterior chamber depth (ACD less than 2.8 mm) is not rare. This observational study aims to evaluate visual outcomes after implantation of the Visian Implantable Collamer Lens with a central hole (ICL V4c) in these patients.
A prospective cohort of consecutive 51 eyes of 31 patients (20 to 42 years old) was followed for at least 12 months (average 15.35 ± 4.90 months, rangers from 12 to 25 months). The preoperative ACD was 2.74 ± 0.04 mm (2.65 to 2.79 mm). Uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), intraocular pressure (IOP), manifest refraction, vault, and endothelial cell density (ECD) were measured during the follow-ups after surgery.
All surgeries were performed safely and no complication was observed during the follow-ups. At the last follow-up, the safety index (postoperative CDVA / preoperative CDVA) was 1.33 ± 0.60 and the efficacy index (postoperative UDVA / preoperative CDVA) was 1.14 ± 0.54. After the surgery, no eye had decreased CDVA and 59% (30 eyes) of the eyes gained at least one line. Forty-seven eyes (92%) were within ±1.0 D and 35 eyes (69%) were within ±0.5 D of the attempted refraction. The mean postoperative vault was 380.00 ± 152.84 μm (90 to 700 μm). The ECD was reduced by 8.38 ± 0.06% as compared to the preoperative value (p < 0.001). No significant change was observed in IOP (p = 0.061) at the last follow-up. Ultrasound Biomicroscopy (UBM) showed none of the eyes had trabecular-iris angle closed.
In this prospective observational study, ICL V4c implantation in patients with high myopia and shallow ACD achieved satisfying and stable visual outcomes. Its long-term safety and stability require further investigation.
This trial was retrospectively registered on 05/08/2018 under the number ( ChiCTR1800017594 ).
高度近视且前房深度浅(前房深度小于2.8毫米)并不罕见。本观察性研究旨在评估在这些患者中植入带中央孔的Visian可植入胶原晶状体(ICL V4c)后的视觉效果。
对31例患者(20至42岁)的连续51只眼进行前瞻性队列研究,随访至少12个月(平均15.35±4.90个月,范围为12至25个月)。术前前房深度为2.74±0.04毫米(2.65至2.79毫米)。在术后随访期间测量未矫正远视力(UDVA)、矫正远视力(CDVA)、眼压(IOP)、显验光、拱高和内皮细胞密度(ECD)。
所有手术均安全进行,随访期间未观察到并发症。在最后一次随访时,安全指数(术后CDVA/术前CDVA)为1.33±0.60,有效指数(术后UDVA/术前CDVA)为1.14±0.54。术后,没有眼睛的CDVA下降,59%(30只眼)的眼睛至少提高了一行视力。47只眼(92%)的屈光度在预期屈光度±1.0 D以内,35只眼(69%)在预期屈光度±0.5 D以内。术后平均拱高为380.00±152.84微米(90至700微米)。与术前值相比,ECD降低了8.38±0.06%(p<0.001)。在最后一次随访时,眼压无显著变化(p=0.061)。超声生物显微镜检查(UBM)显示没有眼睛的小梁-虹膜角关闭。
在这项前瞻性观察性研究中,在高度近视且前房深度浅的患者中植入ICL V4c可获得令人满意且稳定的视觉效果。其长期安全性和稳定性需要进一步研究。
本试验于2018年8月5日进行回顾性注册,注册号为(ChiCTR1800017594)。