Li Daniel Q, Gauvin Mathieu, Rocha Guillermo, Trottier Pierre, Racine Louis, Wallerstein Avi
Department of Ophthalmology and Visual Sciences, McGill University, 5252 Maisonneuve Blvd W, 4th floor,, Montreal, Québec, H4A 3S5, Canada.
Vision Group Canada, Montreal, QC, Canada.
BMC Ophthalmol. 2025 Jan 24;25(1):44. doi: 10.1186/s12886-024-03828-5.
To assess refractive and visual outcomes of a spherical Implantable Collamer Lens (ICL) followed by planned postoperative adjunctive laser-assisted in situ keratomileusis (LASIK) in the treatment of high compound hyperopic astigmatism.
In this prospective, multi-center, multi-surgeon, single-arm trial, eyes with ≥ 3.50 D hyperopia and ≥ 2.00 D of astigmatism underwent surgery receiving a spherical Implantable Collamer Lens (ICL) followed by a planned adjunctive LASIK postoperatively. Outcomes measures included postoperative uncorrected (UDVA) and corrected distance visual acuity (CDVA), manifest refraction, spherical (SEQ) and defocus equivalent (DEQ), efficacy index, safety index, and astigmatism vector analyses.
48 eyes had a mean sphere of 6.18 ± 1.35 D and mean cylinder of 2.69 ± 0.89 D preoperatively. After ICL and LASIK, 94% of eyes achieved a UDVA within 1 line of preoperative CDVA. Efficacy and safety indices were 0.94 ± 0.13 and 1.00 ± 0.13, respectively. We obtained near-to-emmetropia SEQ postoperatively (mean - 0.03 ± 0.43D), and the scatterplot of attempted versus achieved refractive correction revealed a predictable procedure (R = 0.89). 93.8% and 100% of eyes achieved target SEQ within 0.75 and 1.00 D. 87.5% and 100% of eyes were within 0.50 and 0.75 D of intended plano cylinder.
Spherical ICL with postoperative adjunctive LASIK was safe with good early visual and refractive outcomes. The combined modality is a promising approach to treating high compound hyperopic astigmatism where toric hyperopic ICL is not available.
This trial was retrospectively registered on ClinicalTrials.gov with the trial registration number NCT06742541.
评估球形可植入角膜接触镜（ICL）联合计划中的术后辅助准分子原位角膜磨镶术（LASIK）治疗高度复合远视散光的屈光和视觉效果。
在这项前瞻性、多中心、多术者、单臂试验中，远视≥3.50 D且散光≥2.00 D的眼睛接受手术，植入球形可植入角膜接触镜（ICL），术后计划进行辅助性LASIK。结果指标包括术后裸眼远视力（UDVA）和矫正远视力（CDVA）、显验光、球镜度（SEQ）和离焦等效度（DEQ）、疗效指数、安全指数以及散光矢量分析。
48只眼术前平均球镜度为6.18±1.35 D，平均柱镜度为2.69±0.89 D。ICL和LASIK术后，94%的眼睛裸眼远视力达到术前矫正远视力的1行以内。疗效指数和安全指数分别为0.94±0.13和1.00±0.13。术后获得了接近正视的球镜度（平均-0.03±0.43D），尝试的屈光矫正与实际获得的屈光矫正散点图显示该手术具有可预测性（R = 0.89）。93.8%和100%的眼睛在0.75 D和1.00 D范围内达到目标球镜度。87.5%和100%的眼睛柱镜度在预期平光镜的0.50 D和0.75 D范围内。
球形ICL联合术后辅助性LASIK安全，早期视觉和屈光效果良好。在没有散光远视ICL的情况下，这种联合方式是治疗高度复合远视散光的一种有前景的方法。
本试验在ClinicalTrials.gov上进行了回顾性注册，试验注册号为NCT06742541。
