State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, Guangdong, China.
Albany Medical College, Albany, New York, USA.
BMJ Open. 2023 Jun 27;13(6):e072542. doi: 10.1136/bmjopen-2023-072542.
Congenital ectopia lentis (CEL) is a rare ocular disease characterised by the dislocation or displacement of the lens. Patients with mild lens dislocations can be treated with conservative methods (eg, corrective eyeglasses or contact lenses). In contrast, patients with severe CEL usually require surgical management. However, few studies have focused on the visual prognosis and complications in conservative and surgical management of patients. This study aims to investigate the prognosis and complications in patients with CEL with conservative and surgical management, which is vital for CEL management, especially the choice of surgical timing and surgical method.
A cohort study will be conducted at Zhongshan Ophthalmic Center. We plan to recruit 604 participants diagnosed with CEL and aged ≥3 years old. Patients with mild lens subluxation and stable visual conditions will be included in the non-surgical group and follow-up at 1, 2 and 3 years after enrolment. Patients with severe lens subluxation who accept CEL surgery will be included in the surgical group. Different surgical techniques, including phacoemulsification, in-the-bag intraocular lens implantation (with or without capsular tension ring) and trans-scleral fixation, will be used depending on the severity of dislocation. Patients will be followed up at 3 months, and 1, 2 and 3 years postoperatively. Over a 5-year follow-up period, patients will receive a detailed ocular examination, including optometry, biological measurement, specular microscopy, ultrasound biomicroscopy, anterior segment and posterior segment optical coherence tomography (OCT), OCT angiography, echocardiography and questionnaires on vision-related quality of life. The primary outcome is the change of best-corrected visual acuity and the incidence of complications in both groups.
Ethics approval was obtained from the ethics committee of the Zhongshan Ophthalmic Center (number: 2022KYPJ207). Study findings will be published in a peer-reviewed journal.
NCT05654025.
先天性晶状体异位（CEL）是一种罕见的眼部疾病，其特征为晶状体脱位或移位。对于轻度晶状体脱位的患者，可以采用保守治疗方法（例如，矫正眼镜或隐形眼镜）。相比之下，对于严重 CEL 的患者，通常需要手术治疗。然而，很少有研究关注保守治疗和手术治疗患者的预后和并发症。本研究旨在探讨保守治疗和手术治疗 CEL 患者的预后和并发症，这对于 CEL 的治疗至关重要，特别是手术时机和手术方法的选择。
本研究将在中山大学中山眼科中心进行一项队列研究。我们计划招募 604 名年龄≥3 岁且被诊断为 CEL 的患者。将纳入晶状体轻度半脱位且视力稳定的患者进入非手术组，并在入组后 1、2 和 3 年进行随访。接受 CEL 手术的晶状体严重半脱位患者将纳入手术组。根据脱位的严重程度，采用不同的手术技术，包括超声乳化白内障吸除术、囊袋内人工晶状体植入术（带或不带囊袋张力环）和经巩膜固定术。患者将在术后 3 个月以及 1、2 和 3 年进行随访。在 5 年的随访期间，患者将接受详细的眼部检查，包括验光、生物测量、共焦激光角膜显微镜检查、超声生物显微镜检查、眼前段和后段光学相干断层扫描（OCT）、OCT 血管造影、超声心动图和与视力相关的生活质量问卷。主要结局是两组患者最佳矫正视力的变化和并发症的发生率。
本研究已获得中山大学中山眼科中心伦理委员会的批准（编号：2022KYPJ207）。研究结果将发表在同行评议的期刊上。
NCT05654025。
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