Verma-Fuehring Raoul, Matlach Juliane, Klink Thomas, Hillenkamp Jost, Grehn Franz
Department of Ophthalmology, University Hospital Würzburg, Würzburg, Germany.
Department of Ophthalmology, University Hospital Leipzig, Leipzig, Germany.
BMC Ophthalmol. 2025 Jun 16;25(1):340. doi: 10.1186/s12886-025-04183-9.
To assess the long-term outcomes of the Trabeculectomy versus Canaloplasty (TVC) study cohort after 11 years. The TVC study was a prospective, single-center, randomized clinical trial comparing the 24-month surgical outcomes of trabeculectomy and canaloplasty in patients with open-angle glaucoma.
This prospective follow-up study included only patients from the original 2015 TVC cohort. Primary endpoints were complete (without glaucoma medication) and qualified success (with or without glaucoma medication), defined as intraocular pressure (IOP) ≤ 18 mmHg (Definition 1) or IOP ≤ 21 mmHg with ≥ 20% reduction from baseline (Definition 2). Secondary endpoints included changes in IOP, medication use, complications, and revision surgeries.
Mean follow-up was 11.9 ± 1.1 years for trabeculectomy (TE) and 11.0 ± 2.0 years for canaloplasty (CP) (15 TE and 13 CP patients). Complete success rates for TE vs. CP were 53.3% vs. 15.4% (Definition 1, p = 0.06) and 46.7% vs. 15.4% (Definition 2, p = 0.22). Qualified success was achieved by 73.3% vs. 69.2% (Definition 1, p = 1.0) and 66.7% vs. 76.9% (Definition 2, p = 0.69). Median IOP was 10.0 (6.0-12.0) mmHg for TE and 14.0 (11.5-17.75) mmHg for CP (p < 0.01). Mean number of compounds was 1.0 ± 1.4 in TE and 1.9 ± 1.5 in CP (p = 0.17). Revision surgeries were needed in 26.7% (TE) vs. 23.1% (CP). The only long-term complication, hypotony maculopathy, occurred in two TE patients (15.4%).
After 11 years, trabeculectomy still demonstrated greater IOP reduction and higher complete success rates but was associated with a higher complication rate. In contrast, canaloplasty offers a safe alternative when slightly higher IOPs and moderate medication use are acceptable.
评估小梁切除术与睫状体光凝术（TVC）研究队列11年后的长期疗效。TVC研究是一项前瞻性、单中心、随机临床试验，比较了开角型青光眼患者小梁切除术和睫状体光凝术的24个月手术疗效。
这项前瞻性随访研究仅纳入了2015年TVC原始队列中的患者。主要终点为完全成功（无需使用青光眼药物）和合格成功（无论是否使用青光眼药物），定义为眼压（IOP）≤18 mmHg（定义1）或眼压≤21 mmHg且较基线降低≥20%（定义2）。次要终点包括眼压变化、药物使用、并发症和翻修手术。
小梁切除术（TE）的平均随访时间为11.9±1.1年，睫状体光凝术（CP）为11.0±2.0年（15例TE患者和13例CP患者）。TE与CP的完全成功率分别为53.3%和15.4%（定义1，p = 0.06）以及46.7%和15.4%（定义2，p = 0.22）。合格成功率分别为73.3%和69.2%（定义1，p = 1.0）以及66.7%和76.9%（定义2，p = 0.69）。TE的眼压中位数为10.0（6.0 - 12.0）mmHg，CP为14.0（11.5 - 17.75）mmHg（p < 0.01）。TE的平均用药种类数为1.0±1.4种，CP为1.9±1.5种（p = 0.17）。TE组和CP组分别有26.7%和23.1%的患者需要进行翻修手术。唯一的长期并发症——低眼压性黄斑病变，发生在2例TE患者中（15.4%）。
11年后，小梁切除术在降低眼压方面仍表现出更大的效果和更高的完全成功率，但并发症发生率较高。相比之下，当可接受稍高的眼压和适度使用药物时，睫状体光凝术是一种安全的替代方法。
