Governatori Lorenzo, Oliverio Leandro, Mermoud André, Scampoli Alessandra, Sarati Federica, Carradori Andrea, Catalani Roberta, Monaco Carlo, Caporossi Tomaso, Rizzo Stanislao
Vitreoretinal Surgery Unit, Isola Tiberina - Gemelli Isola Hospital, 00186, Rome, Italy.
Medical and Surgical Glaucoma Unit, Swiss Visio Montchoisi Clinic, 1006, Lausanne, Switzerland.
Graefes Arch Clin Exp Ophthalmol. 2025 Apr;263(4):885-899. doi: 10.1007/s00417-024-06649-w. Epub 2024 Oct 12.
This meta-analysis compares PreserFlo (PF) and trabeculectomy (TB) in moderate-to-advanced glaucoma (defined by visual fields with a mean deviation (MD) worse than -6 dB). Key outcomes include success rates (qualified success is defined as a target IOP of less than 21 mm Hg or a 20% reduction from baseline at the endpoint, with or without medications. Complete success is achieving these targets without any medications), intraocular pressure (IOP), complications, reinterventions, needling, glaucoma medication reduction, retinal nerve fibre layer (RNFL), and visual field progression.
We searched PubMed, Scopus, and Cochrane Central up to 13/01/24, including randomized and non-randomized studies with at least 2 months follow-up. Bias risk was assessed using ROB-2 for RCTs and ROBIN-I for non-RCTs. Publication bias was evaluated via funnel plots and Egger's regression.
Ten studies (n = 1833 eyes; 57.4% PF) were analyzed. Preoperative IOP was 22.1 mmHg; 56.1% had moderate-to-severe glaucoma. No significant differences were found in qualified (QSR) and complete success rates (CSR) between PF and TB. Trabeculectomy achieved better IOP outcomes (mean difference, MD 1.59 mmHg; p = 0.0004) and greater IOP reduction (MD -2.52 mmHg; p = 0.0003), but PF showed less visual field progression (MD -1.21; p = 0.03) and lower hypotony maculopathy risk (OR 0.30; p = 0.03). PF had a higher reintervention rate, particularly in patients without prior glaucoma surgery (OR 1.74; p = 0.02) or with primary open-angle glaucoma (OR 1.84; p = 0.04).
Trabeculectomy is more effective for uncontrolled glaucoma up to 2 years, while PF presents a lower risk of hypotony-related events and may benefit patients sensitive to visual field progression. Study strengths include detailed subgroup analyses and mid-term follow-up, with limitations noted in the number of RCTs.
What is known PreserFlo MicroShunt has been shown to provide an efficient surgical solution for intraocular pressure (IOP) control with a favourable safety profile. Compared to trabeculectomy thereis still contentious regarding the best surgical approach. What is new Trabeculectomy is more effective in uncontrolled glaucoma patients up to 2 years, particularly if lower target IOPs are considered. PreserFlo had lower hypotony-related events risk and may be preferred for patients sensitive to visual field loss. PreserFlo showed a higher risk of reintervention, especially without prior glaucoma surgery or primary open-angle glaucoma diagnosis.
本荟萃分析比较了PreserFlo（PF）和小梁切除术（TB）治疗中重度青光眼（定义为平均偏差（MD）低于-6 dB的视野）的效果。主要结局包括成功率（合格成功定义为眼压目标值低于21 mmHg或在终点时较基线降低20%，无论是否使用药物。完全成功是指无需任何药物即可达到这些目标）、眼压（IOP）、并发症、再次干预、针刺、青光眼药物减少、视网膜神经纤维层（RNFL）和视野进展。
我们检索了截至2024年1月13日的PubMed、Scopus和Cochrane Central，纳入至少随访2个月的随机和非随机研究。使用ROB-2评估随机对照试验（RCT）的偏倚风险，使用ROBIN-I评估非RCT的偏倚风险。通过漏斗图和Egger回归评估发表偏倚。
分析了10项研究（n = 1833只眼；57.4%为PF组）。术前眼压为22.1 mmHg；56.1%患有中重度青光眼。PF组和TB组在合格成功率（QSR）和完全成功率（CSR）方面无显著差异。小梁切除术在眼压控制方面取得了更好的效果（平均差值，MD 1.59 mmHg；p = 0.0004）和更大的眼压降低幅度（MD -2.52 mmHg；p = 0.0003），但PF组的视野进展较少（MD -1.21；p = 0.03）且低眼压性黄斑病变风险较低（OR 0.30；p = 0.03）。PF组的再次干预率较高，尤其是在未接受过青光眼手术的患者（OR 1.74；p = 0.02）或原发性开角型青光眼患者中（OR 1.84；p = 0.04）。
小梁切除术在2年内治疗未控制的青光眼更有效，而PF组与低眼压相关事件的风险较低，可能对视野进展敏感的患者有益。研究优势包括详细的亚组分析和中期随访，但RCT数量有限。
已知信息PreserFlo微型分流器已被证明是一种有效的眼压控制手术解决方案，具有良好的安全性。与小梁切除术相比，最佳手术方法仍存在争议。新发现小梁切除术在2年内对未控制的青光眼患者更有效，特别是如果考虑较低的眼压目标值。PreserFlo与低眼压相关事件的风险较低，可能是视野丧失敏感患者的首选。PreserFlo显示出较高的再次干预风险，尤其是在未接受过青光眼手术或未诊断为原发性开角型青光眼的情况下。
