Vastardis Iraklis, Fili Sofia, Perdikakis Georgios, Kontopoulou Kalliopi, Balidis Miltos, Gatzioufas Zisis, Kohlhaas Markus
Department of Ophthalmology, St. Johannes Academic Hospital Dortmund, Dortmund, Germany.
Ophthalmica Eye Institute, Thessaloniki, Greece.
Eye Vis (Lond). 2021 Sep 3;8(1):33. doi: 10.1186/s40662-021-00253-3.
To report preliminary 6-month results on the use of the Preserflo Microshunt implant with and without Ologen in 50 pseudophakic eyes with moderate to advanced primary open-angle glaucoma (POAG).
Fifty pseudophakic eyes underwent ab externo Preserflo Microshunt implantation. Data was gathered retrospectively and two groups were then created, group A with application of MMC 0.2 mg/ml and group B with MMC 0.2 mg/ml and Ologen collagen matrix (OCM) implantation. Absolute success was regarded as the percentage of eyes achieving: a) 5 ≤ intraocular pressure (IOP) ≤ 13 mmHg, b) 5 ≤ IOP ≤ 16 mmHg, and c) 5 ≤ IOP ≤ 21 mmHg without additional medication or surgery and qualified success was regarded as the percentage of eyes achieving a) IOP ≤ 13 mmHg, b) IOP ≤ 16 mmHg, and c) IOP ≤ 21 mmHg with or without medication. Evaluation was performed using a log-rank Kaplan-Meier test. A scatterplot analysis presented the treatment effect data of all eyes with a minimum of 20% IOP reduction per case. Failure was defined as requiring additional surgery, IOP greater than 21 mmHg with or without medication and failure to reach 20% IOP reduction.
Mean postoperative IOP was significantly lower in both groups. IOP decreased by 49.06% in group A and by 53.01% in group B at 6 months (P < 0.88), respectively. Medication use was lower in both groups (Wilcoxon test, P < 0.001). The absolute and qualified success rates were not statistically significant between the groups (all P > 0.05). Cumulative IOP results per case were not statistically different in group A compared with group B. One revision surgery in group A (4% failure rate) and three in group B (12% failure rate) were performed.
Both groups showed equal results in terms of cumulative and mean IOP reduction, medication reduction as well as in absolute and qualified success rates. No significant difference was found in any parameters tested between Preserflo Microshunt with MMC 0.2 mg/ml and with or without OCM implantation at 6 months. Long-term follow-up is required to further evaluate this data.
报告在50只患有中度至重度原发性开角型青光眼（POAG）的人工晶状体眼内使用Preserflo微型分流器植入物（伴或不伴Ologen）6个月的初步结果。
50只人工晶状体眼接受了外路Preserflo微型分流器植入术。回顾性收集数据，然后分为两组，A组应用0.2mg/ml丝裂霉素C（MMC），B组应用0.2mg/ml MMC并植入Ologen胶原基质（OCM）。绝对成功定义为达到以下标准的眼的百分比：a）5≤眼压（IOP）≤13mmHg，b）5≤IOP≤16mmHg，c）5≤IOP≤21mmHg，且无需额外药物或手术；合格成功定义为达到以下标准的眼的百分比：a）IOP≤13mmHg，b）IOP≤16mmHg，c）IOP≤21mmHg，无论是否使用药物。使用对数秩Kaplan-Meier检验进行评估。散点图分析展示了所有眼压每例至少降低20%的眼的治疗效果数据。失败定义为需要额外手术、无论是否使用药物眼压大于21mmHg以及眼压降低未达到20%。
两组术后平均眼压均显著降低。6个月时，A组眼压降低49.06%，B组降低53.01%（P<0.88）。两组药物使用量均减少（Wilcoxon检验，P<0.001）。两组间绝对成功率和合格成功率无统计学差异（所有P>0.05）。A组与B组相比，每例累积眼压结果无统计学差异。A组进行了1次翻修手术（失败率4%），B组进行了3次（失败率12%）。
两组在累积和平均眼压降低率、药物减少量以及绝对成功率和合格成功率方面结果相当。在6个月时，应用0.2mg/ml MMC的Preserflo微型分流器伴或不伴OCM植入，在所测试的任何参数上均未发现显著差异。需要长期随访以进一步评估该数据。
