METHODS: This retrospective single-center study involved 180 eyes of 180 participants who underwent XEN45 Gel Stent implantation, of which 60 eyes received combined surgery with phacoemulsification (combined group). Standalone stent implantation was performed on 60 phakic (phakic group) and on 60 pseudophakic eyes (pseudophakic group). The groups were matched in a ratio of 1:1:1 based on multiple criteria. Successful surgery was defined by three scores: IOP at the longest follow-up of < 21 mmHg (Score A) or < 18 mmHg (Score B) and an IOP reduction > 20% or IOP ≤ 15 mmHg and an IOP reduction ≥ 40% (Score C). In all scores, one open conjunctival revision was allowed, and additional repeat surgery was considered a failure.
RESULTS: After an average follow-up time interval of 20.6 ± 12.6 months, there was a mean IOP-reduction by 37% among the entire cohort. Comparative analysis between the three groups did not show significant differences regarding postoperative IOP, postoperative medication score, side effects, revision rate, repeat surgery rate or success rate. A dysfunctional stent was detected in eight eyes (4%) during open conjunctival revision in 76 eyes.
CONCLUSIONS: The clinical endpoints investigated did not differ significantly among either phakic or pseudophakic patients who received standalone stent implantation and patients who underwent combined surgery. However mean latency between primary stent implantation and first revision surgery after combined surgery was markedly shorter.
方法:这项回顾性单中心研究涉及180名接受XEN45凝胶支架植入的参与者的180只眼,其中60只眼接受超声乳化联合手术(联合组)。在60只晶状体眼(晶状体组)和60只假晶状体眼(假晶状体组)上进行了独立支架植入。基于多个标准,这些组以1:1:1的比例进行匹配。手术成功的定义为三个评分:最长随访时IOP<21mmHg(评分A)或<18mmHg(评分B),IOP降低>20%或IOP≤15mmHg,IOP降低≥40%(评分C)。在所有分数中,允许一次开放性结膜翻修,额外的重复手术被认为是失败的.
结果:平均随访时间为20.6±12.6个月,在整个队列中,平均IOP降低了37%.三组之间的比较分析显示术后眼压没有显着差异。术后用药评分,副作用,修订率,重复手术率或成功率。在76只眼的开放性结膜翻修期间,在8只眼(4%)中检测到功能失调的支架。
结论:研究的临床终点在接受独立支架植入的有晶状体或假晶状体患者和接受联合手术的患者中没有显著差异。然而,联合手术后初次支架植入和首次翻修手术之间的平均潜伏期明显较短。