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Phacovitrectomy Versus Pars Plana Vitrectomy Alone for Post-Intravitreal Injection Endophthalmitis

2026年7月16日 更新者:Ehab Mohamed Elsayed Mohamed Saad、Benha University

Outcomes of Phacovitrectomy Versus Pars Plana Vitrectomy Alone in Patients With Post-Intravitreal Injection Endophthalmitis: A Retrospective Comparative Cohort Study

This prospective comparative interventional study evaluated the anatomical and visual outcomes of phacovitrectomy versus pars plana vitrectomy (PPV) alone in patients with post-intravitreal injection endophthalmitis. Eligible patients underwent either combined phacovitrectomy or PPV alone according to the study protocol. The primary outcome was the change in best-corrected visual acuity (BCVA) from baseline to 3 months after surgery. Secondary outcomes included postoperative complications, need for additional surgical intervention, resolution of intraocular inflammation, and restoration of media clarity.

研究概览

详细说明

Post-intravitreal injection endophthalmitis is a rare but vision-threatening complication that requires prompt surgical intervention to maximize visual recovery. Pars plana vitrectomy (PPV) is the standard surgical treatment for severe cases; however, whether combining cataract extraction with vitrectomy provides superior anatomical and functional outcomes remains uncertain.

This prospective comparative interventional study was conducted to compare phacovitrectomy with PPV alone in the management of post-intravitreal injection endophthalmitis. Consecutive eligible phakic patients presenting with post-intravitreal injection endophthalmitis were enrolled between 2024 and June 2026 and underwent one of the two surgical approaches according to the study protocol.

Baseline demographic and clinical data were collected, including age, sex, indication for the original intravitreal injection, presenting best-corrected visual acuity (BCVA), clinical findings, microbiological results, and the interval between symptom onset and surgery. Operative details and postoperative follow-up data were prospectively recorded.

The primary outcome measure was the change in BCVA (logMAR) from baseline to 3 months after surgery. Secondary outcome measures included postoperative complications (such as retinal detachment, hypotony, persistent corneal edema, and recurrent infection), the need for additional surgical interventions, resolution of intraocular inflammation, restoration of media clarity, and anatomical success.

Comparative analyses were performed between the two treatment groups using appropriate statistical methods. Multivariable analyses were used to adjust for potential confounding factors, including baseline visual acuity, microbiological culture results, and time from presentation to surgery. The study aimed to determine whether combined phacovitrectomy provides superior visual and anatomical outcomes compared with PPV alone in patients with post-intravitreal injection endophthalmitis.

研究类型

介入性

注册 (实际的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Benha
      • Banhā、Benha、埃及、13111
        • Benha University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Adults aged 18 years or older.
  • Clinical diagnosis of acute post-intravitreal injection infectious endophthalmitis.
  • History of intravitreal injection before the onset of endophthalmitis.
  • Phakic eye at the time of presentation.
  • Eyes with persistent or worsening clinical signs despite initial intravitreal antibiotic therapy (vancomycin and ceftazidime), requiring surgical intervention.
  • Underwent either combined phacovitrectomy or pars plana vitrectomy alone as the primary surgical treatment.
  • Ability to complete at least 3 months of postoperative follow-up.

Exclusion Criteria:

  • Endophthalmitis secondary to causes other than intravitreal injection (e.g., post-cataract surgery, glaucoma surgery, penetrating ocular trauma, or endogenous endophthalmitis).
  • Previous vitrectomy in the study eye.
  • Pre-existing ocular conditions likely to significantly affect visual outcomes, including retinal detachment, advanced optic neuropathy, advanced glaucoma, or dense corneal opacity.
  • Eyes with no visual potential before the onset of endophthalmitis.
  • Inability to complete the scheduled follow-up visits or missing primary outcome data.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Phacovitrectomy
Twenty participants with post-intravitreal injection endophthalmitis underwent combined phacoemulsification with intraocular lens implantation and pars plana vitrectomy as the primary surgical treatment. Standard intravitreal antibiotics were administered according to the study protocol when indicated.
Combined phacoemulsification with intraocular lens implantation and standard 23- or 25-gauge pars plana vitrectomy performed as the primary surgical treatment for post-intravitreal injection endophthalmitis. Vitrectomy included removal of vitreous opacities and inflammatory debris with intravitreal administration of antibiotics according to the study protocol.
其他名称:
  • Combined phacoemulsification and pars plana vitrectomy
有源比较器:Pars Plana Vitrectomy Alone
Twenty participants with post-intravitreal injection endophthalmitis underwent pars plana vitrectomy alone as the primary surgical treatment. Standard intravitreal antibiotics were administered according to the study protocol when indicated.
Standard 23- or 25-gauge pars plana vitrectomy performed as the primary surgical treatment for post-intravitreal injection endophthalmitis without simultaneous cataract extraction. Vitrectomy included removal of vitreous opacities and inflammatory debris with intravitreal administration of antibiotics according to the study protocol.
其他名称:
  • PPV

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Best-Corrected Visual Acuity (BCVA)
大体时间:Baseline and 3 months after surgery
Change in best-corrected visual acuity (BCVA) measured in logarithm of the minimum angle of resolution (logMAR) from baseline to 3 months after surgery. Outcomes will be compared between the phacovitrectomy and pars plana vitrectomy groups.
Baseline and 3 months after surgery

次要结果测量

结果测量
措施说明
大体时间
Need for Additional Surgical Intervention
大体时间:Up to 3 months after surgery
Number of participants requiring additional vitreoretinal surgery or other ocular surgical intervention following the initial procedure.
Up to 3 months after surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年1月15日

初级完成 (实际的)

2026年6月19日

研究完成 (实际的)

2026年6月20日

研究注册日期

首次提交

2026年7月16日

首先提交符合 QC 标准的

2026年7月16日

首次发布 (实际的)

2026年7月21日

研究记录更新

最后更新发布 (实际的)

2026年7月21日

上次提交的符合 QC 标准的更新

2026年7月16日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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