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临床试验/NCT07736690
NCT07736690已完成4 期

Perioperative Topical Nepafenac Enhances Early Anatomical and Functional Recovery After Epiretinal Membrane Surgery: A Prospective Comparative Study

Ankara Yildirim Beyazıt University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Change in Best-Corrected Visual Acuity (BCVA)

研究概览

简要总结

This prospective comparative study evaluates whether perioperative topical nepafenac improves early anatomical and functional recovery after pars plana vitrectomy with epiretinal membrane and internal limiting membrane peeling. The study compares postoperative visual acuity, central macular thickness, and other clinical outcomes between patients treated with perioperative nepafenac and those receiving standard postoperative care.

详细描述

Epiretinal membrane (ERM) surgery generally results in favorable anatomical outcomes; however, postoperative retinal inflammation may delay visual and structural recovery. Nepafenac is a topical nonsteroidal anti-inflammatory drug with excellent intraocular penetration and may reduce postoperative inflammation.

This prospective comparative study investigates the effect of perioperative topical nepafenac on early postoperative recovery following pars plana vitrectomy with epiretinal membrane and internal limiting membrane peeling.

Participants were assigned to receive either perioperative topical nepafenac or standard postoperative treatment. The primary objective is to compare anatomical recovery, measured by optical coherence tomography, and functional recovery, assessed by best-corrected visual acuity. Secondary outcomes include changes in central macular thickness and postoperative complications.

The findings may help determine whether perioperative topical nepafenac provides additional benefit in improving early postoperative outcomes after epiretinal membrane surgery.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 years or older.
  • Diagnosis of idiopathic epiretinal membrane requiring pars plana vitrectomy.
  • Best-corrected visual acuity impairment and/or metamorphopsia attributed to epiretinal membrane.
  • Ability to provide written informed consent.
  • Willingness to complete the scheduled follow-up examinations for 6 months.

排除标准

  • - Previous vitreoretinal surgery in the study eye.
  • Other retinal diseases that could affect visual or anatomical outcomes (e.g., diabetic retinopathy, retinal vein occlusion, age-related macular degeneration).
  • Significant ocular trauma.
  • Active ocular inflammation or infection.
  • Advanced glaucoma or optic neuropathy affecting visual function.
  • Media opacity preventing adequate retinal imaging.

结局指标

主要结局

Change in Best-Corrected Visual Acuity (BCVA)

时间窗: 6 months after surgery

To compare the change in best-corrected visual acuity (logMAR) between the perioperative nepafenac group and the control group following epiretinal membrane surgery.

次要结局

  • Change in Central Macular Thickness (CMT)(6 months after surgery)
  • Integrity of the Ellipsoid Zone(6 months after surgery)
  • Postoperative Complications(6 months after surgery)

研究者

发起方
Ankara Yildirim Beyazıt University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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