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临床试验/NCT06798285
NCT06798285已完成不适用

Comparision of Retinal Function and Macular Structure After 27G Pars Plana Vitrectomy With Minimal Heads-up Versus Standard Illuminiation in Patients With Idiopthic Epiretinal Membranes

Pomeranian Medical University Szczecin2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年2月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Bioelectrical Retinal function

研究概览

简要总结

Purpose: To analyze the clinical benefits of using the NGENUITY 3D Visualization System in vitreoretinal surgery with low levels of endo-illumination, focusing on functional and structural retinal protection in patients with idiopathic epiretinal membranes (ERM).

Design: Prospective, randomized, comparative study. Methods: Forty pseudophakic patients (29♀, 11♂; age 60-80 years) with ERM underwent 27G pars plana vitrectomy (PPV) and were randomly divided into two groups: Group I (20 eyes, stand-ard microscope [Hi-R 900], endo-illumination 3.2 Lm) and Group II (20 eyes, 3D heads-up NGE-NUITY system, endo-illumination 0.5 Lm). Preoperative and 6-month postoperative evaluations included slit-lamp examination, intraocular pressure (IOP, Pascal tonometer), Distance Best Correct-ed Visual Acuity (DBCVA, logMAR), Central Subfield Thickness (CST), Retinal Nerve Fiber Layer Thickness (RNFL, OCT), Pattern ERG (PERG), multifocal ERG (mfERG), flash ERG (ERG, IS-CEV standards), and retinal sensitivity (HFA macula test). Surgery time, xenon light exposure, ERM/ILM peeling time, fundus autofluorescence (FAF), metamorphopsia incidence, and intra-/postoperative adverse events were analyzed. Results were statistically evaluated (p < 0.05).

研究设计

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

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • DBCVA > 0.1 (Snellen charts)
  • Pseudophakia
  • ERM without other abnormalities
  • Patient's consent to participate in the project with a 6-month follow-up after surgery.

排除标准

  • Systemic diseases known to influence retinal function (e.g., diabetes)
  • Psychiatric disorders
  • Advanced stages of cardiovascular diseases
  • Previous PPV
  • High myopia.

结局指标

主要结局

Bioelectrical Retinal function

时间窗: 6 months

The low intensity of endoillumination (0.5 Lm) utilized in PPV with the NGENUITY 3D system may reduce retinal phototoxicity compared to the higher intensity of light (3.2 Lm)

次要结局

  • Structural Macula Changes(6 months)
  • Changes DBCVA (Distance Best Corrected vision)(6 months)

研究者

发起方
Pomeranian Medical University Szczecin
申办方类型
Other
责任方
Sponsor

研究点 (2)

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