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临床试验/NCT06664515
NCT06664515已完成不适用

Changes in Macular Pigment Optical Density After Full-thickness Macular Hole Closure Using Inverted Flap Technique

Federico II University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年6月1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
15
试验地点
1
主要终点
MPOD After Full-thickness Macular Hole Closure (FTMH)

研究概览

简要总结

The notable increase in MPOD following successful surgery suggests its potential role as a valuable adjunctive biomarker associated with a good visual prognosis following this type of macular hole surgical interventions.

详细描述

Full-thickness macular hole (FTMH) is a debilitating retinal disorder, particularly in its advanced forms, necessitating surgical intervention for vision restoration. This study showes the successful closure of a large FTMH using the inverted flap technique, highlighting the essential role of multimodal imaging, and particularly of macular pigment optical density (MPOD) assessment, in preoperative and postoperative evaluation.

Surgery was performed by an expert vitreoretinal surgeon, resulting in significant postoperative improvements in visual acuity and retinal architecture. Multimodal imaging, including MPOD assessment, played a pivotal role in preoperative evaluation and postoperative monitoring.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • age older than 60 years
  • diagnosis of FTHM
  • absence of other ocular diseases, responsible for macular edema (retinal vein occlusion, diabetic retinopathy, age-related macular degeneration

排除标准

  • No diagnosis of pseudophakic cystoid macular oedema
  • previous treatment for pseudophakic cystoid macular oedema
  • presence of other ocular diseases, responsible for macular edema (retinal vein occlusion, diabetic retinopathy, age-related macular degeneration)

结局指标

主要结局

MPOD After Full-thickness Macular Hole Closure (FTMH)

时间窗: 6 months

The parameters analyzed by OCT and MPOD six months after surgery are: OCT MPOD visual acuity

MPOD and Macula hole: before and after surgery

时间窗: six months

The parameters analyzed six months after surgery are: MPOD Visual acuity OCT

次要结局

未报告次要终点

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ciro Costagliola

director

Federico II University

研究点 (1)

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