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临床试验/NCT04158791
NCT04158791已完成不适用

Surgery for Idiopathic Epimacular Membrane: Morpho-functional Outcomes Based on the Pre-operative Macular Integrity of Photoreceptoral Junction. A Prospective Pilot Study.

Fondazione IRCCS Policlinico San Matteo di Pavia1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2018年3月25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
18
试验地点
1
主要终点
Imortance of the pre-operative integrity or not of the inner segment (IS) and outer segment (OS) photoreceptoral junction in the change of the post-operative visual acuity after 1, 3 and 6 months of follow-up after surgical treatment for EMM

研究概览

简要总结

The aim of this study is to evaluate whether the pre-operative integrity or not of the inner segment (IS) and outer segment (OS) photoreceptoral junction may influence the post-operative visual acuity, the macular morphology (assessed by Spectral Domain-Optical Coherence Tomography (SD-OCT)) and function (evaluated by Multifocal Electroretinogram -mfERG) in patients with idiopathic epimacular membrane (EMM) followed-up for 6-month.

In this observational prospective study, EMM patients are enrolled. They are divided into 2 groups in relationship to the pre-operative integrity of the SD-OCT IS/OS junction: the group with an intact IS/OS junction (EMM-I Group) and the group with a disrupted IS/OS junction (EMM-D Group). For each enrolled patient, visual acuity (VA), mfERG and SD-OCT were assessed at baseline (pre-operative) and after 1, 3 and 6 months of follow-up after surgical treatment for EMM (pars plana vitrectomy with EMM removal and internal limiting membrane peeling).

详细描述

In this observational study, patients with idiopathic EMM, undergoing pars plana vitrectomy with Inner Limiting Membrane (ILM) peeling, at the Ophtalmology Clinic of IRCCS Policlinico San Matteo, are enrolled.

The clinical diagnosis of EMM is based on indirect binocular ophthalmoscopy with a + 90 D no-contact lens (Volk Optical Inc., Ohio, USA) and on the SD-OCT examination (see below) which revealed an increase in macular volume associated with optically hyperreflective epiretinal echoes due to the presence of a membrane.

Since several pathologies may induce changes of the macula bioelectrical responses, and their presence may represent potential confounding factors, patients enrolled in the present study were selected from a large EMM cohort of patients after exclusion of presence of dense lens opacities, ocular hypertension or glaucoma, diabetic retinopathy, drusen and age-related macular disease, other general diseases such as systemic hypertension, diabetes, connective tissue or neurological diseases.

Based on that reported by Falkner-Radler et al. , our patient are divided into 2 groups in relationship to the integrity of IS/OS junction: a group in which an intact IS/OS junction was identified by SD-OCT examination (EMM-I Group) and a group in which a disrupted IS/OS junction was observed by SD-OCT examination, EMM-D Group.

Evaluation of photoreceptor status is performed on the central part of the 1.5 mm of two perpendicular scans centered on the fovea. The intact IS/OS junction is identified as a continuous hyperreflective line ; the disrupted IS/OS junction is identified as interruptions of the normal hyperreflective line. Classification was assessed by the agreement of two different grader. In case of disagreement a third assessment was obtained by another expert grader.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • patients with idiopathic epimacular membrane

排除标准

  • presence of dense lens opacities, ocular hypertension or glaucoma, diabetic retinopathy, drusen and age-related macular disease, other general diseases such as systemic hypertension, diabetes, connective tissue or neurological diseases.

结局指标

主要结局

Imortance of the pre-operative integrity or not of the inner segment (IS) and outer segment (OS) photoreceptoral junction in the change of the post-operative visual acuity after 1, 3 and 6 months of follow-up after surgical treatment for EMM

时间窗: 6 months

Visual acuity (VA)was assessed at baseline (pre-operative) and after 1, 3 and 6 months of follow-up after surgical treatment for EMM (pars plana vitrectomy with EMM removal and internal limiting membrane peeling

Importance of the pre-operative integrity or not of the inner segment (IS) and outer segment (OS) photoreceptoral junction in the change of the post-operative macular morphology after 1, 3 and 6 months of follow-up after surgical treatment for EMM

时间窗: 6 months

SD-OCT (assessing macular morphology) was assessed at baseline (pre-operative) and after 1, 3 and 6 months of follow-up after surgical treatment for EMM (pars plana vitrectomy with EMM removal and internal limiting membrane peeling

Importance of the pre-operative integrity or not of the inner segment (IS) and outer segment (OS) photoreceptoral junction in the change of the post-operative macular function after 1, 3 and 6 months of follow-up after surgical treatment for EMM

时间窗: 6 months

mfERG (assessing macular function) was assessed at baseline (pre-operative) and after 1, 3 and 6 months of follow-up after surgical treatment for EMM (pars plana vitrectomy with EMM removal and internal limiting membrane peeling

次要结局

未报告次要终点

研究者

发起方
Fondazione IRCCS Policlinico San Matteo di Pavia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlo Bruttini

Principal Investigator

Fondazione IRCCS Policlinico San Matteo di Pavia

研究点 (1)

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