Macular Resurfacing Using Autologous ILM Patch Transposition for Idiopathic Epiretinal Membrane
Macular Resurfacing With Non-Inverted Autologous Internal Limiting Membrane Patch Transposition for Idiopathic Epiretinal Membrane: A Multidimensional Evaluation of Efficacy and Foveal Microstructural Remodeling
Idiopathic epiretinal membrane is a condition in which abnormal tissue grows on the surface of the retina and can cause blurred vision and distortion. The standard surgical treatment is removal of this membrane, but some patients may not achieve complete visual recovery because the normal structure of the central retina may not fully restore after surgery.
This study is a prospective randomized controlled trial designed to evaluate a new surgical technique called macular resurfacing using an autologous internal limiting membrane patch transposition. The technique uses a patient's own retinal tissue to cover the macular area after epiretinal membrane removal, with the aim of promoting more natural healing of the retinal surface.
Patients with idiopathic epiretinal membrane will be randomly assigned to receive either the new surgical technique or conventional epiretinal membrane peeling. Visual function and retinal structural changes will be evaluated using visual examinations and multimodal retinal imaging during follow-up. The study aims to determine whether this new technique can improve visual outcomes and promote better restoration of macular microstructure.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Diagnosis of epiretinal membrane confirmed by Spectral-domain Optical Coherence Tomography
- Best corrected visual acuity <= 0.8 (equivalent to 0.1 LogMAR)
- Presence of metamorphopsia confirmed by Amsler grid testing
- Ability to understand the study information and provide written informed consent voluntarily
Exclusion Criteria:
- History of intraocular surgery, with the exception of uncomplicated cataract surgery
- Presence of any of the following ocular diseases: retinal vascular diseases (including diabetic retinopathy, retinal hemangioma, retinal vascular occlusion, Coats' disease, etc.), uveitis, macular degeneration, macular hole, retinal detachment, retinoschisis, pathologic myopia, ocular trauma, intraocular tumor and neurofibromatosis.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Non-Inverted Autologous ILM Patch Transposition Group
|
After standard pars plana vitrectomy and epiretinal membrane removal, the internal limiting membrane (ILM) was peeled from the central fovea to the vascular arcades.
A piece of healthy ILM free of ERM from the paramacular region was prepared as a patch for subsequent coverage, while its pedicle remained anchored to the paramacular site.
A perfluorocarbon liquid bubble was injected into the vitreous cavity to flatten the ILM patch and facilitate manipulation.
The patch was then detached and carefully transposed to resurface the macular area.
|
|
アクティブコンパレータ：Conventional ERM/ILM Peeling Group
|
After standard pars plana vitrectomy and epiretinal membrane removal, the ILM was peeled from the central fovea to the vascular arcades, without additional ILM patch transplantation.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Best Corrected Visual Acuity
時間枠：From baseline to 12 months
|
From baseline to 12 months
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- XH-2026-042
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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