Corneal Neurotization Via Sural Nerve Transfer or Cadaveric Nerve Graft for Neurotrophic Keratopathy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Corneal sensation
研究概览
简要总结
The purpose of this study is to assess the efficacy of sural nerve transfer and cadaveric nerve graft to re-establish corneal sensation in patients with neurotrophic keratopathy.
详细描述
Corneal anesthesia, which can lead to visually devastating outcomes from ulceration, perforation, and scarring, can be recalcitrant to both medical and surgical treatment[1-3]. Neurotization is a revolutionary technique reported to restore corneal sensation in neurotrophic keratopathy[4-6]. Prior techniques described include direct neurotization with contralateral supraorbital and supratrochlear nerves accessed via a bicoronal incision of the scalp over the forehead[5]; nerve grafting with contralateral supratrochlear nerves accessed via a medial upper eyelid incision[6]; and sural nerve grafting to contralateral supratrochlear nerves accessed via a transverse incision over the medial upper eyelid[4]. Despite the challenges associated with these techniques (needing to subcutaneously tunnel the nerve graft over the nasal bridge or requiring a large bicoronal incision), these techniques all demonstrated efficacy in direct neurotization to improve corneal sensation in these patients.
The investigators aim to assess the efficacy of this innovative surgical technique involving coaptation of the sural nerve or cadaveric nerve allograft to an intact sensory branch of the trigeminal nerve to restore corneal sensation. The investigators have previously described the anatomic feasibility of using the infraorbital nerve using a cadaveric model, of which the results were presented at the American Society of Ophthalmic Plastic and Reconstructive Society Fall meeting in 2017. Utilization of the infraorbital nerve provides advantages over existing techniques due to ease of access via a cosmetically favorable incision, large caliber with increased ability to create a perineural window, relatively short and direct tunnel with possibly more rapid neurotization, and absence of complex surrounding anatomical structures. Others have previously describe success using the contralateral and ipsilateral supraorbital nerve and supratrochlear nerve.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with neurotrophic cornea
排除标准
- •Patients with history of penetrating keratoplasty
结局指标
主要结局
Corneal sensation
时间窗: Baseline (pre-operative) to 12 months postoperatively
Corneal sensation will be measured via Cochet Bonnet esthesiometry
次要结局
- Corneal opacity(Baseline (pre-operative) to 12 months postoperatively)
- Visual acuity(Baseline (pre-operative) to 12 months postoperatively)
研究者
Andrea L Kossler
Director, Oculoplastic Surgery & Orbital Oncology Assistant Professor of Ophthalmology
Stanford University
