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临床试验/NCT07129798
NCT07129798进行中(未招募)不适用

Efficacy and Safety of Myopic Macular Hole Closure Surgery Without Endotamponade Agent

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年1月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
20
试验地点
1
主要终点
Macular hole closure rate

研究概览

简要总结

Macular hole (MH) is a common condition that affects approximately 1.6/1000 elderly Chinese population. The prevalence is expected to be even higher in individuals with high myopia (HM), an established risk factor for MH. Without prompt surgical intervention, it can lead to irreversible vision loss and retinal detachment. Standard MH surgery involves pars plana vitrectomy (PPV) with internal limiting membrane (ILM peeling), followed by endotamponade agents to appose the MH edge.

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Common endotamponade agents include intraocular long-acting gas and silicone oil. The use of endotamponade has its limitations, for example, impairing vision, the need for strict posturing and avoid air travel in the early postoperative period. Ocular complications, such as uveitis, cataract and glaucoma may arise.

To overcome these shortcomings, a novel technique to close MH without endotamponade agents was proposed by a group from Poland. Using viscoelastics to stabilize ILM flap over the MH, negating the need and limitations of endotamponade agents. However, this case series is limited by its small sample size (12 eyes) and lack of patients with pathological myopia (PH).

PH is prevalent in the Asian population and myopic MH tend to have lower surgical success rate due to antero-posterior traction from posterior staphyloma and long axial length associated with PH. There is currently a gap in evidence whether this novel surgical technique could benefit eyes with myopic MH. The investigators plan to conduct a prospective interventional case series to establish the efficacy and safety of myopic MH closure using this novel surgical technique.

详细描述

Macular hole (MH) is a common condition that affects approximately 1.6/1000 elderly Chinese population. The prevalence is expected to be even higher in individuals with high myopia (HM), an established risk factor for MH. Without prompt surgical intervention, it can lead to irreversible vision loss and retinal detachment. Standard MH surgery involves pars plana vitrectomy (PPV) with internal limiting membrane (ILM peeling), followed by endotamponade agents to appose the MH edge.

Common endotamponade agents include intraocular long-acting gas and silicone oil. The use of endotamponade has its limitations, for example, impairing vision, the need for strict posturing and avoid air travel in the early postoperative period. Ocular complications, such as uveitis, cataract and glaucoma may arise.

To overcome these shortcomings, a novel technique to close MH without endotamponade agents was proposed by a group from Poland. Using viscoelastics to stabilize ILM flap over the MH, negating the need and limitations of endotamponade agents. However, this case series is limited by its small sample size (12 eyes) and lack of patients with pathological myopia (PH).

PH is prevalent in the Asian population and myopic MH tend to have lower surgical success rate due to antero-posterior traction from posterior staphyloma and long axial length associated with PH. There is currently a gap in evidence whether this novel surgical technique could benefit eyes with myopic MH. The investigators plan to conduct a prospective interventional case series to establish the efficacy and safety of myopic MH closure using this novel surgical technique.

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

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Aged 18 years or above
  • •Patients with full thickness macular hole, defined as full thickness foveal defect on OCT
  • •Patients with pathological myopia, defined as refractive error of </= -6.0D or axial length >/= 26.0mm with signs of posterior staphyloma, lacquer cracks or chorizo-retinal atrophy

排除标准

  • •Patients with concomitant retinal detachment
  • •Prior MH surgery
  • •Macular conditions other than MH, such as myopic choroidal neovascularization, age related macular degeneration and Diabetic Macular Edema
  • •Patients who cannot be cooperative with ophthalmic examination or give informed consent to undergo surgery
  • •Fellow eye already recruited in the study

研究组 & 干预措施

ILM flap with no endotamponade technique

Experimental

Patients with myopic macular hole (MH) will undergo pars plana vitrectomy (PPV) and the internal limiting membrane (ILM) flap with no gas tamponade technique to repair the MH.

干预措施: ILM flap with no endotamponade technique (Procedure)

结局指标

主要结局

Macular hole closure rate

时间窗: 3 months

Defined as closure of MH on optical coherence tomography (OCT)

次要结局

  • Post-operative best-corrected visual acuity(12 months)
  • MH closure pattern(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Simon KH Szeto

Assistant Professor

Chinese University of Hong Kong

研究点 (1)

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