Efficacy and Safety of Myopic Macular Hole Closure Surgery Without Endotamponade Agent
- Conditions
- Macular HoleMyopia
- Registration Number
- NCT07129798
- Lead Sponsor
- Chinese University of Hong Kong
- Brief Summary
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.
Office of Research and Knowledge Transfer Services
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. We plan to conduct a prospective interventional case series to establish the efficacy and safety of myopic MH closure using this novel surgical technique.
- Detailed Description
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. We plan to conduct a prospective interventional case series to establish the efficacy and safety of myopic MH closure using this novel surgical technique.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Macular hole closure rate 3 months Defined as closure of MH on optical coherence tomography (OCT)
- Secondary Outcome Measures
Name Time Method Post-operative best-corrected visual acuity 12 months BCVA
MH closure pattern 12 months Grading of MH closure pattern based on OCT
Trial Locations
- Locations (1)
Hong Kong Eye Hospital
🇭🇰Kowloon, Hong Kong
Hong Kong Eye Hospital🇭🇰Kowloon, Hong Kong