Macular Hole, Myopia
Conditions
Keywords
Macular hole, High Myopia, Vitrectomy, Internal limiting membrane flap, No endotamponade
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. 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.
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. 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.
Interventions
PROCEDUREILM flap with no endotamponade technique
Standard 3-port pars plana vitrectomy will be performed under either local anesthesia or general anesthesia. After core vitrectomy, posterior vitreous detachment induction will be done using vitrectomy cutter suction with the staining of intravitreal triamcinolone if necessary. This is followed by staining of the ILM with ILM blue dye. A half-moon shaped temporal ILM flap will be created, bridging the MH, using an end-gripping intraocular forceps. The posterior pole would be filled with perfluorocarbon (PFC) liquid and cohesive viscoelastic will be injected under the PFC to stabilize the ILM flap over the MH. Removal of PFC and search for peripheral retinal breaks will be done before removal of vitrectomy trocars and closure of sclerotomies wounds. Surgery will be combined with cataract removal (phacoemulsification) with intraocular lens implantation if patients have visually significant cataract. No specific post-operative posture will be required.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Macular hole closure rate | 3 months | Defined as closure of MH on optical coherence tomography (OCT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative best-corrected visual acuity | 12 months | BCVA |
| MH closure pattern | 12 months | Grading of MH closure pattern based on OCT |
Countries
Hong Kong
Contacts
PRINCIPAL_INVESTIGATORSimon KH Szeto, MBChB, FRCOphth
Chinese University of Hong Kong
Outcome results
None listed