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NCT Number: NCT07129798

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Macular Hole Eye Diseases Myopia Refractive Errors Retinal Diseases Retinal Perforations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hong Kong Eye Hospital

Kowloon, Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ILM flap with no endotamponade technique

Procedure

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.

Primary outcomes

  1. Macular hole closure rate

    Time frame: 3 months

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

Secondary outcomes

  1. Post-operative best-corrected visual acuity

    Time frame: 12 months

    BCVA

  2. MH closure pattern

    Time frame: 12 months

    Grading of MH closure pattern based on OCT

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2025
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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