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

NCT07129798 | Active Not Recruiting

• 1 other identifier: KC/KE-23-0115/ER-4
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia; Macular Hole

Keywords

Macular hole; High Myopia; Vitrectomy; Internal limiting membrane flap; No endotamponade

Outcome Measures

Primary Outcomes (1)

• Macular hole closure rate

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

  3 months

Secondary Outcomes (2)

• Post-operative best-corrected visual acuity

  12 months

• MH closure pattern

  12 months

Study Arms (1)

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.

Procedure: ILM flap with no endotamponade technique

Interventions

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.

ILM flap with no endotamponade technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Hong Kong Eye Hospital

Kowloon, Hong Kong

Location

Related Publications (3)

• Szeto SKH, Yu AHY, Tsang CW, Mohamed S, Chen LJ, Lai TYY. COMPLEX MACULAR HOLE CLOSURE BY TEMPORAL INTERNAL LIMITING MEMBRANE FLAP WITHOUT ENDOTAMPONADE. Retina. 2024 Nov 1;44(11):1915-1922. doi: 10.1097/IAE.0000000000004201.

  PMID: 39436300 BACKGROUND

• Szeto SKH, Lam JTW, Yu AHY, Pang CMK, Lin TPH, Hui VWK, Tsang KK, Chan JCK, Chen LJ, Lai TYY, Mohamed S, Tsang CW. Macular Hole Closure by Internal Limiting Membrane Flap without Gas Tamponade versus Conventional Surgery: A Comparative Study. Ophthalmol Retina. 2025 Nov;9(11):1034-1043. doi: 10.1016/j.oret.2025.06.005. Epub 2025 Jun 13.

  PMID: 40518116 BACKGROUND

• Stopa M, Ciesielski M, Rakowicz P. Macular Hole Closure Without Endotamponade Application. Retina. 2023 Apr 1;43(4):688-691. doi: 10.1097/IAE.0000000000002850. Epub 2020 May 25.

  PMID: 32453068 BACKGROUND

MeSH Terms

Conditions

Retinal Perforations; Myopia

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Refractive Errors

Study Officials

• Simon KH Szeto, MBChB, FRCOphth

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 19, 2025
• Study Start: January 18, 2024
• Primary Completion (Estimated): December 24, 2026
• Study Completion (Estimated): December 26, 2026
• Last Updated: March 18, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)