NCT06908824

Brief Summary

Full-thickness macular hole (MH) is a common sight threatening macular condition with a prevalence of 3.3 per 1000 individuals. Prompt surgical repair of MH is imperative in preventing irreversible vision loss from MH as the majority of patients would experience progressive loss of central vision, often resulting in visual acuity (VA) of 20/200 or worse and the spontaneous closure rate is less than 10%. Pars plana vitrectomy (PPV) with internal limiting membrane (ILM) peeling (with or without ILM flap) and gas tamponade, herein referred to as conventional surgery, is the current standard-of-care surgical technique in repairing MH. Recently, a novel surgical technique that omits the need of gas tamponade to repair MH has been proposed, early results from retrospective studies were encouraging. The purpose of this prospective international multi-centre randomised controlled study is to compare the efficacy and safety of two surgical techniques in treating MH:

  1. 1.Conventional surgery: PPV with ILM peeling and gas or silicone oil tamponade
  2. 2.ILM flap with no gas tamponade surgery: PPV with ILM flap with no gas tamponade

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
3 countries

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Sep 2025Dec 2027

First Submitted

Initial submission to the registry

March 24, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 3, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

September 16, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

September 30, 2025

Status Verified

August 1, 2025

Enrollment Period

2.3 years

First QC Date

March 24, 2025

Last Update Submit

September 26, 2025

Conditions

Macular HoleMacular Hole Surgery

Keywords

Macular HoleVitrectomyMacular surgeryInternal limiting membrane peelingGas tamponade

Outcome Measures

Primary Outcomes (1)

  • Macular hole closure rate

    The primary outcome is the macular hole closure rate without additional vitrectomy/macular surgery at post-operative month 3. Closure of macular hole is defined as the presence of continuous retinal tissue over the retinal pigment epithelium (RPE) without bare RPE exposed to vitreous cavity on optical coherence tomography (OCT).

    3 months

Secondary Outcomes (6)

  • Best Corrected Visual Acuity (BCVA) in the study eye

    12 months

  • Pattern of macular hole closure

    12 months

  • Rate of foveal gliosis

    12 months

  • Patients reported visual function

    12 months

  • Vision Preference Value Scale

    12 months

  • +1 more secondary outcomes

Other Outcomes (2)

  • Number of participants with surgery related adverse events

    12 months

  • Retinal sensitivity

    12 months

Study Arms (2)

Conventional surgery

ACTIVE COMPARATOR

Patients would undergo conventional surgery to repair macular hole and be instructed to adopt a face-down posturing in the first 5 days following operation.

Procedure: Conventional surgery

Internal limiting membrane (ILM) flap with no gas tamponade

EXPERIMENTAL

Patients would undergo macular hole repair by the ILM flap with no gas tamponade technique. Patients will be instructed to avoid excessive movement and adopt a sit up/supine posture for the first 24 hours, beyond which there will be no posturing restriction.

Procedure: ILM flap with no gas tamponade

Interventions

Conventional surgeryPROCEDURE

Pars plana vitrectomy (PPV) with temporal internal limiting membrane (ILM) flap would be performed. Perfluorocarbon liquid (PFCL) or viscoelastic may be used as an adjunct. Air/Fluid exchange would be performed at the end of surgery, further exchange of air with 8-14% octafluoropropane (C3F8) would be performed based on operating surgeon's discretion. In cases a temporal ILM flap could not be created, an ILM flap would be created from other quadrants, for example, a nasal ILM would be created instead. Patients with visually significant cataract may undergo concomitant phacoemulsification and intraocular lens implantation or deferred to post-operative month 6-12. Patients would be instructed to adopt a face-down posturing in the first 5 days following operation.

Conventional surgery
ILM flap with no gas tamponadePROCEDURE

Pars plana vitrectomy with temporal internal limiting membrane (ILM) flap would be performed. The ILM flap would be stabilised over the macular hole using perfluorocarbon liquid (PFCL) followed by sub-PFCL dispersive viscoelastic injection. The PFCL would be removed towards the end of surgery. In cases a temporal ILM flap could not be created, an ILM flap would be created from other quadrants, for example, a nasal ILM would be created instead. Concomitant phacoemulsification and intraocular lens implantation would be performed in patients with visually significant cataract or deferred to post-operative month 6-12. Patients will be instructed to avoid excessive movement and adopt a face forward/ supine position for first 24 hours. Afterwards, there would be no restriction on post-operative posturing.

Internal limiting membrane (ILM) flap with no gas tamponade

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>= 18 years
  • Presence of full thickness macular hole in one eye (defined as full thickness discontinuity of neuro-sensory retina at the macula on optical coherence tomography)
  • Able to comply to post-operative posture
  • VA ≥0.05 and ≤0.8

You may not qualify if:

  • Fellow eye enrolled in the study
  • Eyes that underwent previous macular surgery
  • Presence of maculopathy other than macular hole, epi-retinal membrane or myopic maculopathy. For example, age-related macular degeneration, diabetic macular edema or pre-existing macular scar
  • Axial length \>/= 28mm or presence of significant myopic chorio-retinal atrophy involving the fovea
  • Minimum linear diameter \>/=800µm
  • Presence of contraindications to intraocular gas, such as advanced glaucoma or uncontrolled glaucoma
  • Significant macular puckering (Govetto staging ≥ stage 2)
  • Patients who are unable to give informed consent
  • Patients who are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hong Kong Eye Hospital

Hong Kong, Hong Kong

RECRUITING

Poznan University of Medical Sicences, University Hospital in Poznan

Poznan, Poland

NOT YET RECRUITING

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

NOT YET RECRUITING

Related Publications (5)

  • Wada I, Yoshida S, Kobayashi Y, Zhou Y, Ishikawa K, Nakao S, Hisatomi T, Ikeda Y, Ishibashi T, Sonoda KH. Quantifying metamorphopsia with M-CHARTS in patients with idiopathic macular hole. Clin Ophthalmol. 2017 Sep 20;11:1719-1726. doi: 10.2147/OPTH.S144981. eCollection 2017.

    PMID: 29033537BACKGROUND

  • Linz MO, Bressler NM, Chaikitmongkol V, Sivaprasad S, Patikulsila D, Choovuthayakorn J, Watanachai N, Kunavisarut P, Menon D, Tadarati M, Delalibera Pacheco K, Sanyal A, Scott AW. Vision Preference Value Scale and Patient Preferences in Choosing Therapy for Symptomatic Vitreomacular Interface Abnormality. JAMA Ophthalmol. 2018 Jun 1;136(6):658-664. doi: 10.1001/jamaophthalmol.2018.1272.

    PMID: 29800983BACKGROUND

  • Chan CW, Wong D, Lam CL, McGhee S, Lai WW. Development of a Chinese version of the National Eye Institute Visual Function Questionnaire (CHI-VFQ-25) as a tool to study patients with eye diseases in Hong Kong. Br J Ophthalmol. 2009 Nov;93(11):1431-6. doi: 10.1136/bjo.2009.158428. Epub 2009 Jun 9.

    PMID: 19515645BACKGROUND

  • 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: 32453068BACKGROUND

  • 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: 39436300BACKGROUND

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Simon KH Szeto, MBChB, FRCOphth

    Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon KH Dr Szeto, MBChB, MSc, FRCOphth

CONTACT

852 39435886simonkhszeto@cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

March 24, 2025

First Posted

April 3, 2025

Study Start

September 16, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

September 30, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)HK(1)PL(1)