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NCT Number: NCT06908824

No Endotamponade for Macular Hole Repair: the NEMAR Study

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hong Kong Eye Hospital, Hong Kong

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About this study

MH is a common macular condition that requires prompt surgical intervention to prevent irreversible vision loss. Conventional surgical repair of MH involves PPV, ILM peeling and gas tamponade followed by post-operative face down posturing. The use of gas tamponade, however, is associated with impairment of vision in the early post-operative period and restriction of air travel. Moreover, fluorinated ophthalmic gases are potent green house gases that contribute to global warming.

Recently, a novel surgical technique to repair MH without endotamponade has been proposed, termed the ILM flap with no gas tamponade technique.

There is currently no published randomised controlled trial comparing the efficacy and safety of MH repair using conventional surgical technique and the ILM flap with no gas tamponade technique.

Patients with confirmed full thickness MH on optical coherence tomography will be screened and invited to join the study. Written informed consent will be obtained. Baseline screening will be performed.

Recruited study participants will be randomly allocated to one of the two study groups:

  • Conventional surgery: Participants will undergo PPV, ILM peeling and gas tamponade to repair the MH. They would be instructed to adopt a face down posture for at least 5 days post-operatively.
  • ILM flap with no gas tamponade surgery: Participants will undergo PPV, ILM flap. No gas tampons would be required and there would be no restriction on post-operative posturing.

Participants will be instructed to attend post-operative follow up visits to undergo routine clinical examination, visual acuity checking and retinal imaging performed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

conventional surgery

Procedure

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.

ILM flap with no gas tamponade

Procedure

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.

Primary outcomes

  1. Macular hole closure rate

    Time frame: 3 months

    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).

Secondary outcomes

  1. Best Corrected Visual Acuity (BCVA) in the study eye

    Time frame: 12 months

    Best corrected visual acuity will be checked using the Snellen visual acuity chart

  2. Pattern of macular hole closure

    Time frame: 12 months

    The pattern of macular hole closure will be assessed on optical coherence tomography

  3. Rate of foveal gliosis

    Time frame: 12 months

    Based on optical coherence tomography.

  4. Patients reported visual function

    Time frame: 12 months

    The patient reported visual function will be assessed using the National Eye Institute 25-item visual function questionnaire (NEI VFQ-25).

    The score ranges from 0-100, with higher score indicating better visual function.

  5. Vision Preference Value Scale

    Time frame: 12 months

    Using a previously validated questionnaire to determine vision preference value and treatment preferences.

    Preference values were graded on a scale from 0 to 1, with 0 indicating death and 1 indicating perfect health with perfect vision.

  6. Metamorphosia score

    Time frame: 12 months

    Using M-CHARTS (Inami & Co., Ltd., Tokyo, Japan) Ranges from 0-10. 0 indicates no metamorphopsia and 10 indicates severe metamorphopsia.

Other outcomes

  1. Number of participants with surgery related adverse events

    Time frame: 12 months

    Include all post-operative complications, such as endophthalmitis, retinal detachment, re-opening of macular hole, intraocular pressure spike and hypotony.

  2. Retinal sensitivity

    Time frame: 12 months

    Microperimetry will be performed to assess the retinal sensitivity. This is an exploratory outcome and will be performed in selected patients only.

Study contacts

Contact information is provided by the study sponsor or research team.

Simon KH Dr Szeto, MBChB, MSc, FRCOphth

CONTACT

[email protected]

852 39435886

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Chang Gung University
  • Poznan University of Medical Sciences

Registry information

Official study title

The No Endotamponade for Macular Hole Repair (NEMAR) Study: An International Multi-center Randomized Controlled Trial Comparing Macular Hole Closure Using Internal Limiting Membrane Flap Without Endotamponade Versus Conventional Surgery

Acronym: NEMAR

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 3, 2025
Registry last updated
Sep 30, 2025

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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