No Endotamponade for Macular Hole Repair: the NEMAR Study

ConditionsMacular Hole Macular Hole Surgery

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorChinese University of Hong Kong

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Conventional surgery
Procedure/Surgery
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/Surgery
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.

Treatment groups

180 Participants

are divided into 2 treatment groups

Group A: Conventional surgeryActive comparator 1 intervention

Group B: Internal limiting membrane (ILM) flap with no gas tamponadeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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).

Time frame

3 months

Secondary outcomes

Best Corrected Visual Acuity (BCVA) in the study eye

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

Time frame

12 months

Pattern of macular hole closure

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

Time frame

12 months

Rate of foveal gliosis

Based on optical coherence tomography.

Time frame

12 months

Patients reported visual function

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.

Time frame

12 months

Other outcomes

Number of participants with surgery related adverse events

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

Time frame

12 months

Retinal sensitivity

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

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese University of Hong Kong

Lead sponsor

Poznan University of Medical Sciences

Collaborator

Chang Gung University

Collaborator

Source ClinicalTrials.gov

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