No Endotamponade for Macular Hole Repair: the NEMAR Study

NARecruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

September 16, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
Macular HoleMacular Hole Surgery
Interventions
PROCEDURE

Conventional 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.

PROCEDURE

ILM flap with no gas tamponade

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.

Trial Locations (3)

Unknown

RECRUITING

Hong Kong Eye Hospital, Hong Kong

NOT_YET_RECRUITING

Poznan University of Medical Sicences, University Hospital in Poznan, Poznan

NOT_YET_RECRUITING

Chang Gung Memorial Hospital, Taoyuan District

All Listed Sponsors
collaborator

Poznan University of Medical Sciences

OTHER

collaborator

Chang Gung University

OTHER

lead

Chinese University of Hong Kong

OTHER

NCT06908824 - No Endotamponade for Macular Hole Repair: the NEMAR Study | Biotech Hunter | Biotech Hunter