Optical Coherence Tomography Angiography Characteristics of Patients With Surgically Closed Full-thickness Idiopathic Macular Holes < 600 μm With Air Versus 10% SF6 Tamponade

Medical University of Graz

Status

Completed

Conditions

Optical Coherence Tomography

Macular Holes

Treatments

Procedure: Air

Procedure: 10% SF6 and 90% air

Study type

Interventional

Funder types

Other

Identifiers

NCT05223205

32-465 ex 19/20

Details and patient eligibility

About

State of the art treatment for idiopathic macular holes consists of pars plana vitrectomy, internal limiting membrane staining with a blue colouring dye, internal limiting membrane peeling and filling of the vitrectomized space with a specific tamponade such as air and SF6. Air and SF6 have previously shown similar closure rates, although there was a trend towards lower closure rates in large diameter IMH (Idiopathic Macular Holes) using air. IMH with diameters < 600 μm are currently believed to have similar closure rates with air and SF6. The investigators want to assess possible effects of the used tamponade (air or SF6) on closure rates and perfusion parameters represented by OCTA (Optical coherence tomography angiography). IMH eyes with a minimum diameter > 600 μm will be excluded. Two idiopathic macular hole patient groups will therefore be formed: The first group (group 1) will receive air after vitrectomy and membrane peeling, the second group (group 2) will receive 10% SF6 (and 90% air) after vitrectomy and membrane peeling. After recruitment, patients will therefore be electronically randomized to one of the two groups. The groups will then be compared by the means of OCT (Optical coherence tomography) and OCTA.

Note: The trial was registered retrospectively on Clinicaltrials.gov after start of recruitment.

Enrollment

40 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient must be able and willing to give informed consent.
Patient must be between 18 and 100 years of age.
Patient must not have any significant media opacity which interferes with the examination.
Patient must have an (stage 1-4) idiopathic macular hole requiring surgery.

Exclusion criteria

Unwilling or unable to provide informed consent
Under 18 or over 100 years of age
Significant media opacities
Systemic pathologies making an examination difficult or cumbersome to the patient
Primary and/or secondary epiretinal membranes (ERM), except incipient ERMs not affecting the foveal contour and not requiring surgery
Full-thickness idiopathic macular hole > 600 μm in minimum diameter
Nonclosure
Lamellar holes not requiring surgery
Pseudo holes
Glaucoma
Diabetes
Anisometropia > 2 diopters
High myopia (spherical equivalent > 6 diopters and/or axial length > 26 mm
Other retinal or ophthalmic pathologies except moderate cataract
OCTA scan signal strength < 5
Low image quality
Failure of automatic layer segmentation