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

NCT ID: NCT05223205

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-06
• Study Completion Date: 2023-06-06

Brief Summary

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.

Conditions

Macular Holes; Optical Coherence Tomography

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Air group

Air tamponade after vitrectomy.

Group Type: EXPERIMENTAL

Air

Intervention Type: PROCEDURE

Test if air is sufficient for macular hole closure.

SF6 group

10% SF6 tamponade after vitrectomy.

Group Type: EXPERIMENTAL

10% SF6 and 90% air

Intervention Type: PROCEDURE

Test if 10% SF6 and 90% air is sufficient for macular hole closure.

Interventions

Air

Test if air is sufficient for macular hole closure.

Intervention Type: PROCEDURE

10% SF6 and 90% air

Test if 10% SF6 and 90% air is sufficient for macular hole closure.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Ophthalmology

Graz, Styria, Austria

Countries

Austria

Other Identifiers

32-465 ex 19/20

Identifier Type: -

Identifier Source: org_study_id