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

NCT05223205 | Completed

• 1 other identifier: 32-465 ex 19/20
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Macular hole closure

  2 weeks

Secondary Outcomes (2)

• Foveal avascular zone area

  3 months

• Parafoveal vessel density

  3 months

Study Arms (2)

Air group

EXPERIMENTAL

Air tamponade after vitrectomy.

Procedure: Air

SF6 group

EXPERIMENTAL

10% SF6 tamponade after vitrectomy.

Procedure: 10% SF6 and 90% air

Interventions

Air PROCEDURE

Test if air is sufficient for macular hole closure.

Air group

10% SF6 and 90% air PROCEDURE

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

SF6 group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Department of Ophthalmology

Graz, Styria, 8036, Austria

Location

MeSH Terms

Conditions

Retinal Perforations

Interventions

Air

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 3, 2022
• Study Start: July 6, 2020
• Primary Completion: February 6, 2023
• Study Completion: June 6, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

AU (1)