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

Optical Coherence Tomography Angiography (AngioVue™, Optovue Inc., Fremont, Calif., USA) Characteristics of Patients With Surgically Closed Full-thickness Idiopathic Macular Holes < 600 μm With Air Versus 10% SF6 Tamponade - a Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Macular Holes; Optical Coherence Tomography
• Intervention / Treatment: Procedure: Air; Procedure: 10% SF6 and 90% air

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8036
      • Department of Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Air group; Air tamponade after vitrectomy.	Procedure: Air; Test if air is sufficient for macular hole closure.
Experimental: SF6 group; 10% SF6 tamponade after vitrectomy.	Procedure: 10% SF6 and 90% air; Test if 10% SF6 and 90% air is sufficient for macular hole closure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Macular hole closure	2 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Foveal avascular zone area	3 months
Parafoveal vessel density	3 months

Collaborators and Investigators

• Sponsor: Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2020
• Primary Completion (Actual): February 6, 2023
• Study Completion (Actual): June 6, 2023

Study Registration Dates

• First Submitted: January 24, 2022
• First Submitted That Met QC Criteria: January 24, 2022
• First Posted (Actual): February 3, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Perforations
• Other Study ID Numbers: 32-465 ex 19/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No