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Completed

NCT Number: NCT05223205

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

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.

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Key information

Conditions

Macular Holes Eye Diseases Optical Coherence Tomography Retinal Diseases Retinal Perforations

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology

Graz, Styria, 8036, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

air

Procedure

Test if air is sufficient for macular hole closure.

10% SF6 and 90% air

Procedure

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

Primary outcomes

  1. Macular hole closure

    Time frame: 2 weeks

Secondary outcomes

  1. Foveal avascular zone area

    Time frame: 3 months

  2. Parafoveal vessel density

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 3, 2022
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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