Optical Coherence Tomography Angiography Characteristics of Patients With Surgically Closed Full-thickness Idiopathic Macular Holes < 600 μm With Air Versus 10% SF6 Tamponade
Primary Purpose
Macular Holes, Optical Coherence Tomography
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Air
10% SF6 and 90% air
Sponsored by
About this trial
This is an interventional treatment trial for Macular Holes
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
Sites / Locations
- Department of Ophthalmology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Air group
SF6 group
Arm Description
Air tamponade after vitrectomy.
10% SF6 tamponade after vitrectomy.
Outcomes
Primary Outcome Measures
Macular hole closure
Secondary Outcome Measures
Foveal avascular zone area
Parafoveal vessel density
Full Information
NCT ID
NCT05223205
First Posted
January 24, 2022
Last Updated
September 12, 2023
Sponsor
Medical University of Graz
1. Study Identification
Unique Protocol Identification Number
NCT05223205
Brief Title
Optical Coherence Tomography Angiography Characteristics of Patients With Surgically Closed Full-thickness Idiopathic Macular Holes < 600 μm With Air Versus 10% SF6 Tamponade
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 6, 2020 (Actual)
Primary Completion Date
February 6, 2023 (Actual)
Study Completion Date
June 6, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Holes, Optical Coherence Tomography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Air group
Arm Type
Experimental
Arm Description
Air tamponade after vitrectomy.
Arm Title
SF6 group
Arm Type
Experimental
Arm Description
10% SF6 tamponade after vitrectomy.
Intervention Type
Procedure
Intervention Name(s)
Air
Intervention Description
Test if air is sufficient for macular hole closure.
Intervention Type
Procedure
Intervention Name(s)
10% SF6 and 90% air
Intervention Description
Test if 10% SF6 and 90% air is sufficient for macular hole closure.
Primary Outcome Measure Information:
Title
Macular hole closure
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Foveal avascular zone area
Time Frame
3 months
Title
Parafoveal vessel density
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Department of Ophthalmology
City
Graz
State/Province
Styria
ZIP/Postal Code
8036
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Optical Coherence Tomography Angiography Characteristics of Patients With Surgically Closed Full-thickness Idiopathic Macular Holes < 600 μm With Air Versus 10% SF6 Tamponade
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