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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

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
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Holes

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 24, 2022
Last Updated
September 12, 2023
Sponsor
Medical University of Graz
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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

Learn more about this trial

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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