Macular Holes Clinical Trial
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
Verified date | September 2023 |
Source | Medical University of Graz |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | June 6, 2023 |
Est. primary completion date | February 6, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Austria | Department of Ophthalmology | Graz | Styria |
Lead Sponsor | Collaborator |
---|---|
Medical University of Graz |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Macular hole closure | 2 weeks | ||
Secondary | Foveal avascular zone area | 3 months | ||
Secondary | Parafoveal vessel density | 3 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03713268 -
Intraoperative OCT Guidance of Intraocular Surgery II
|
||
Completed |
NCT04535622 -
Efficacy of Exercise Program for Facedown Posture-related Pain After Retinal Surgery
|
N/A | |
Completed |
NCT03572725 -
Air Tamponade and Non-supine Positioning in Macular Hole Surgery.
|
N/A | |
Completed |
NCT01471912 -
Elongation of Foveal Tissue After Macular Hole Surgery
|
N/A | |
Completed |
NCT03646695 -
ILM Flap Transposition Versus ILM Peeling for Macular Holes: a Pilot Study
|
N/A | |
Completed |
NCT06323902 -
Autologous Platelet-rich Plasma as a Treatment for Macular Holes
|
||
Completed |
NCT01974310 -
Postoperative Positioning After Surgery for Macular Holes
|
N/A | |
Completed |
NCT00537992 -
Blue-Blocking IOLs in Combined Surgery
|
N/A | |
Completed |
NCT05171621 -
Measuring Subjective Quality of Vision and Metamorphopsia Before and After Epiretinal Membrane and Macular Hole Surgery
|
||
Recruiting |
NCT06000111 -
Duration of Face Down Positioning for Full-Thickness Macular Hole Repair
|
N/A | |
Recruiting |
NCT04135638 -
Inverted ILM-flap Techniques Variants for Macular Hole Surgery: Outcomes Comparison
|
N/A | |
Completed |
NCT03525899 -
Macular Hole After Diabetic Vitrectomy
|
||
Completed |
NCT03917602 -
Human Amniotic Membrane Plug for Large Macular Holes
|
N/A | |
Completed |
NCT04527848 -
Comparison of Two Intraocular Gas Injection Techniques in Macula Hole Surgery
|
Phase 4 | |
Recruiting |
NCT04116892 -
Comparative Analysis of Large Macular Hole Surgeries
|
N/A | |
Completed |
NCT01229657 -
Evaluation of Anatomic and Visual Outcomes of Initially Closed Macular Holes
|
N/A | |
Completed |
NCT01306487 -
Observation of Recovery of Foveal Cone Microstructures After Macular Hole Surgery
|
N/A | |
Completed |
NCT01381965 -
Foveal Cone Outer Segment Resumption to Predict Visual Recovery After Macular Hole Surgery
|
N/A | |
Completed |
NCT03174639 -
High Myopia Macular Hole and Retinal Detachment Treated With Double ILM Flaps
|
N/A | |
Recruiting |
NCT05083650 -
Large Macular Hole Closure Rate With Amniotic Membrane Graft With and Without Limitorrhexis
|
N/A |