Intraocular Gas Tamponade for Treatment of Large Idiopathic Macular Holes
NCT ID: NCT06927544
Last Updated: 2025-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
100 participants
INTERVENTIONAL
2025-02-01
2027-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Perfluoropropane (15% C3F8) gas tamponade
Macular hole surgery with ILM-peeling and 15% C3F8 gas tamponade
Pars plana vitrectomy
All operations are performed in a similar fashion using the vitrectomy system with 23-gauge and 25-gauge vitrectomy probes. Surgical approach and technique include the use of tissue-staining dyes, choice of endotamponade, and postoperative face-down positioning regimen.
Hexafluoride (20% SF6) gas tamponade
Macular hole surgery with ILM-peeling and hexafluoride (20% SF6) gas tamponade
Pars plana vitrectomy
All operations are performed in a similar fashion using the vitrectomy system with 23-gauge and 25-gauge vitrectomy probes. Surgical approach and technique include the use of tissue-staining dyes, choice of endotamponade, and postoperative face-down positioning regimen.
Interventions
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Pars plana vitrectomy
All operations are performed in a similar fashion using the vitrectomy system with 23-gauge and 25-gauge vitrectomy probes. Surgical approach and technique include the use of tissue-staining dyes, choice of endotamponade, and postoperative face-down positioning regimen.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Duration of Symptoms ≤ 12 months.
* Macular holes having a diameter 410-1000 μm.
* Informed consent.
Exclusion Criteria
* A patient who has already undergone treatment (surgery, laser etc.) for any disease of the retina.
* Traumatic or pediatric macular holes, and associated retinal detachment.
* History of any retinal disease such as high myopia, retinal dystrophies, central serous retinopathy, retinal vascular diseases, diabetic retinopathy, uveitis etc.
* Previous history of glaucoma or ocular hypertension.
* Failure to give informed consent.
50 Years
90 Years
ALL
No
Sponsors
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Ukrainian Vitreoretinal Society
OTHER
The Filatov Institute of Eye Diseases and Tissue Therapy
OTHER
Responsible Party
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Mykola Umanets
Mykola Umanets, MD, PhD, Head of Department of Retina and Vitreous Pathology SI "The Filatov Institute of Eye Diseases and Tissue Therapy", President of Ukrainian Vitreoretinal Society
Locations
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The Filatov Institute of Eye Diseases and Tissue Therapy
Odesa, , Ukraine
Countries
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Other Identifiers
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23/12/2024
Identifier Type: -
Identifier Source: org_study_id
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