Intraocular Gas Tamponade for Treatment of Large Idiopathic Macular Holes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pars plana vitrectomy.
- Who it may be relevant to
- Registry conditions: Idiopathic Macular Hole, Macular Hole, Macular Holes, Full Thickness Macular Hole. Basic parameters: 50 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ukraine
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomised Clinical Trial of Surgical Methods and Intraocular Gas Tamponade for Treatment of Large (410-1000 μm) Idiopathic Macular Holes
Overview
The goal of this clinical trial is to evaluate the visual and anatomical outcomes of large (410-1000 μm) full-thickness macular holes repair surgery using perfluoropropane (15% C3F8), sulfur hexafluoride (20% SF6) gas tamponade.
Detailed description
The project is a randomized clinical trial with a follow up time of 6 months comparing the effects of surgical treatment of large (410-1000 μm) idiopathic macular holes. Patients are randomized to vitrectomy surgery with internal limiting membrane peeling using perfluoropropane (15% C3F8), sulfur hexafluoride (20% SF6) gas tamponad. Intra- and postoperative complications are registered.
Interventions
- Procedure 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.
Primary outcome measures
- Closure of macular holes [Time frame: 6 months]
- Type of macular hole closure [Time frame: 6 months]
Secondary outcome measures (1)
- Best-corrected visual acuity [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Patient age 50 or above.
- Duration of Symptoms ≤ 12 months.
- Macular holes having a diameter 410-1000 μm.
- Informed consent.
Exclusion criteria
- Patients under 50 years of age.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Ukraine · 1 center
- The Filatov Institute of Eye Diseases and Tissue Therapy — Odesa
Identifiers
NCT: NCT06927544 · 23/12/2024