An interventional study of Pars plana vitrectomy in Idiopathic Macular Hole, Macular Hole and Macular Holes, sponsored by The Filatov Institute of Eye Diseases and Tissue Therapy. Enrolling by invitation at 1 site in Ukraine. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-04-17.
Sponsored by The Filatov Institute of Eye Diseases and Tissue Therapy · Not applicable, Interventional, and Treatment
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.
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.
139 studies on the registry are indexed under Retinal Perforations; 22 are open to participants now.
This study's planned enrollment of 100 is above the median of 50 across 94 interventional studies indexed under Retinal Perforations.
Browse Retinal Perforations studies →The Filatov Institute of Eye Diseases and Tissue Therapy is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Macular hole surgery with ILM-peeling and 15% C3F8 gas tamponade
Procedure: Pars plana vitrectomy
Macular hole surgery with ILM-peeling and hexafluoride (20% SF6) gas tamponade
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.
Also known as: PPV
Closure of macular holes
Closure of macular hole evaluated on optical coherence tomography
Time frame: 6 months
Type of macular hole closure
U-, V-, W-types of macular hole closure
Time frame: 6 months
Best-corrected visual acuity
Visual acuity measured at last follow-up
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The Filatov Institute of Eye Diseases and Tissue Therapy