NCT06927544

Intraocular Gas Tamponade for Treatment of Large Idiopathic Macular Holes

A Randomised Clinical Trial of Surgical Methods and Intraocular Gas Tamponade for Treatment of Large (410-1000 μm) Idiopathic Macular Holes

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: The Filatov Institute of Eye Diseases and Tissue Therapy · Academic / Other
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Idiopathic Macular Hole
• Macular Hole
• Macular Holes
• Full Thickness Macular Hole

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-02-01
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2025-04-15
• Last updated: 2025-04-17

Locations

1 site across 1 country: Ukraine