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Intraocular Gas Tamponade for Treatment of Large Idiopathic Macular Holes

NCT06927544 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-04-17

No results posted yet for this study

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.

Conditions

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

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.

Sponsors & Collaborators

  • Ukrainian Vitreoretinal Society

    collaborator OTHER

  • The Filatov Institute of Eye Diseases and Tissue Therapy

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2027-02-01
Completion
2027-02-01

Countries

  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06927544 on ClinicalTrials.gov