Intraocular Gas Tamponade for Treatment of Large Idiopathic Macular Holes

NCT06927544 | Enrolling By Invitation DMC

• 1 other identifier: 23/12/2024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

macular hole; pars plana vitrectomy; perfluoropropane (C3F8); sulfur hexafluoride (SF6); Idiopathic Macular Hole; Full thickness macular hole; large macular hole; large macular holes

Outcome Measures

Primary Outcomes (2)

• Closure of macular holes

  Closure of macular hole evaluated on optical coherence tomography

  6 months

• Type of macular hole closure

  U-, V-, W-types of macular hole closure

  6 months

Secondary Outcomes (1)

• Best-corrected visual acuity

  6 months

Study Arms (2)

Perfluoropropane (15% C3F8) gas tamponade

OTHER

Macular hole surgery with ILM-peeling and 15% C3F8 gas tamponade

Procedure: Pars plana vitrectomy

Hexafluoride (20% SF6) gas tamponade

OTHER

Macular hole surgery with ILM-peeling and hexafluoride (20% SF6) gas tamponade

Procedure: Pars plana vitrectomy

Interventions

Pars plana vitrectomy PROCEDURE

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

Hexafluoride (20% SF6) gas tamponade; Perfluoropropane (15% C3F8) gas tamponade

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age 50 or above.
• Duration of Symptoms ≤ 12 months.
• Macular holes having a diameter 410-1000 μm.
• Informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Filatov Institute of Eye Diseases and Tissue Therapy: lead
• Ukrainian Vitreoretinal Society: collaborator

Study Sites (1)

The Filatov Institute of Eye Diseases and Tissue Therapy

Odesa, 65061, Ukraine

Location

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 15, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)