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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

NCT06927544•The Filatov Institute of Eye Diseases and Tissue Therapy

View on ClinicalTrials.gov

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.

Eligibility

Age

50 - 90 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

The Filatov Institute of Eye Diseases and Tissue Therapy

Odesa, Ukraine

Key Dates

Start Date

February 1, 2025

Primary Completion Date

February 1, 2027

Completion Date

February 1, 2027

Last Updated

April 17, 2025

Enrollment

100

ESTIMATED participants

Conditions

Idiopathic Macular HoleMacular HoleMacular HolesFull Thickness Macular Hole

Interventions

Pars plana vitrectomy

PROCEDURE

The Use of Amniotic Membrane or Internal Limiting Membrane for Large or Refractory Macular Holes: A Prospective Study

NCT04904679

Macular Holes

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ACTIVE_NOT_RECRUITING

Subjective Pain Scoring for Subtenonal Anesthesia During Vitrectomy

NCT06830070

Epiretinal MembranesRetinal Detachment+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Intraocular Gas Tamponade for Treatment of Large Idiopathic Macular Holes

Inclusion Criteria

Exclusion Criteria

The Use of Amniotic Membrane or Internal Limiting Membrane for Large or Refractory Macular Holes: A Prospective Study

Subjective Pain Scoring for Subtenonal Anesthesia During Vitrectomy

UNITY VCS Vitreoretinal Surgery

Analysis of Novel Positioning Sensor-assisted Postoperative Position Correction and Effective Prone Time Recorded in Patients With Different Prone Times After Macular Hole Surgery

ILM Peeling Versus Inverted Flap Technique for Treatment of Macular Hole: Near Visual Acuity Outcomes

Effect of the Membrane Blue Dual® Dye on the Retinal Sensitivity in Macular Hole Surgery