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Enrolling by Invitation

NCT Number: NCT06927544

Intraocular Gas Tamponade for Treatment of Large Idiopathic Macular Holes

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.

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Key information

Conditions

Idiopathic Macular Hole Eye Diseases Full Thickness Macular Hole Macular Hole Macular Holes Retinal Diseases Retinal Perforations

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Filatov Institute of Eye Diseases and Tissue Therapy

Odesa, 65061, Ukraine

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: PPV

Primary outcomes

  1. Closure of macular holes

    Time frame: 6 months

    Closure of macular hole evaluated on optical coherence tomography

  2. Type of macular hole closure

    Time frame: 6 months

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

Secondary outcomes

  1. Best-corrected visual acuity

    Time frame: 6 months

    Visual acuity measured at last follow-up

Sponsors and collaborators

Lead sponsor

The Filatov Institute of Eye Diseases and Tissue Therapy

Other

Collaborators

  • Ukrainian Vitreoretinal Society

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 15, 2025
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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