Intraocular Gas Tamponade for Treatment of Large Idiopathic Macular Holes

April 14, 2025 updated by: Mykola Umanets, The Filatov Institute of Eye Diseases and Tissue Therapy

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ukraine
      • Odesa, Ukraine, 65061
        • The Filatov Institute of Eye Diseases and Tissue Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Perfluoropropane (15% C3F8) gas tamponade
Macular hole surgery with ILM-peeling and 15% C3F8 gas tamponade
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.
Other Names:
  • PPV
Other: Hexafluoride (20% SF6) gas tamponade
Macular hole surgery with ILM-peeling and hexafluoride (20% SF6) gas tamponade
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.
Other Names:
  • PPV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Closure of macular holes
Time Frame: 6 months
Closure of macular hole evaluated on optical coherence tomography
6 months
Type of macular hole closure
Time Frame: 6 months
U-, V-, W-types of macular hole closure
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best-corrected visual acuity
Time Frame: 6 months
Visual acuity measured at last follow-up
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Filatov Institute of Eye Diseases and Tissue Therapy

Collaborators

Ukrainian Vitreoretinal Society

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

April 7, 2025

First Submitted That Met QC Criteria

April 14, 2025

First Posted (Actual)

April 15, 2025

Study Record Updates

Last Update Posted (Actual)

April 17, 2025

Last Update Submitted That Met QC Criteria

April 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23/12/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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