Intraocular Gas Tamponade for Treatment of Large Idiopathic Macular Holes

NCT06927544 — Not applicable, Enrolling by invitation, 100 participants, The Filatov Institute of Eye Diseases and Tissue Therapy

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

Registry	NCT06927544
Status	Enrolling by invitation
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	100 (Estimated)
Sponsor	The Filatov Institute of Eye Diseases and Tissue Therapy (Other); collaborators: Ukrainian Vitreoretinal Society
Conditions	Idiopathic Macular Hole, Macular Hole, Macular Holes, Full Thickness Macular Hole
Interventions	Pars plana vitrectomy (Procedure)
Dates	start 2025-02-01, primary completion 2027-02-01 (estimated), completion 2027-02-01 (estimated), first posted 2025-04-15, last updated 2025-04-17
Locations	1 site in Ukraine

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Perfluoropropane (15% C3F8) gas tamponade	Other	Procedure: Pars plana vitrectomy	Macular hole surgery with ILM-peeling and 15% C3F8 gas tamponade
Hexafluoride (20% SF6) gas tamponade	Other	Procedure: Pars plana vitrectomy	Macular hole surgery with ILM-peeling and hexafluoride (20% SF6) gas tamponade

Pars plana vitrectomy (Procedure), also known as PPV: 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.

+Outcome measures

Primary outcomes

Closure of macular holes [6 months]: Closure of macular hole evaluated on optical coherence tomography
Type of macular hole closure [6 months]: U-, V-, W-types of macular hole closure

Secondary outcomes

Best-corrected visual acuity [6 months]: Visual acuity measured at last follow-up

+Eligibility

Sex: All, ages: 50 Years to 90 Years

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)

Facility	City	Country	Status
The Filatov Institute of Eye Diseases and Tissue Therapy	Odesa	Ukraine