Idiopathic Macular HoleNCT06927544
Intraocular Gas Tamponade for Treatment of Large Idiopathic Macular Holes
A study testing Pars plana vitrectomy in people with Idiopathic Macular Hole and Macular Hole, run by The Filatov Institute of Eye Diseases and Tissue Therapy at 1 site in Ukraine.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Idiopathic Macular Hole, Macular Hole, Macular Holes
- What is being tested?
- Pars plana vitrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUkraine
- Study dates
- 1 Feb 2025to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age 50 or above.
- Duration of Symptoms ≤ 12 months.
- Macular holes having a diameter 410-1000 μm.
- Informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ukraine1 site
The Filatov Institute of Eye Diseases and Tissue Therapy
Odesa, 65061
About this study
Official title: 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.
Read the 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.
- Being tested
- Pars plana vitrectomy
- Keywords
- macular hole, pars plana vitrectomy, perfluoropropane (C3F8), sulfur hexafluoride (SF6), Idiopathic Macular Hole, Full thickness macular hole, large macular hole, large macular holes
- Medical subject headings
- Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pars plana vitrectomyProcedure or surgery
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Perfluoropropane (15% C3F8) gas tamponade | Other | Macular hole surgery with ILM-peeling and 15% C3F8 gas tamponade Receives: Procedure: Pars plana vitrectomy |
| Hexafluoride (20% SF6) gas tamponade | Other | Macular hole surgery with ILM-peeling and hexafluoride (20% SF6) gas tamponade Receives: Procedure: Pars plana vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Closure of macular holes
Closure of macular hole evaluated on optical coherence tomography
Measured: 6 months
Type of macular hole closure
U-, V-, W-types of macular hole closure
Measured: 6 months
Secondary outcomes (1)
Best-corrected visual acuity
Visual acuity measured at last follow-up
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start1 Feb 2025
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Macular HoleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Filatov Institute of Eye Diseases and Tissue Therapy
- Sponsor type
- University, hospital or other
- Collaborators
- Ukrainian Vitreoretinal Society
- Responsible party
- Principal investigator, Mykola Umanets, The Filatov Institute of Eye Diseases and Tissue Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927544
- Sponsor's protocol ID
- 23/12/2024
- Status last verified
- Feb 2025
- First submitted
- 7 Apr 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Clinical Trial of Surgical Methods and Intraocular Gas Tamponade for Treatment of Large (410-1000 μm) Idiopathic Macular Holes
- ClinicalTrials.gov ID
- NCT06927544
- Acronym / sponsor ID
- 23/12/2024
- Keywords
- macular hole, pars plana vitrectomy, perfluoropropane (C3F8), sulfur hexafluoride (SF6), Idiopathic Macular Hole, Full thickness macular hole, large macular hole, large macular holes
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Filatov Institute of Eye Diseases and Tissue TherapyUniversity, hospital or other
- Collaborators
- Ukrainian Vitreoretinal Society
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perfluoropropane (15% C3F8) gas tamponade | Other | Procedure: Pars plana vitrectomyMacular hole surgery with ILM-peeling and 15% C3F8 gas tamponade |
| Hexafluoride (20% SF6) gas tamponade | Other | Procedure: Pars plana vitrectomyMacular hole surgery with ILM-peeling and hexafluoride (20% SF6) gas tamponade |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient age 50 or above.
- Duration of Symptoms ≤ 12 months.
- Macular holes having a diameter 410-1000 μm.
- Informed consent.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pars plana vitrectomyAlso: PPVAll 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. | Procedure or surgery | Hexafluoride (20% SF6) gas tamponade, Perfluoropropane (15% C3F8) gas tamponade |
Primary outcome
Closure of macular holes
Time frame: 6 months
Closure of macular hole evaluated on optical coherence tomography
Type of macular hole closure
Time frame: 6 months
U-, V-, W-types of macular hole closure
1 secondary outcome
Best-corrected visual acuity
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pars plana vitrectomy in people with Idiopathic Macular Hole and Macular Hole, run by The Filatov Institute of Eye Diseases and Tissue Therapy at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Closure of macular holes (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.