Macular HolesNCT05223205
Optical Coherence Tomography Angiography Characteristics of Patients With Surgically Closed Full-thickness Idiopathic Macular Holes < 600 μm With Air Versus 10% SF6 Tamponade
A study testing Air and 10% SF6 and 90% air in people with Macular Holes and Optical Coherence Tomography, run by Medical University of Graz at 1 site in Austria.
Trial summary
State of the art treatment for idiopathic macular holes consists of pars plana vitrectomy, internal limiting membrane staining with a blue colouring dye, internal limiting membrane peeling and filling of the vitrectomized space with a specific tamponade such as air and SF6. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Macular Holes, Optical Coherence Tomography
- What is being tested?
- Air and 10% SF6 and 90% air
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 6 Jul 2020to 6 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must be able and willing to give informed consent.
- Patient must be between 18 and 100 years of age.
- Patient must not have any significant media opacity which interferes with the examination.
- Patient must have an (stage 1-4) idiopathic macular hole requiring surgery.
Who cannot join
- Unwilling or unable to provide informed consent
- Under 18 or over 100 years of age
- Significant media opacities
- Systemic pathologies making an examination difficult or cumbersome to the patient
- Primary and/or secondary epiretinal membranes (ERM), except incipient ERMs not affecting the foveal contour and not requiring surgery
- Full-thickness idiopathic macular hole > 600 μm in minimum diameter
Show all 17Show fewer
- Nonclosure
- Lamellar holes not requiring surgery
- Pseudo holes
- Glaucoma
- Diabetes
- Anisometropia > 2 diopters
- High myopia (spherical equivalent > 6 diopters and/or axial length > 26 mm
- Other retinal or ophthalmic pathologies except moderate cataract
- OCTA scan signal strength < 5
- Low image quality
- Failure of automatic layer segmentation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optical Coherence Tomography Angiography (AngioVue™, Optovue Inc., Fremont, Calif., USA) Characteristics of Patients With Surgically Closed Full-thickness Idiopathic Macular Holes < 600 μm With Air Versus 10% SF6 Tamponade - a Pilot Study
State of the art treatment for idiopathic macular holes consists of pars plana vitrectomy, internal limiting membrane staining with a blue colouring dye, internal limiting membrane peeling and filling of the vitrectomized space with a specific tamponade such as air and SF6. Air and SF6 have previously shown similar closure rates, although there was a trend towards lower closure rates in large diameter IMH (Idiopathic Macular Holes) using air. IMH with diameters < 600 μm are currently believed to have similar closure rates with air and SF6. The investigators want to assess possible effects of the used tamponade (air or SF6) on closure rates and perfusion parameters represented by OCTA (Optical coherence tomography angiography). IMH eyes with a minimum diameter > 600 μm will be excluded. Two idiopathic macular hole patient groups will therefore be formed: The first group (group 1) will receive air after vitrectomy and membrane peeling, the second group (group 2) will receive 10% SF6 (and 90% air) after vitrectomy and membrane peeling. After recruitment, patients will therefore be electronically randomized to one of the two groups. The groups will then be compared by the means of OCT (Optical coherence tomography) and OCTA.
Note: The trial was registered retrospectively on Clinicaltrials.gov after start of recruitment.
- Conditions
- Macular Holes, Optical Coherence Tomography
- Being tested
- Air, 10% SF6 and 90% air
- Medical subject headings
- Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AirProcedure or surgery
Test if air is sufficient for macular hole closure.
10% SF6 and 90% airProcedure or surgery
Test if 10% SF6 and 90% air is sufficient for macular hole closure.
| Study group | Role | What they receive |
|---|---|---|
| Air group | Experimental | Air tamponade after vitrectomy. Receives: Procedure: Air |
| SF6 group | Experimental | 10% SF6 tamponade after vitrectomy. Receives: Procedure: 10% SF6 and 90% air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular hole closure
Measured: 2 weeks
Secondary outcomes (2)
Foveal avascular zone area
Measured: 3 months
Parafoveal vessel density
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start6 Jul 2020
- Primary completion6 Feb 2023
- Study completion6 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular HolesStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223205
- Sponsor's protocol ID
- 32-465 ex 19/20
- Status last verified
- Sep 2023
- First submitted
- 24 Jan 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Angiography (AngioVue™, Optovue Inc., Fremont, Calif., USA) Characteristics of Patients With Surgically Closed Full-thickness Idiopathic Macular Holes < 600 μm With Air Versus 10% SF6 Tamponade - a Pilot Study
- ClinicalTrials.gov ID
- NCT05223205
- Acronym / sponsor ID
- 32-465 ex 19/20
- Conditions
- Macular Holes, Optical Coherence Tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 6 Feb 2023 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 3 Feb 2022 (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.
State of the art treatment for idiopathic macular holes consists of pars plana vitrectomy, internal limiting membrane staining with a blue colouring dye, internal limiting membrane peeling and filling of the vitrectomized space with a specific tamponade such as air and SF6. Air and SF6 have previously shown similar closure rates, although there was a trend towards lower closure rates in large diameter IMH (Idiopathic Macular Holes) using air. IMH with diameters < 600 μm are currently believed to have similar closure rates with air and SF6. The investigators want to assess possible effects of the used tamponade (air or SF6) on closure rates and perfusion parameters represented by OCTA (Optical coherence tomography angiography). IMH eyes with a minimum diameter > 600 μm will be excluded. Two idiopathic macular hole patient groups will therefore be formed: The first group (group 1) will receive air after vitrectomy and membrane peeling, the second group (group 2) will receive 10% SF6 (and 90% air) after vitrectomy and membrane peeling. After recruitment, patients will therefore be electronically randomized to one of the two groups. The groups will then be compared by the means of OCT (Optical coherence tomography) and OCTA.
Note: The trial was registered retrospectively on Clinicaltrials.gov after start of recruitment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Air group | Experimental | Procedure: AirAir tamponade after vitrectomy. |
| SF6 group | Experimental | Procedure: 10% SF6 and 90% air10% SF6 tamponade after vitrectomy. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient must be able and willing to give informed consent.
- Patient must be between 18 and 100 years of age.
- Patient must not have any significant media opacity which interferes with the examination.
- Patient must have an (stage 1-4) idiopathic macular hole requiring surgery.
Key exclusion criteria (17 listed)
- Unwilling or unable to provide informed consent
- Under 18 or over 100 years of age
- Significant media opacities
- Systemic pathologies making an examination difficult or cumbersome to the patient
- Primary and/or secondary epiretinal membranes (ERM), except incipient ERMs not affecting the foveal contour and not requiring surgery
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 |
|---|---|---|
| AirTest if air is sufficient for macular hole closure. | Procedure or surgery | Air group |
| 10% SF6 and 90% airTest if 10% SF6 and 90% air is sufficient for macular hole closure. | Procedure or surgery | SF6 group |
Primary outcome
Macular hole closure
Time frame: 2 weeks
2 secondary outcomes
Foveal avascular zone area
Time frame: 3 months
Parafoveal vessel density
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
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 Air and 10% SF6 and 90% air in people with Macular Holes and Optical Coherence Tomography, run by Medical University of Graz at 1 site in Austria.
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 17 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: finished, as of the sponsor's last update on 13 Sep 2023. 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 Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Macular hole closure (time frame: 2 weeks). 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 13 Sep 2023.