Macular HolesNCT03646695
ILM Flap Transposition Versus ILM Peeling for Macular Holes: a Pilot Study
A study testing ILM flap transposition and ILM peeling in people with Macular Holes, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
Patients with macular hole <400µm will be randomized for ILM flap Transposition and ILM Peeling for surgical repair of macular holes Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Holes
- What is being tested?
- ILM flap transposition and ILM peeling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- 1 Sep 2018to 1 May 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- macular hole with a diameter <400µm
Who cannot join
- Prior ILM peeling
Trial locations and contacts
1 site in 1 country.
Austria1 site
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital
Vienna, 1140
About this study
Patients with macular hole <400µm will be randomized for ILM flap Transposition and ILM Peeling for surgical repair of macular holes
Read the detailed description
Patients with macular hole with a diameter larger than 400µm have better sucess with ILM flap transposition, but there are no data published examining the outcome of macular hole with a diameter <400µm. Therefore, patients with macular hole with a diameter <400µm will be randomized for ILM flap transposition and ILM peeling for surgical repair of macular holes
- Conditions
- Macular Holes
- Being tested
- ILM flap transposition, ILM peeling
- Medical subject headings
- Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ILM flap transpositionProcedure or surgery
during ILM flap Transposition, an ILM flap is placed on the macular hole
ILM peelingProcedure or surgery
during ILM Peeling the ILM is removed around the macular hole
| Study group | Role | What they receive |
|---|---|---|
| ILM flap | Experimental | vitrectomy with ILM flap transposition and gas-tamponade will be performed Receives: Procedure: ILM flap transposition |
| ILM peeling | Active comparator | vitrectomy with ILM peeling and gas-tamponade will be performed Receives: Procedure: ILM peeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
closure of the macular hole
closure of the macular hole will be assessed
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 posted24 Aug 2018
- Study start1 Sep 2018
- Primary completion1 Jan 2021
- Study completion1 May 2021
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.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vienna Institute for Research in Ocular Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
- Investigators
- Oliver Findl, Professor, Principal investigator, Head of Department of Ophthalmology, Professor, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646695
- Sponsor's protocol ID
- ILM flap
- Status last verified
- Aug 2021
- First submitted
- 23 Aug 2018
- Last updated
- 24 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ILM Flap Transposition Versus ILM Peeling for Macular Holes: a Pilot Study
- ClinicalTrials.gov ID
- NCT03646695
- Acronym / sponsor ID
- ILM flap
- Conditions
- Macular Holes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 24 Aug 2018 (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.
Patients with macular hole <400µm will be randomized for ILM flap Transposition and ILM Peeling for surgical repair of macular holes
Detailed description
Patients with macular hole with a diameter larger than 400µm have better sucess with ILM flap transposition, but there are no data published examining the outcome of macular hole with a diameter <400µm. Therefore, patients with macular hole with a diameter <400µm will be randomized for ILM flap transposition and ILM peeling for surgical repair of macular holes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ILM flap | Experimental | Procedure: ILM flap transpositionvitrectomy with ILM flap transposition and gas-tamponade will be performed |
| ILM peeling | Active comparator | Procedure: ILM peelingvitrectomy with ILM peeling and gas-tamponade will be performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- macular hole with a diameter <400µm
Key exclusion criteria (1 listed)
- Prior ILM peeling
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 |
|---|---|---|
| ILM flap transpositionduring ILM flap Transposition, an ILM flap is placed on the macular hole | Procedure or surgery | ILM flap |
| ILM peelingduring ILM Peeling the ILM is removed around the macular hole | Procedure or surgery | ILM peeling |
Primary outcome
closure of the macular hole
Time frame: 3 months
closure of the macular hole will be assessed
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 24 Aug 2021.
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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.
Oliver Findl, Professor principal investigator
Head of Department of Ophthalmology, Professor, Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ILM flap transposition and ILM peeling in people with Macular Holes, run by Vienna Institute for Research in Ocular Surgery 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 1 inclusion and 1 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 24 Aug 2021. 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?
closure of the macular hole (time frame: 3 months). 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 24 Aug 2021.