Macular HoleNCT03465865
Visual Acuity and Optical Coherence Tomography One Year After ILM-flap Transposition
An observational study of Macular Hole, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
ILM-flap (internal limiting Membrane-flap) transposition is a new surgical option in repair of macular holes, therefore one year outcomes are needed to better evaluate that method. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Hole
- What is being tested?
- optical coherence tomography
- Type of treatment
- Medical device
- How many people
- 41 participants
- Where
- 1 siteAustria
- Study dates
- 1 Sep 2017to 31 Dec 2024
- Phase
- Observational
- 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
Study population: Patients are invited for a follow-up one year after ILM-flap transposition for surgical repair of macular holes
Who may be able to join
- history of ILM-flap transposition
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Austria1 site
VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital
Vienna, 1140
About this study
Official title: Visual Acuity and Optical Coherence Tomography One Year After ILM-flap Transposition for Surgical Repair of Macular Holes
ILM-flap (internal limiting Membrane-flap) transposition is a new surgical option in repair of macular holes, therefore one year outcomes are needed to better evaluate that method.
Read the detailed description
Patients that have been scheduled for vitrectomy with ILM-flap transposition, a new surgical option in repair of macular holes, are invited to a follow-up one year after surgery, including optical coherence tomography and visual acuity testing.
- Conditions
- Macular Hole
- Being tested
- optical coherence tomography
- Medical subject headings
- Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optical coherence tomographyDevice
Also called visual acuity test
optical coherence tomography enables diagosis of macular structures and therefore provides information on macular hole closure.
| Study group | Role | What they receive |
|---|---|---|
| ILM-flap | Patients after surgical repair of macular holes with ILM-flap transposition are invitied to a follow-up for optical coherence tomography and visual acuity testing one year after surgery Receives: Device: optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
OCT
macular hole closure is assessed with optical coherence tomography
Measured: 5 minutes
Secondary outcomes (1)
visual acuity
visual acuity describes functional outcomes of the eye
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start1 Sep 2017
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 41 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, Prof, Principal investigator, VIROS at Hanuschkrankenhaus Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465865
- Sponsor's protocol ID
- ILMflap
- Status last verified
- Feb 2025
- First submitted
- 8 Mar 2018
- Last updated
- 13 Feb 2025
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Acuity and Optical Coherence Tomography One Year After ILM-flap Transposition for Surgical Repair of Macular Holes
- ClinicalTrials.gov ID
- NCT03465865
- Acronym / sponsor ID
- ILMflap
- Conditions
- Macular Hole
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 14 Mar 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.
ILM-flap (internal limiting Membrane-flap) transposition is a new surgical option in repair of macular holes, therefore one year outcomes are needed to better evaluate that method.
Detailed description
Patients that have been scheduled for vitrectomy with ILM-flap transposition, a new surgical option in repair of macular holes, are invited to a follow-up one year after surgery, including optical coherence tomography and visual acuity testing.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ILM-flap | – | Device: optical coherence tomographyPatients after surgical repair of macular holes with ILM-flap transposition are invitied to a follow-up for optical coherence tomography and visual acuity testing one year after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are invited for a follow-up one year after ILM-flap transposition for surgical repair of macular holes
Key inclusion criteria (1 listed)
- history of ILM-flap transposition
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| optical coherence tomographyAlso: visual acuity testoptical coherence tomography enables diagosis of macular structures and therefore provides information on macular hole closure. | Device | ILM-flap |
Primary outcome
OCT
Time frame: 5 minutes
macular hole closure is assessed with optical coherence tomography
1 secondary outcome
visual acuity
Time frame: 5 minutes
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 Feb 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. This study is not recruiting at the moment.
Oliver Findl, Prof principal investigator
VIROS at Hanuschkrankenhaus Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Hole, 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 13 Feb 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 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?
OCT (time frame: 5 minutes). 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 Feb 2025.