Full Thickness Macular HoleNCT05897671
Foveal Sparing ILM Peeling With ILM Flap Transposition
An observational study of Full Thickness Macular Hole, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
Foveal sparing internal limiting membrane (ILM) peeling with ILM flap transposition over the macular hole combines the benefits of foveal sparing ILM peeling with ILM flap techniques. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Full Thickness Macular Hole
- What is being tested?
- retrospective data analysis
- How many people
- 42 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jun 2023to 1 Jun 2023
- 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
- Adult, Older adult
Study population: The participants will be selected by the clinical investigators in the Hanusch Hospital
Who may be able to join
- Vitrectomy with foveal sparing ILM peeling with ILM flap transposition in the time period from 1.10.2020 to 8.7.2022
- Age 18 and older
- Idiopathic full thickness macular hole as indication for surgery
- Full follow-up, including visual acuity testing and OCT preoperative, and 3 months after surgery.
Who cannot join
- Age <18 years
Trial locations and contacts
1 site in 1 country.
About this study
Foveal sparing internal limiting membrane (ILM) peeling with ILM flap transposition over the macular hole combines the benefits of foveal sparing ILM peeling with ILM flap techniques.
Aim of this study is to retrospectively examine the rate of postsurgical macular hole closure, development of central atrophy in the foveal area, and improvement of best corrected distant visual acuity in a group of patients having undergone foveal sparing ILM peeling with ILM flap transposition for macular hole repair.
Read the detailed description
Idiopathic full thickness macular holes lead to central defects in the visual field and to deterioration of the visual acuity. Introduction of internal limiting membrane (ILM) Peeling techniques lead to significant increase in closure rates of the macular holes.
Foveal sparing ILM peeling represents a surgical technique for macular hole repair with less surgical trauma with high closure rates of the macular hole, compared to classic ILM Peeling [Ho et al. 2014, Murphy et al 2019]. The combination of foveal sparing ILM Peeling with the established ILM flap techniques [Michalewska et al 2010 und 2015] offers the potential of better improvement in postsurgical visual acuity with the high closure rates, due to ILM flaps.
Aim of this study is to retrospectively examine the rate of postsurgical macular hole closure, development of central atrophy in the foveal area, and improvement of best corrected distant visual acuity in a group of patients having undergone foveal sparing ILM peeling with ILM flap transposition for macular hole repair.
- Conditions
- Full Thickness Macular Hole
- Being tested
- retrospective data analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrospective data analysisOther
Macular hole closure rate, visual acuity and OCT
| Study group | Role | What they receive |
|---|---|---|
| study group | retrospective data analysis of patients that underwent after foveal sparing ILM peeling with ILM flap transposition for macular hole repair Receives: Other: retrospective data analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
macular hole closure rate
postsurgical closure of macular holes is examined from routine postsurgical optical coherence tomography (OCT) imaging
Measured: up to 3 months after surgery
Secondary outcomes (2)
visual acuity
visual acuity before and 3 months after surgery is examined
Measured: 3 months
OCT
measurements of macular hole diameters from presurgical OCTs and restoration of the ellipsoid zone (EZ) 3 months after surgery is analysed
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 posted9 Jun 2023
- Study start1 Jun 2023
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Full Thickness 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 42 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, head of departement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897671
- Sponsor's protocol ID
- FSI
- Status last verified
- Jun 2023
- First submitted
- 1 Jun 2023
- Last updated
- 13 Jun 2023
- Results posted
- No
- 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 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foveal Sparing ILM Peeling With ILM Flap Transposition
- ClinicalTrials.gov ID
- NCT05897671
- Acronym / sponsor ID
- FSI
- Conditions
- Full Thickness Macular Hole
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 9 Jun 2023 (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.
Foveal sparing internal limiting membrane (ILM) peeling with ILM flap transposition over the macular hole combines the benefits of foveal sparing ILM peeling with ILM flap techniques.
Aim of this study is to retrospectively examine the rate of postsurgical macular hole closure, development of central atrophy in the foveal area, and improvement of best corrected distant visual acuity in a group of patients having undergone foveal sparing ILM peeling with ILM flap transposition for macular hole repair.
Detailed description
Idiopathic full thickness macular holes lead to central defects in the visual field and to deterioration of the visual acuity. Introduction of internal limiting membrane (ILM) Peeling techniques lead to significant increase in closure rates of the macular holes.
Foveal sparing ILM peeling represents a surgical technique for macular hole repair with less surgical trauma with high closure rates of the macular hole, compared to classic ILM Peeling [Ho et al. 2014, Murphy et al 2019]. The combination of foveal sparing ILM Peeling with the established ILM flap techniques [Michalewska et al 2010 und 2015] offers the potential of better improvement in postsurgical visual acuity with the high closure rates, due to ILM flaps.
Aim of this study is to retrospectively examine the rate of postsurgical macular hole closure, development of central atrophy in the foveal area, and improvement of best corrected distant visual acuity in a group of patients having undergone foveal sparing ILM peeling with ILM flap transposition for macular hole repair.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Other: retrospective data analysisretrospective data analysis of patients that underwent after foveal sparing ILM peeling with ILM flap transposition for macular hole repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The participants will be selected by the clinical investigators in the Hanusch Hospital
Key inclusion criteria (4 listed)
- Vitrectomy with foveal sparing ILM peeling with ILM flap transposition in the time period from 1.10.2020 to 8.7.2022
- Age 18 and older
- Idiopathic full thickness macular hole as indication for surgery
- Full follow-up, including visual acuity testing and OCT preoperative, and 3 months after surgery.
Key exclusion criteria (1 listed)
- Age <18 years
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 |
|---|---|---|
| retrospective data analysisMacular hole closure rate, visual acuity and OCT | Other | study group |
Primary outcome
macular hole closure rate
Time frame: up to 3 months after surgery
postsurgical closure of macular holes is examined from routine postsurgical optical coherence tomography (OCT) imaging
2 secondary outcomes
visual acuity
Time frame: 3 months
OCT
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 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Full Thickness Macular Hole
Active, not recruiting
Outcomes of Macular Hole Surgery With Inverted Flap With vs Without Post op Posturing With SF6 in Macular Hole More Than 400 Micrometres
Macular Hole
Recruiting
Full-Thickness Macular Hole Surgery: A Comparison of Ten Techniques
Macular Holes
Enrolling by invitation
Intraocular Gas Tamponade for Treatment of Large Idiopathic Macular Holes
Idiopathic Macular Hole, Macular Hole
Active, not recruitingObservational study
Subjective Pain Scoring for Subtenonal Anesthesia During Vitrectomy
Epiretinal Membranes, Retinal Detachment
Recruiting
Duration of Face Down Positioning for Full-Thickness Macular Hole Repair
Macular Holes
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
head of departement
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 Full Thickness 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 4 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 Jun 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 rate (time frame: up to 3 months after surgery). 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 Jun 2023.