Macular HolesNCT04883697
Retrospective Evaluation of Risk Factors for Lower Outcomes After Vitrectomy With ILM Flap Technique
An observational study of Macular Holes, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
A retrospective review of medical charts of patients having undergone vitrectomy with ILM Peeling and ILM flap technique for macular hole repair. Read more about this study
- Who is it for?
- Ages 18 to 105 years
- Conditions the study is for
- Macular Holes
- What is being tested?
- vitrectomy with ILM peeling and ILM flap technique
- How many people
- 71 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jan 2021to 1 May 2021
- 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 to 105 years
- All sexes
- Adult, Older adult
Study population: all patieints have undergone vitrectomy with ILM peeling and ILM flap technique in the time period form 1.1.2015 to 31.4.2020 for macular hole repair
Who may be able to join
- Vitrectomy with ILM peeling and ILM flap technique in the time period form 1.1.2015 to 31.4.2020
- Age 18 or older
Who cannot join
- Age <18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Evaluation of Risk Factors for Lower Outcomes After Vitrectomy With ILM Flap
A retrospective review of medical charts of patients having undergone vitrectomy with ILM Peeling and ILM flap technique for macular hole repair.
Read the detailed description
A retrospective review of medical charts of patients having undergone vitrectomy with ILM Peeling and ILM flap technique for macular hole repair. Pre- and postoperative OCT and visual acuity in the time period up to 6 months after surgery are reviewed and possible risk factors for failed macular hole closure or lower visual acuity outcome after surgery are assessed.
- Conditions
- Macular Holes
- Being tested
- vitrectomy with ILM peeling and ILM flap technique
- Medical subject headings
- Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitrectomy with ILM peeling and ILM flap techniqueOther
outcomes after vitrectomy with ILM peeling and ILM flap technique for macukar hole repair are assessed
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity
best corrected distance visual acuity
Measured: change between visual acuity 2-6 months postoperative to baseline
macular hole closure
closure of the macular hole assesed with OCT
Measured: 2-6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start1 Jan 2021
- Primary completion1 May 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 71 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, Principal investigator, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883697
- Sponsor's protocol ID
- RAI
- Status last verified
- May 2021
- First submitted
- 1 May 2021
- Last updated
- 12 May 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 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of Risk Factors for Lower Outcomes After Vitrectomy With ILM Flap
- ClinicalTrials.gov ID
- NCT04883697
- Acronym / sponsor ID
- RAI
- Conditions
- Macular Holes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 12 May 2021 (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.
A retrospective review of medical charts of patients having undergone vitrectomy with ILM Peeling and ILM flap technique for macular hole repair.
Detailed description
A retrospective review of medical charts of patients having undergone vitrectomy with ILM Peeling and ILM flap technique for macular hole repair. Pre- and postoperative OCT and visual acuity in the time period up to 6 months after surgery are reviewed and possible risk factors for failed macular hole closure or lower visual acuity outcome after surgery are assessed.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- all patieints have undergone vitrectomy with ILM peeling and ILM flap technique in the time period form 1.1.2015 to 31.4.2020 for macular hole repair
Key inclusion criteria (2 listed)
- Vitrectomy with ILM peeling and ILM flap technique in the time period form 1.1.2015 to 31.4.2020
- Age 18 or older
Key exclusion criteria (1 listed)
- Age <18
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 |
|---|---|---|
| vitrectomy with ILM peeling and ILM flap techniqueoutcomes after vitrectomy with ILM peeling and ILM flap technique for macukar hole repair are assessed | Other | – |
Primary outcome
visual acuity
Time frame: change between visual acuity 2-6 months postoperative to baseline
best corrected distance visual acuity
macular hole closure
Time frame: 2-6 months postoperative
closure of the macular hole assesed with OCT
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 12 May 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 principal investigator
Vienna Institute for Research in Ocular Surgery
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 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 2 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 12 May 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?
visual acuity (time frame: change between visual acuity 2-6 months postoperative to baseline). 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 12 May 2021.