Epiretinal MembraneNCT03583632
Visual Acuity and Optical Coherence Tomography One Year After Peeling of Epiretinal Membranes
An observational study of Epiretinal Membrane, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
Improvement in visual acuity and retinal anatomy one year after surgery is assessed and compared to data preoperative and 3 months after surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epiretinal Membrane
- What is being tested?
- visual acuity testing and optical coherence tomography
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- 1 siteAustria
- Study dates
- 1 Feb 2018to 31 Dec 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: For this study only patients after vitrectomy with Membrane Peeling due to epiretinal membranes are selected
Who may be able to join
- vitrectomy with Membrane Peeling due to an epiretinal membrane
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Austria1 site
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
Vienna, 1140
About this study
Improvement in visual acuity and retinal anatomy one year after surgery is assessed and compared to data preoperative and 3 months after surgery
Read the detailed description
Improvement in visual acuity and retinal anatomy (documented by optical coherence tomography) one year after surgery is assessed and compared to data preoperative and 3 months after surgery. Improvements in retinal morphology are analysed by remission of optical coherence biomarkers after surgery. Aim of the study is to examine possible improvements of surgical outcomes in the period up to the one year follow-up.
- Conditions
- Epiretinal Membrane
- Being tested
- visual acuity testing, optical coherence tomography
- Medical subject headings
- Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visual acuity testingOther
testing of visual ycuity by ETDRS charts
optical coherence tomographyDevice
optical coherence tomography generates sectional slides of the retinal tomography with light
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity
visual acuity testing with EDTRS charts
Measured: 3 minutes
Secondary outcomes (1)
optical coherence tomography
optical coherence tomography generates slides of the retinal anatomy with light
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start1 Feb 2018
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epiretinal MembraneStudies 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
- Other
- Enrolment
- 75 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, MD, Prof, Principal investigator, VIROS at Hanuschkrankenhaus Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583632
- Sponsor's protocol ID
- ERM 1year follow-up
- Status last verified
- Mar 2024
- First submitted
- 28 Jun 2018
- Last updated
- 15 Mar 2024
- 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 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Acuity and Optical Coherence Tomography One Year After Peeling of Epiretinal Membranes
- ClinicalTrials.gov ID
- NCT03583632
- Acronym / sponsor ID
- ERM 1year follow-up
- Conditions
- Epiretinal Membrane
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 11 Jul 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.
Improvement in visual acuity and retinal anatomy one year after surgery is assessed and compared to data preoperative and 3 months after surgery
Detailed description
Improvement in visual acuity and retinal anatomy (documented by optical coherence tomography) one year after surgery is assessed and compared to data preoperative and 3 months after surgery. Improvements in retinal morphology are analysed by remission of optical coherence biomarkers after surgery. Aim of the study is to examine possible improvements of surgical outcomes in the period up to the one year follow-up.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- For this study only patients after vitrectomy with Membrane Peeling due to epiretinal membranes are selected
Key inclusion criteria (1 listed)
- vitrectomy with Membrane Peeling due to an epiretinal membrane
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 |
|---|---|---|
| visual acuity testingtesting of visual ycuity by ETDRS charts | Other | – |
| optical coherence tomographyoptical coherence tomography generates sectional slides of the retinal tomography with light | Device | – |
Primary outcome
visual acuity
Time frame: 3 minutes
visual acuity testing with EDTRS charts
1 secondary outcome
optical coherence tomography
Time frame: 3 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 15 Mar 2024.
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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, MD, 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 Epiretinal Membrane, 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 15 Mar 2024. 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: 3 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 15 Mar 2024.