Idiopathic Epiretinal MembranesNCT04997876
Diagnostic Reliability of OCT Biomarkers for iERM
An observational study of Idiopathic Epiretinal Membranes, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
Several optical coherence tomography (OCT) biomarkers with potential to influence postsurgical outcomes after vitrectomy with membrane peeling for idiopathic epiretinal membranes (iERM) have been described in single predictor analyses in the past. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Epiretinal Membranes
- What is being tested?
- Biomarker analysis
- How many people
- 136 participants
- Where
- 1 siteAustria
- Study dates
- 11 Jan 2021to 21 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with iERM sheduled for vitrectomy with membrane peeling.
Who may be able to join
- a) presence of an iERM,
- b) indication for membrane peeling, defined as significant loss of visual acuity and/or metamorphopsia due to the ERM,
- c) pseudophakia at the final visit at 3 months after surgery, and
- d) written informed consent for study participation.
Who cannot join
- macular edema caused by conditions other than ERM were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Reliability of OCT Biomarkers for Idiopathic Epiretinal Membranes
Several optical coherence tomography (OCT) biomarkers with potential to influence postsurgical outcomes after vitrectomy with membrane peeling for idiopathic epiretinal membranes (iERM) have been described in single predictor analyses in the past. Aim of the study is to assess the reliability of diagnosis of OCT biomarkers and to calculate their impact on postsurgical visual acuity in a multiple regression analysis.
Read the detailed description
Several optical coherence tomography (OCT) biomarkers with potential to influence postsurgical outcomes after vitrectomy with membrane peeling for idiopathic epiretinal membranes (iERM) have been described in single predictor analyses in the past. A recent multifactorial analysis outlined macular thickness and DRIL to be significant predictors for postsurgical visual acuity (Karasavviodou et al.). Nevertheless, reliability of diagnosing OCT biomarkes among patients with iERM was not yet assessed, to our knowledge. Aim of the study is to assess the reliability of diagnosis of OCT biomarkers and to calculate their impact on postsurgical visual acuity in a multiple regression analysis.
- Conditions
- Idiopathic Epiretinal Membranes
- Being tested
- Biomarker analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker analysisOther
Biomarkers from presurgical OCTs are assessed
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Biomarkers from presurgical OCTs are diagnosed Receives: Other: Biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
reliability of diagnosing OCT biomarkers
The presence (yes/no) of following OCT biomarkers are diagnosed from preoperative OCTs: EIFL, DRIL, intraretinal cystoid changes, alterations of the ellipsoid zone, cotton ball sign, HR-foci, EMM-rips, and retinal contraction. Intra- and interobserver reliability is assessed from 2 different readers, and reliability of OCT biomarkers will be calculated with the Kuder Richardson 20 test, due to the dichtomic nature of outcomes.
Measured: 1 week
Secondary outcomes (2)
postsurgical best corrected visual acuity
best corrected visual acuity 3 months after surgery is used for regression analysis
Measured: 3 months
central macular thickness
presurgical central subfield thickness of the macula is assessed by the software of the OCT device. The subfield thickness with a diameter of 1mm will be selected.
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 posted10 Aug 2021
- Study start11 Jan 2021
- Primary completion5 Aug 2021
- Study completion21 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Epiretinal MembranesStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 136 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 department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997876
- Sponsor's protocol ID
- biomarkers
- Status last verified
- Aug 2021
- First submitted
- 2 Aug 2021
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Karasavvidou EM, Panos GD, Koronis S, Kozobolis VP, Tranos PG. Optical coherence tomography biomarkers for visual acuity in patients with idiopathic epiretinal membrane. Eur J Ophthalmol. 2021 Nov;31(6):3203-3213. doi: 10.1177/1120672120980951. Epub 2020 Dec 14.
PubMed 33307784
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
- Diagnostic Reliability of OCT Biomarkers for Idiopathic Epiretinal Membranes
- ClinicalTrials.gov ID
- NCT04997876
- Acronym / sponsor ID
- biomarkers
- Conditions
- Idiopathic Epiretinal Membranes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 5 Aug 2021 (actual)
- Study completion
- 21 Aug 2021 (actual)
- First posted
- 10 Aug 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.
Several optical coherence tomography (OCT) biomarkers with potential to influence postsurgical outcomes after vitrectomy with membrane peeling for idiopathic epiretinal membranes (iERM) have been described in single predictor analyses in the past. Aim of the study is to assess the reliability of diagnosis of OCT biomarkers and to calculate their impact on postsurgical visual acuity in a multiple regression analysis.
Detailed description
Several optical coherence tomography (OCT) biomarkers with potential to influence postsurgical outcomes after vitrectomy with membrane peeling for idiopathic epiretinal membranes (iERM) have been described in single predictor analyses in the past. A recent multifactorial analysis outlined macular thickness and DRIL to be significant predictors for postsurgical visual acuity (Karasavviodou et al.). Nevertheless, reliability of diagnosing OCT biomarkes among patients with iERM was not yet assessed, to our knowledge. Aim of the study is to assess the reliability of diagnosis of OCT biomarkers and to calculate their impact on postsurgical visual acuity in a multiple regression analysis.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: Biomarker analysisBiomarkers from presurgical OCTs are diagnosed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with iERM sheduled for vitrectomy with membrane peeling.
Key inclusion criteria (4 listed)
- a) presence of an iERM,
- b) indication for membrane peeling, defined as significant loss of visual acuity and/or metamorphopsia due to the ERM,
- c) pseudophakia at the final visit at 3 months after surgery, and
- d) written informed consent for study participation.
Key exclusion criteria (1 listed)
- macular edema caused by conditions other than ERM were excluded from the study.
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 |
|---|---|---|
| Biomarker analysisBiomarkers from presurgical OCTs are assessed | Other | Study Group |
Primary outcome
reliability of diagnosing OCT biomarkers
Time frame: 1 week
The presence (yes/no) of following OCT biomarkers are diagnosed from preoperative OCTs: EIFL, DRIL, intraretinal cystoid changes, alterations of the ellipsoid zone, cotton ball sign, HR-foci, EMM-rips, and retinal contraction. Intra- and interobserver reliability is assessed from 2 different readers, and reliability of OCT biomarkers will be calculated with the Kuder Richardson 20 test, due to the dichtomic nature of outcomes.
2 secondary outcomes
postsurgical best corrected visual acuity
Time frame: 3 months
central macular thickness
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 24 Aug 2021.
- Background: PubMed 33307784Karasavvidou EM, Panos GD, Koronis S, Kozobolis VP, Tranos PG. Optical coherence tomography biomarkers for visual acuity in patients with idiopathic epiretinal membrane. Eur J Ophthalmol. 2021 Nov;31(6):3203-3213. doi: 10.1177/1120672120980951. Epub 2020 Dec 14.
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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
head of department
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 Idiopathic Epiretinal Membranes, 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 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?
reliability of diagnosing OCT biomarkers (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04997876, which also lists 1 linked publication.
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.