Diagnostic Reliability of OCT Biomarkers for iERM
1 other identifier
observational
136
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 11, 2021
CompletedFirst Submitted
Initial submission to the registry
August 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 5, 2021
CompletedFirst Posted
Study publicly available on registry
August 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 21, 2021
CompletedAugust 24, 2021
August 1, 2021
7 months
August 2, 2021
August 21, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
1 week
Secondary Outcomes (2)
postsurgical best corrected visual acuity
3 months
central macular thickness
5 minutes
Study Arms (1)
Study Group
Biomarkers from presurgical OCTs are diagnosed
Interventions
Eligibility Criteria
Patients with iERM sheduled for vitrectomy with membrane peeling.
You may qualify if:
- 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.
You may not qualify if:
- macular edema caused by conditions other than ERM were excluded from the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VIROS at Hanusch-Hospital Vienna
Vienna, 1140, Austria
Related Publications (1)
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.
PMID: 33307784BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Oliver Findl, Prof.
head of department
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof., MD, MBA
Study Record Dates
First Submitted
August 2, 2021
First Posted
August 10, 2021
Study Start
January 11, 2021
Primary Completion
August 5, 2021
Study Completion
August 21, 2021
Last Updated
August 24, 2021
Record last verified: 2021-08