Diagnostic Reliability of OCT Biomarkers for iERM

Study Overview
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Brief Summary
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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
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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.

Official Title
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Diagnostic Reliability of OCT Biomarkers for Idiopathic Epiretinal Membranes

Conditions
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Idiopathic Epiretinal Membranes

Intervention / Treatment
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* Other: Biomarker analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: macular edema caused by conditions other than ERM were excluded from the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Group<br>Biomarkers from presurgical OCTs are diagnosed | Other: Biomarker analysis<br>* Biomarkers from presurgical OCTs are assessed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postsurgical best corrected visual acuity | best corrected visual acuity 3 months after surgery is used for regression analysis | 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. | 5 minutes |