Diagnostic Reliability of OCT Biomarkers for iERM

Vienna Institute for Research in Ocular Surgery136 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

136

Conditions

Idiopathic Epiretinal Membranes

Interventions

Biomarker analysisOTHER

Biomarkers from presurgical OCTs are assessed

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

VIROS at Hanusch-Hospital Vienna

Vienna, Austria

Outcomes

Primary Outcomes

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.

Time frame: 1 week

Secondary Outcomes

postsurgical best corrected visual acuity

best corrected visual acuity 3 months after surgery is used for regression analysis

Time frame: 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.

Time frame: 5 minutes

Data from ClinicalTrials.gov

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