Diagnostic Reliability of OCT Biomarkers for iERM

Completed

• Conditions: Idiopathic Epiretinal Membranes
• Interventions: Other: Biomarker analysis

• Registration Number: NCT04997876
• Lead Sponsor: Vienna Institute for Research in Ocular Surgery

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.

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 Timeline

• Study Start: 2021-01-11
• Status Verified: 2021-08
• Study First Submitted: 2021-08-02
• Primary Completion: 2021-08-05
• Study First Submitted QC: 2021-08-09
• Study First Posted: 2021-08-10
• Study Completion: 2021-08-21
• Last Update Submitted: 2021-08-21
• Last Update Posted: 2021-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Group	Biomarker analysis	Biomarkers from presurgical OCTs are diagnosed

Primary Outcome Measures

Name	Time	Method
reliability of diagnosing OCT biomarkers	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.

Secondary Outcome Measures

Name	Time	Method
postsurgical best corrected visual acuity	3 months	best corrected visual acuity 3 months after surgery is used for regression analysis
central macular thickness	5 minutes	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.

Trial Locations

Locations (1)

VIROS at Hanusch-Hospital Vienna; 🇦🇹 Vienna, Austria