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Completed

NCT Number: NCT04997876

Diagnostic Reliability of OCT Biomarkers for iERM

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.

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Key information

Conditions

Idiopathic Epiretinal Membranes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

VIROS at Hanusch-Hospital Vienna

Vienna, 1140, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biomarker Analysis

Other

Biomarkers from presurgical OCTs are assessed

Primary outcomes

  1. 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.

Secondary outcomes

  1. postsurgical best corrected visual acuity

    Time frame: 3 months

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

  2. central macular thickness

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vienna Institute for Research in Ocular Surgery

Other

Registry information

Official study title

Diagnostic Reliability of OCT Biomarkers for Idiopathic Epiretinal Membranes

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 10, 2021
Registry last updated
Aug 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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