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Diagnostic Reliability of OCT Biomarkers for iERM

Diagnostic Reliability of OCT Biomarkers for Idiopathic Epiretinal Membranes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04997876
Enrollment
136
Registered
2021-08-10
Start date
2021-01-11
Completion date
2021-08-21
Last updated
2021-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Epiretinal Membranes

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.

Interventions

Biomarkers from presurgical OCTs are assessed

Sponsors

Vienna Institute for Research in Ocular Surgery
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
reliability of diagnosing OCT biomarkers1 weekThe 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

MeasureTime frameDescription
postsurgical best corrected visual acuity3 monthsbest corrected visual acuity 3 months after surgery is used for regression analysis
central macular thickness5 minutespresurgical 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.

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026