Diagnostic Reliability of OCT Biomarkers for iERM

Idiopathic Epiretinal Membranes Clinical Trial

Official title:

Diagnostic Reliability of OCT Biomarkers for Idiopathic Epiretinal Membranes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04997876
• Other study ID #: biomarkers
• Status: Completed
• Start date: January 11, 2021
• Est. completion date: August 21, 2021

Study information

• Verified date: August 2021
• Source: Vienna Institute for Research in Ocular Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: August 21, 2021
• Est. primary completion date: August 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Epiretinal Membrane
• Idiopathic Epiretinal Membranes

Intervention

Other:
• Biomarker analysis
Biomarkers from presurgical OCTs are assessed

Locations

Country	Name	City	State
Austria	VIROS at Hanusch-Hospital Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Vienna Institute for Research in Ocular Surgery

Country where clinical trial is conducted

Austria, 

References & Publications (1)

Karasavvidou EM, Panos GD, Koronis S, Kozobolis VP, Tranos PG. Optical coherence tomography biomarkers for visual acuity in patients with idiopathic epiretinal membrane. Eur J Ophthalmol. 2020 Dec 14:1120672120980951. doi: 10.1177/1120672120980951. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	postsurgical best corrected visual acuity	best corrected visual acuity 3 months after surgery is used for regression analysis	3 months
Secondary	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