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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04802915
Other study ID # 124575
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 15, 2019
Est. completion date December 2022

Study information

Verified date March 2021
Source The S.N. Fyodorov Eye Microsurgery State Institution
Contact Pavel V Lyskin, PhD
Phone +74994888926
Email plyskin@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Changes in the retinal anatomy that occur in epiretinal fibrosis have not been sufficiently studied. It is possible that epiretinal fibrosis leads not only to traction dislocation of the macula, but also to ILM anatomical disorders.


Description:

Purpose: to study anatomical changes in the Central retina in epiretinal fibrosis. Surgical treatment: standard vitrectomy 25-27G; ERM amd ILM stainig by Membrane Blue Dual; epiretinal membrane removal, ILM peeling if the divulsion of ILM was detected. Expected results: improving the quality of epiretinal fibrosis surgery by obtaining a more detailed picture of the pathological process


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 2022
Est. primary completion date January 2022
Accepts healthy volunteers No
Gender All
Age group 50 Years to 82 Years
Eligibility Inclusion Criteria: - BCVA < 0,6; Exclusion Criteria:. - secondary ERM, glaucoma, diabetic retinopathy, high myopia, BCVA>0,6

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Intraoperative ERM and ILM staining with their assessment and removal
ERM and ILM staining is performed after vitrectomy. After that we evaluate the condition of macular zone and make a decision to remove the ERM and the need to remove the ILM

Locations

Country Name City State
Russian Federation S.N. Fedorov Nmrc "Mntk "Eye Microsurgery" Moscow

Sponsors (3)

Lead Sponsor Collaborator
The S.N. Fyodorov Eye Microsurgery State Institution Makarenko Irina Romanovna, Zgoba Mariana Igorevna

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary ILM integrity Visual intraoperative assessment of the ILM integrity intraoperative
Primary Length and localization of the ILM dialysis Length (in degrees) and localization of the ILM dyalisis intraoperative
Primary ILM displacement ILM displacement direction during the formation of detachment and divulsion. intraoperative
Primary Occurence of ILM dyalisis Determination of the ratio of patients with ILM dialysis to the total number of patients with ERF intraoperative
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