Intraoperative Analysis of the Central Retina in ERF

Not Applicable

• Conditions: Epiretinal Membrane; Macular Pucker
• Interventions: Procedure: Intraoperative ERM and ILM staining with their assessment and removal

• Registration Number: NCT04802915
• Lead Sponsor: The S.N. Fyodorov Eye Microsurgery State Institution

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2019-01-15
• Study First Submitted: 2020-12-06
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-15
• Last Update Submitted: 2021-03-15
• Study First Posted: 2021-03-17
• Last Update Posted: 2021-03-17
• Primary Completion: 2022-01
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• BCVA < 0,6;

Exclusion Criteria

.

• secondary ERM, glaucoma, diabetic retinopathy, high myopia, BCVA>0,6

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
epiretinal membrane group	Intraoperative ERM and ILM staining with their assessment and removal	Patient with epiretinal fibrosis confirmed by OCT with BCVA\< 0,6 and complaints of metamorphopsies

Primary Outcome Measures

Name	Time	Method
ILM integrity	intraoperative	Visual intraoperative assessment of the ILM integrity
ILM displacement	intraoperative	ILM displacement direction during the formation of detachment and divulsion.
Length and localization of the ILM dialysis	intraoperative	Length (in degrees) and localization of the ILM dyalisis
Occurence of ILM dyalisis	intraoperative	Determination of the ratio of patients with ILM dialysis to the total number of patients with ERF

Trial Locations

Locations (1)

S.N. Fedorov Nmrc "Mntk "Eye Microsurgery"; 🇷🇺 Moscow, Russian Federation