Intraoperative Analysis of the Central Retina in ERF

Sponsor

The S.N. Fyodorov Eye Microsurgery State Institution (Other)

Overall Status

Recruiting

CT.gov ID

NCT04802915

Collaborator

Makarenko Irina Romanovna (Other), Zgoba Mariana Igorevna (Other)

Enrollment

Location

Arm

46.5

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epiretinal Membrane Macular Pucker	Procedure: Intraoperative ERM and ILM staining with their assessment and removal	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Intraoperative Analysis of the Central Retina in Epiretinal Fibrosis

Actual Study Start Date :

Jan 15, 2019

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: epiretinal membrane group Patient with epiretinal fibrosis confirmed by OCT with BCVA< 0,6 and complaints of metamorphopsies	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

Arm

Intervention/Treatment

Other: epiretinal membrane group

Patient with epiretinal fibrosis confirmed by OCT with BCVA< 0,6 and complaints of metamorphopsies

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 82 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

BCVA < 0,6;

Exclusion Criteria:.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	S.N. Fedorov Nmrc "Mntk "Eye Microsurgery"	Moscow		Russian Federation	127486

Sponsors and Collaborators

The S.N. Fyodorov Eye Microsurgery State Institution
Makarenko Irina Romanovna
Zgoba Mariana Igorevna

Investigators

Principal Investigator: Pavel V Lyskin, PhD, The S.N. Fyodorov Eye Microsurgery State Institution

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lyskin Pavel Vladimirovich, MD, PhD, MD, PhD, ophthalmosurgeon, The S.N. Fyodorov Eye Microsurgery State Institution

ClinicalTrials.gov Identifier:

NCT04802915

Other Study ID Numbers:

124575

First Posted:

Mar 17, 2021

Last Update Posted:

Mar 17, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Lyskin Pavel Vladimirovich, MD, PhD, MD, PhD, ophthalmosurgeon, The S.N. Fyodorov Eye Microsurgery State Institution

epiretinal membrane

internal limiting membrane

epiretinal fibrosis

macular pucker

central retina

Additional relevant MeSH terms:

Epiretinal Membrane

Study Results

No Results Posted as of Mar 17, 2021