Intraoperative Analysis of the Central Retina in ERF

NCT ID: NCT04802915

Last Updated: 2021-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-15

Study Completion Date

2022-12-31

Brief Summary

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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

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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

Conditions

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Epiretinal Membrane Macular Pucker

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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epiretinal membrane group

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

Group Type OTHER

Intraoperative ERM and ILM staining with their assessment and removal

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* BCVA \< 0,6;

Exclusion Criteria

* secondary ERM, glaucoma, diabetic retinopathy, high myopia, BCVA\>0,6
Minimum Eligible Age

50 Years

Maximum Eligible Age

82 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Makarenko Irina Romanovna

UNKNOWN

Sponsor Role collaborator

Zgoba Mariana Igorevna

UNKNOWN

Sponsor Role collaborator

The S.N. Fyodorov Eye Microsurgery State Institution

OTHER_GOV

Sponsor Role lead

Responsible Party

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Lyskin Pavel Vladimirovich, MD, PhD

MD, PhD, ophthalmosurgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pavel V Lyskin, PhD

Role: PRINCIPAL_INVESTIGATOR

The S.N. Fyodorov Eye Microsurgery State Institution

Locations

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S.N. Fedorov Nmrc "Mntk "Eye Microsurgery"

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Pavel V Lyskin, PhD

Role: CONTACT

+74994888926

Irina R Makarenko, MD

Role: CONTACT

+79032101254

Facility Contacts

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Pavel V Lyskin, PhD

Role: primary

+74994888926

Irina R Makarenko, MD

Role: backup

+79032101254

Other Identifiers

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124575

Identifier Type: -

Identifier Source: org_study_id

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