NCT04802915

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2019

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 17, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

3 years

First QC Date

December 6, 2020

Last Update Submit

March 15, 2021

Conditions

Epiretinal MembraneMacular Pucker

Keywords

epiretinal membraneinternal limiting membraneepiretinal fibrosismacular puckercentral retina

Outcome Measures

Primary Outcomes (4)

  • ILM integrity

    Visual intraoperative assessment of the ILM integrity

    intraoperative

  • Length and localization of the ILM dialysis

    Length (in degrees) and localization of the ILM dyalisis

    intraoperative

  • ILM displacement

    ILM displacement direction during the formation of detachment and divulsion.

    intraoperative

  • Occurence of ILM dyalisis

    Determination of the ratio of patients with ILM dialysis to the total number of patients with ERF

    intraoperative

Study Arms (1)

epiretinal membrane group

OTHER

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

Interventions

Intraoperative ERM and ILM staining with their assessment and removalPROCEDURE

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

epiretinal membrane group

Eligibility Criteria

Age50 Years - 82 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BCVA \< 0,6;

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Moscow, 127486, Russia

RECRUITING

MeSH Terms

Conditions

Epiretinal Membrane

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Pavel V Lyskin, PhD

    The S.N. Fyodorov Eye Microsurgery State Institution

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pavel V Lyskin, PhD

CONTACT

+74994888926plyskin@yahoo.com

Irina R Makarenko, MD

CONTACT

+79032101254makarenkoirina505@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, ophthalmosurgeon

Study Record Dates

First Submitted

December 6, 2020

First Posted

March 17, 2021

Study Start

January 15, 2019

Primary Completion

January 1, 2022

Study Completion

December 1, 2022

Last Updated

March 17, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)