Intraoperative Analysis of the Central Retina in ERF

March 15, 2021 updated by: Lyskin Pavel Vladimirovich, MD, PhD, The S.N. Fyodorov Eye Microsurgery State Institution

Intraoperative Analysis of the Central Retina in Epiretinal Fibrosis

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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 82 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BCVA < 0,6;

Exclusion Criteria:.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 15, 2019

Primary Completion (ANTICIPATED)

January 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

December 6, 2020

First Submitted That Met QC Criteria

March 15, 2021

First Posted (ACTUAL)

March 17, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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