Back to resultsIntraoperative Analysis of the Central Retina in ERF
Primary Purpose
Epiretinal Membrane, Macular Pucker
Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Intraoperative ERM and ILM staining with their assessment and removal
Sponsored by
About this trial
This is an interventional treatment trial for Epiretinal Membrane focused on measuring epiretinal membrane, internal limiting membrane, epiretinal fibrosis, macular pucker, central retina
Eligibility Criteria
Inclusion Criteria:
- BCVA < 0,6;
Exclusion Criteria:.
- secondary ERM, glaucoma, diabetic retinopathy, high myopia, BCVA>0,6
Sites / Locations
- S.N. Fedorov Nmrc "Mntk "Eye Microsurgery"Recruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
epiretinal membrane group
Arm Description
Patient with epiretinal fibrosis confirmed by OCT with BCVA< 0,6 and complaints of metamorphopsies
Outcomes
Primary Outcome Measures
ILM integrity
Visual intraoperative assessment of the ILM integrity
Length and localization of the ILM dialysis
Length (in degrees) and localization of the ILM dyalisis
ILM displacement
ILM displacement direction during the formation of detachment and divulsion.
Occurence of ILM dyalisis
Determination of the ratio of patients with ILM dialysis to the total number of patients with ERF
Secondary Outcome Measures
Full Information
NCT ID
NCT04802915
First Posted
December 6, 2020
Last Updated
March 15, 2021
Sponsor
The S.N. Fyodorov Eye Microsurgery State Institution
Collaborators
Makarenko Irina Romanovna, Zgoba Mariana Igorevna
1. Study Identification
Unique Protocol Identification Number
NCT04802915
Brief Title
Intraoperative Analysis of the Central Retina in ERF
Official Title
Intraoperative Analysis of the Central Retina in Epiretinal Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The S.N. Fyodorov Eye Microsurgery State Institution
Collaborators
Makarenko Irina Romanovna, Zgoba Mariana Igorevna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiretinal Membrane, Macular Pucker
Keywords
epiretinal membrane, internal limiting membrane, epiretinal fibrosis, macular pucker, central retina
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
epiretinal membrane group
Arm Type
Other
Arm Description
Patient with epiretinal fibrosis confirmed by OCT with BCVA< 0,6 and complaints of metamorphopsies
Intervention Type
Procedure
Intervention Name(s)
Intraoperative ERM and ILM staining with their assessment and removal
Intervention Description
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
Primary Outcome Measure Information:
Title
ILM integrity
Description
Visual intraoperative assessment of the ILM integrity
Time Frame
intraoperative
Title
Length and localization of the ILM dialysis
Description
Length (in degrees) and localization of the ILM dyalisis
Time Frame
intraoperative
Title
ILM displacement
Description
ILM displacement direction during the formation of detachment and divulsion.
Time Frame
intraoperative
Title
Occurence of ILM dyalisis
Description
Determination of the ratio of patients with ILM dialysis to the total number of patients with ERF
Time Frame
intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
82 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BCVA < 0,6;
Exclusion Criteria:.
secondary ERM, glaucoma, diabetic retinopathy, high myopia, BCVA>0,6
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pavel V Lyskin, PhD
Phone
+74994888926
Email
plyskin@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Irina R Makarenko, MD
Phone
+79032101254
Email
makarenkoirina505@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pavel V Lyskin, PhD
Organizational Affiliation
The S.N. Fyodorov Eye Microsurgery State Institution
Official's Role
Principal Investigator
Facility Information:
Facility Name
S.N. Fedorov Nmrc "Mntk "Eye Microsurgery"
City
Moscow
ZIP/Postal Code
127486
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pavel V Lyskin, PhD
Phone
+74994888926
Email
plyskin@yahoo.com
First Name & Middle Initial & Last Name & Degree
Irina R Makarenko, MD
Phone
+79032101254
Email
makarenkoirina505@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intraoperative Analysis of the Central Retina in ERF
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