- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04802915
Intraoperative Analysis of the Central Retina in ERF
Intraoperative Analysis of the Central Retina in Epiretinal Fibrosis
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pavel V Lyskin, PhD
- Phone Number: +74994888926
- Email: plyskin@yahoo.com
Study Contact Backup
- Name: Irina R Makarenko, MD
- Phone Number: +79032101254
- Email: makarenkoirina505@gmail.com
Study Locations
-
-
-
Moscow, Russian Federation, 127486
- Recruiting
- S.N. Fedorov Nmrc "Mntk "Eye Microsurgery"
-
Contact:
- Pavel V Lyskin, PhD
- Phone Number: +74994888926
- Email: plyskin@yahoo.com
-
Contact:
- Irina R Makarenko, MD
- Phone Number: +79032101254
- Email: makarenkoirina505@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- BCVA < 0,6;
Exclusion Criteria:.
- secondary ERM, glaucoma, diabetic retinopathy, high myopia, BCVA>0,6
Study Plan
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
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 124575
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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