Intraoperative Analysis of the Central Retina in ERF

Intraoperative Analysis of the Central Retina in Epiretinal Fibrosis

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04802915

Enrollment

Registered

2021-03-17

Start date

2019-01-15

Completion date

2022-12-31

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epiretinal Membrane, Macular Pucker

Keywords

epiretinal membrane, internal limiting membrane, epiretinal fibrosis, macular pucker, central retina

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

Interventions

PROCEDUREIntraoperative 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 82 Years

Healthy volunteers

Inclusion criteria

* BCVA \< 0,6;

Exclusion criteria

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

Design outcomes

Primary

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

Countries

Russia

Contacts

Primary ContactPavel V Lyskin, PhD

plyskin@yahoo.com+74994888926

Backup ContactIrina R Makarenko, MD

makarenkoirina505@gmail.com+79032101254

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026