NCT06040216

Brief Summary

Various classification systems have been described for epiretinal membrane (ERM). One of them is a new OCT-based staging scheme based on displacement and reorganization of inner retinal layers called ectopic inner retinal layers (EIFL). We evaluated pre-and perioperative factors related to time for evolution of EIFL.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2020

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 15, 2023

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

2 months

First QC Date

September 10, 2023

Last Update Submit

September 10, 2023

Conditions

Epiretinal Membrane

Outcome Measures

Primary Outcomes (1)

  • Best corrected visual acuity

    Best corrected visual acuity

    1-month

Study Arms (3)

Stage 2 ERM

Other: optical coherence tomography

Stage 3 ERM

Other: optical coherence tomography

Stage 4 ERM

Other: optical coherence tomography

Interventions

optical coherence tomographyOTHER

We observed the postoperative improvement in EIFL severity with optical coherence tomography

Stage 2 ERMStage 3 ERMStage 4 ERM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This retrospective study included 81 consecutive eyes with idiopathic epiretinal membrane that underwent vitrectomy surgery.

You may qualify if:

  • Patients undergoing idiopathic epiretinal membrane surgery

You may not qualify if:

  • Patients undergoing seconder epiretinal membrane surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University School of Medicine

Kocaeli, None Selected, 41001, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Epiretinal Membrane

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

September 10, 2023

First Posted

September 15, 2023

Study Start

January 15, 2020

Primary Completion

March 17, 2020

Study Completion

March 17, 2020

Last Updated

September 15, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)