Evolution of EIFL Following PPV

• Sponsor: Kocaeli University (Other)
• Overall Status: Completed
• CT.gov ID: NCT06040216
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Actual Duration (Months): 2
• Patients Per Site Per Month: 39.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epiretinal Membrane	Other: optical coherence tomography

Study Design

• Study Type: Observational
• Actual Enrollment: 80 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Long-term Follow-up Results of Ectopic Inner Foveal Retinal Layers Evolution Following Pars Plana Vitrectomy
• Actual Study Start Date: Jan 15, 2020
• Actual Primary Completion Date: Mar 17, 2020
• Actual Study Completion Date: Mar 17, 2020

Arms and Interventions

Arm	Intervention/Treatment
Stage 2 ERM	Other: optical coherence tomography; We observed the postoperative improvement in EIFL severity with optical coherence tomography
Stage 3 ERM	Other: optical coherence tomography; We observed the postoperative improvement in EIFL severity with optical coherence tomography
Stage 4 ERM	Other: optical coherence tomography; We observed the postoperative improvement in EIFL severity with optical coherence tomography

Outcome Measures

Primary Outcome Measures

1. Best corrected visual acuity [1-month]

   Best corrected visual acuity

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients undergoing idiopathic epiretinal membrane surgery

Exclusion Criteria:

• Patients undergoing seconder epiretinal membrane surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kocaeli University School of Medicine	Kocaeli	None Selected	Turkey	41001

Sponsors and Collaborators

• Kocaeli University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Levent Karabas, Prof. Dr., Kocaeli University
• ClinicalTrials.gov Identifier: NCT06040216
• Other Study ID Numbers: KocaeliUniversity
• First Posted: Sep 15, 2023
• Last Update Posted: Sep 15, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Epiretinal Membrane

Study Results

No Results Posted as of Sep 15, 2023