Evaluation of the "Grasp Site" After Peeling of Epiretinal Membranes

Evaluation of the "Grasp Site" After Peeling of Epiretinal Membranes With Different ILM Forceps - a Prospective Randomized Study

The goal of this study is to compare the novel ILM sharkskin forceps with a conventional ILM forceps utilizing iOCT assistance during surgery at this "grasp site". The main questions it aims to answer are:

1. are there differences in grasp attempts between both forceps
2. are there differences in Instrument tissue interactions between both forceps
3. are there differences in postsurgical anatomical and functional outcomes at the grasp site between both forceps.

Study Overview

• Status: Completed
• Conditions: Epiretinal Membrane
• Intervention / Treatment: Device: ILM forceps - membrane grasping

Detailed Description

Epiretinal membranes are a disease of the retinal surface, that may affect visual acuity acuity and cause metamorphopsia, occurring in approximately 20% of the population older than 60 years. Using vitrectomy with membrane peeling, postoperative improvement of visual acuity and metamorphopsia may be achieved in a majority of patients. The surgical method has been used for some time, the first report on the surgical method of vitrectomy with membrane peeling dates back to 1978, and since the introduction of intraoperative optical coherence tomography (iOCT), intraoperative iatrogenically induced changes in retinal tissue can be detected and correlated with postoperative changes. Our group has been able to record "stretching" of the retinal tissue using this technique and has also been able to record the rarely occurring subfoveal and extrafoveal elevations of the ellipsoidal zone due to membrane peeling. These changes did not significantly affect postoperative visual acuity in our study population but did affect the development of postoperative microscotomas. Besides "retinal stretching" during surgery, ILM peeling is shown to be another factor with association of new postoperative microscotomas. New postoperative microscotomas developed in some patients without "retinal stretching" and ILM peeling. Apart from these already known iatrogenic changes, the analysis of the "grasp site" at the "starting point" of epiretinal membrane peeling is of great interest, because at this location, grasping of the epiretinal membrane may be difficult especially in case of an adherent ERM and superficial retinal lesions may be induced.

Diaz et al. demonstrated that there are postoperative changes in the "nerve fiber layer" after ILM peeling, but in that study, no recording of instrument/tissue interactions was performed using iOCT.

The aim of this study is to compare the novel ILM sharkskin forceps with a conventional ILM forceps utilizing iOCT assistance during surgery at this "grasp site".

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1140
    • Hanusch Hospital, Department of Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Idiopathic ERM
• Sheduled surgery (vitrectomy with membrane peeling), as defined by vision loss and/or metamorphopsia
• Age 18 and older
• Written informed consent for participation in the study

Exclusion Criteria:

• Macular edema due to other reasons than iERM
• Pregnancy (pregnancy test will be performed in women of reproductive age)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ILM sharkskin forceps; Patients were operated on using an ILM forceps with a laser-modified microstructure on the branches.	Device: ILM forceps - membrane grasping; grasping the epiretinal membrane at the starting location, using pinch peeling, is performed with an ILM forceps.
Active Comparator: conventional ILM forceps; Patients were operated on using a conventional ILM forceps with plain surfaces on the branches.	Device: ILM forceps - membrane grasping; grasping the epiretinal membrane at the starting location, using pinch peeling, is performed with an ILM forceps.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
grasp attempts	number of attemps needed for opening the epiretinal membrane during grasping	during surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
metamorphopsia	Presence of metamorphopsia is tested with the Amsler grid and M-charts	before and 3 months after surgery
microscotomata	New deep microscotomata is tested with microperimetry	before and 3 months after surgery
Thinning of the ganglion cell layer	Thinning of the ganglion cell layer is assessed with optical coherence tomography	before and 3 months after surgery
Central subfield thickness	Central subfield thickness of the macula is assessed with optical coherence tomography	before and 3 months after surgery
Best corrected distant visual acuity	Best corrected distant visual acuity is assessed by EDTRS-charts	before and 3 months after surgery
OCT biomarkers	OCT biomarkers are assessed by optical coherence tomography	before surgery

Collaborators and Investigators

• Sponsor: Prim. Prof. Dr. Oliver Findl, MBA
• Investigators: Principal Investigator: Christoph Leisser, MD, Mein Hanusch-Krankenhaus

Publications and helpful links

General Publications

• Mitchell P, Smith W, Chey T, Wang JJ, Chang A. Prevalence and associations of epiretinal membranes. The Blue Mountains Eye Study, Australia. Ophthalmology. 1997 Jun;104(6):1033-40. doi: 10.1016/s0161-6420(97)30190-0.
• Machemer R. [The surgical removal of epiretinal macular membranes (macular puckers) (author's transl)]. Klin Monbl Augenheilkd. 1978 Jul;173(1):36-42. German.
• Leisser C, Palkovits S, Hienert J, Ullrich M, Zwickl H, Georgiev S, Findl O. Effect of Iatrogenic Traction during Macular Peeling Surgery on Postoperative Microperimetry. Ophthalmic Res. 2021;64(2):273-279. doi: 10.1159/000507633. Epub 2020 Apr 1.
• Leisser C, Hackl C, Hirnschall N, Findl O. Effect of Subfoveal and Extrafoveal Hyporeflective Zones due to Iatrogenic Traction during Membrane Peeling for Epiretinal Membranes on Postoperative Outcomes. Ophthalmologica. 2020;243(4):297-302. doi: 10.1159/000505214. Epub 2019 Dec 5.
• Diaz RI, Randolph JC, Sigler EJ, Calzada JI. Intraoperative grasp site correlation with morphologic changes in retinal nerve fiber layer after internal limiting membrane peeling. Ophthalmic Surg Lasers Imaging Retina. 2014 Jan-Feb;45(1):45-9. doi: 10.3928/23258160-20131220-06.

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2023
• Primary Completion (Actual): December 1, 2024
• Study Completion (Actual): December 1, 2024

Study Registration Dates

• First Submitted: December 21, 2024
• First Submitted That Met QC Criteria: December 21, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Epiretinal Membrane
• Other Study ID Numbers: SIF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No