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

NCT06753539 | Completed

• 1 other identifier: SIF
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Epiretinal Membrane

Outcome Measures

Primary Outcomes (1)

• grasp attempts

  number of attemps needed for opening the epiretinal membrane during grasping

  during surgery

Secondary Outcomes (6)

• metamorphopsia

  before and 3 months after surgery

• microscotomata

  before and 3 months after surgery

• Thinning of the ganglion cell layer

  before and 3 months after surgery

• Central subfield thickness

  before and 3 months after surgery

• Best corrected distant visual acuity

  before and 3 months after surgery

Study Arms (2)

ILM sharkskin forceps

EXPERIMENTAL

Patients were operated on using an ILM forceps with a laser-modified microstructure on the branches.

Device: ILM forceps - membrane grasping

conventional ILM forceps

ACTIVE COMPARATOR

Patients were operated on using a conventional ILM forceps with plain surfaces on the branches.

Device: ILM forceps - membrane grasping

Interventions

ILM forceps - membrane grasping DEVICE

grasping the epiretinal membrane at the starting location, using pinch peeling, is performed with an ILM forceps.

ILM sharkskin forceps; conventional ILM forceps

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Prim. Prof. Dr. Oliver Findl, MBA: lead

Study Sites (1)

Hanusch Hospital, Department of Ophthalmology

Vienna, 1140, Austria

Location

Related Publications (5)

• 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.

  PMID: 9186446 BACKGROUND

• Machemer R. [The surgical removal of epiretinal macular membranes (macular puckers) (author's transl)]. Klin Monbl Augenheilkd. 1978 Jul;173(1):36-42. German.

  PMID: 692034 BACKGROUND

• 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.

  PMID: 32235121 BACKGROUND

• 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.

  PMID: 31801147 BACKGROUND

• 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.

  PMID: 24392911 BACKGROUND

MeSH Terms

Conditions

Epiretinal Membrane

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Christoph Leisser, MD

  Mein Hanusch-Krankenhaus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prim. Prof. Dr. Oliver Findl, MBA, Sponsor of the study

Model Details: Patients were operated on using either an ILM forceps with a laser-modified microstructure on the branches (group A) or a conventional ILM forceps (group B). Patients are randomized to both groups.

Study Record Dates

• First Submitted: December 21, 2024
• First Posted: December 31, 2024
• Study Start: May 12, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)