Instrument Tissue Interaction at the Grasp Site During Membrane Peeling of Epiretinal Membranes

NCT06459284 | Completed

• 1 other identifier: ITI
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Epiretinal membranes are a disease of the retinal surface, that may affect visual acuity and cause metamorphopsia. Using vitrectomy with membrane peeling, postoperative improvement of visual acuity and metamorphopsia may be achieved in a majority of patients. 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 examine dipping into retinal tissue with the forceps during grasping of the epiretinal membrane at the starting point of peeling with iOCT.

Conditions

Epiretinal Membrane

Outcome Measures

Primary Outcomes (2)

• occurrence of dipping into retinal tissue with the ILM forceps during grasping

  occurrence of dipping into retinal tissue during grasping will be evaluated (yes/no)

  during surgery, an average of 30 minutes

• amount of dipping into retinal tissue with the ILM forceps during grasping, measured with ImageJ

  amount of dipping into retinal tissue will be measured with calipers in ImageJ

  during surgery, an average of 30 minutes

Secondary Outcomes (1)

• anatomical changes at the grasp site measured with optical coherence tomography

  3 months

Study Arms (2)

early use of iOCT group

Patients having undergone pars plana vitrectomy with membrane Peeling die to an epiretinal Membrane in the time period from 1.6.2014 to 31.12.2016.

Other: retrospective data analysis

later use of iOCT group

Patients having undergone pars plana vitrectomy with membrane Peeling die to an epiretinal Membrane in the time period from 1.11.2020 to 31.7.2022.

Other: retrospective data analysis

Interventions

retrospective data analysis OTHER

Surgical video-documentation including continous iOCT will ne reviewed for Instrument tissue interactions at the grasp site of the starting point of Membrane peeling

early use of iOCT group; later use of iOCT group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Medical records of patients having undergone pars plana vitrectomy with Membrane Peeling and surgery assisted with iOCT in the time periods from 1.6.2014 to 31.12.2016 (early phase) or 1.11.2020 to 31.7.2022 (later phase) have been selected for data analysis.

You may qualify if:

• Vitrectomy with membrane peeling with iOCT assistance due to an ERM in the time-period from 1.6.2014 to 31.12.2016 (early phase) or 1.11.2020 to 31.7.2022.
• Age 18 and older

You may not qualify if:

• iOCT was not used during surgery
• bad image quality, excluding analysis of images

Sponsors & Collaborators

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

Study Sites (1)

Vienna Institute for Research in Ocular Surgery

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

  Vienna Institute for Research in Ocular Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. Oliver Findl, MBA

Study Record Dates

• First Submitted: June 2, 2024
• First Posted: June 14, 2024
• Study Start: June 3, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)