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

NCT ID: NCT06459284

Last Updated: 2025-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-03

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Epiretinal membranes are a disease of the retinal surface, that may affect visual acuity and cause metamorphopsia, occurring in approximately 20% of the population older than 60 years, as reported by Mitchell et al.. 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 was published by Machemer and dates back to 1978. Since the introduction of intraoperative optical coherence tomography (iOCT), intraoperative iatrogenically induced changes in retinal tissue can be detected and correlated with postoperative changes. Leisser et al. 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, according to Leisser et al., but did affect the development of postoperative microscotomas. Nevertheless, iOCT has the potential to document instrument tissue interactions such as dipping into retinal tissue with the forceps during grasping of the ERM at the starting point of membrane peeling. 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

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Epiretinal Membrane

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

retrospective data analysis

Intervention Type 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

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.

retrospective data analysis

Intervention Type 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

Interventions

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retrospective data analysis

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* iOCT was not used during surgery
* bad image quality, excluding analysis of images
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prim. Prof. Dr. Oliver Findl, MBA

OTHER

Sponsor Role lead

Responsible Party

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Prim. Prof. Dr. Oliver Findl, MBA

Prof. Dr. Oliver Findl, MBA

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Christoph Leisser, MD

Role: PRINCIPAL_INVESTIGATOR

Vienna Institute for Research in Ocular Surgery

Locations

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Vienna Institute for Research in Ocular Surgery

Vienna, , Austria

Site Status

Countries

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Austria

References

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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.

Reference Type BACKGROUND
PMID: 9186446 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 692034 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32235121 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31801147 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24392911 (View on PubMed)

Other Identifiers

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ITI

Identifier Type: -

Identifier Source: org_study_id

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