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Completed

NCT Number: NCT06459284

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vienna Institute for Research in Ocular Surgery

Vienna, 1140, Austria

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: during surgery, an average of 30 minutes

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

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

    Time frame: during surgery, an average of 30 minutes

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

Secondary outcomes

  1. anatomical changes at the grasp site measured with optical coherence tomography

    Time frame: 3 months

    anatomical changes in retinal layers at the grasp site will be examinded by optical coherence tomography (yes/no)

Sponsors and collaborators

Lead sponsor

Prim. Prof. Dr. Oliver Findl, MBA

Other

Registry information

Official study title

Instrument Tissue Interaction at the Grasp Site During Membrane Peeling of Epiretinal Membranes - a Retrospective Exploratory Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 14, 2024
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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