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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06459284
Enrollment
55
Registered
2024-06-14
Start date
2024-06-03
Completion date
2024-12-31
Last updated
2025-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epiretinal Membrane

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.

Detailed description

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.

Interventions

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

Sponsors

Prim. Prof. Dr. Oliver Findl, MBA
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
occurrence of dipping into retinal tissue with the ILM forceps during graspingduring surgery, an average of 30 minutesoccurrence of dipping into retinal tissue during grasping will be evaluated (yes/no)
amount of dipping into retinal tissue with the ILM forceps during grasping, measured with ImageJduring surgery, an average of 30 minutesamount of dipping into retinal tissue will be measured with calipers in ImageJ

Secondary

MeasureTime frameDescription
anatomical changes at the grasp site measured with optical coherence tomography3 monthsanatomical changes in retinal layers at the grasp site will be examinded by optical coherence tomography (yes/no)

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026