Clinical trial NCT06459284: Instrument Tissue Interaction at the Grasp Site During Membrane Peeling of Epiretinal Membranes
Official title: Instrument Tissue Interaction at the Grasp Site During Membrane Peeling of Epiretinal Membranes - a Retrospective Exploratory Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epiretinal Membrane
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: occurrence of dipping into retinal tissue with the ILM forceps during grasping
timeFrame: during surgery, an average of 30 minutes
measure: amount of dipping into retinal tissue with the ILM forceps during grasping, measured with ImageJ
timeFrame: during surgery, an average of 30 minutes
Secondary outcomes:
measure: anatomical changes at the grasp site measured with optical coherence tomography
timeFrame: 3 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery
Study officials:
affiliation: Vienna Institute for Research in Ocular Surgery
name: Christoph Leisser, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Machemer R. [The surgical removal of epiretinal macular membranes (macular puckers) (author's transl)]. Klin Monbl Augenheilkd. 1978 Jul;173(1):36-42. German.
citation: 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.
citation: 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.
citation: 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.