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

Epiretinal Membrane Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06459284
• Other study ID #: ITI
• Status: Active, not recruiting
• Start date: June 3, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Vienna Institute for Research in Ocular Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 55
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epiretinal Membrane

Intervention

Other:
• 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

Locations

Country	Name	City	State
Austria	Vienna Institute for Research in Ocular Surgery	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Prim. Prof. Dr. Oliver Findl, MBA

Country where clinical trial is conducted

Austria, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	anatomical changes at the grasp site measured with optical coherence tomography	anatomical changes in retinal layers at the grasp site will be examinded by optical coherence tomography (yes/no)	3 months