Clinical trial NCT06753539: Evaluation of the "Grasp Site" After Peeling of Epiretinal Membranes
Official title: Evaluation of the "Grasp Site" After Peeling of Epiretinal Membranes With Different ILM Forceps - a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epiretinal Membrane
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were operated on using either an ILM forceps with a laser-modified microstructure on the branches (group A) or a conventional ILM forceps (group B). Patients are randomized to both groups.
Primary purpose: TREATMENT

Brief summary: The goal of this study is to compare the novel ILM sharkskin forceps with a conventional ILM forceps utilizing iOCT assistance during surgery at this "grasp site". The main questions it aims to answer are:

1. are there differences in grasp attempts between both forceps
2. are there differences in Instrument tissue interactions between both forceps
3. are there differences in postsurgical anatomical and functional outcomes at the grasp site between both forceps.

Detailed description: Epiretinal membranes are a disease of the retinal surface, that may affect visual acuity acuity and cause metamorphopsia, occurring in approximately 20% of the population older than 60 years. 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 dates back to 1978, and since the introduction of intraoperative optical coherence tomography (iOCT), intraoperative iatrogenically induced changes in retinal tissue can be detected and correlated with postoperative changes. Our group 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 in our study population but did affect the development of postoperative microscotomas. Besides "retinal stretching" during surgery, ILM peeling is shown to be another factor with association of new postoperative microscotomas. New postoperative microscotomas developed in some patients without "retinal stretching" and ILM peeling. Apart from these already known iatrogenic changes, the analysis of the "grasp site" at the "starting point" of epiretinal membrane peeling is of great interest, because at this location, grasping of the epiretinal membrane may be difficult especially in case of an adherent ERM and superficial retinal lesions may be induced.

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 compare the novel ILM sharkskin forceps with a conventional ILM forceps utilizing iOCT assistance during surgery at this "grasp site".

Eligibility criteria: Inclusion Criteria:

* Idiopathic ERM
* Sheduled surgery (vitrectomy with membrane peeling), as defined by vision loss and/or metamorphopsia
* Age 18 and older
* Written informed consent for participation in the study

Exclusion Criteria:

* Macular edema due to other reasons than iERM
* Pregnancy (pregnancy test will be performed in women of reproductive age)

Primary outcomes:
measure: grasp attempts
timeFrame: during surgery
Secondary outcomes:
measure: metamorphopsia
timeFrame: before and 3 months after surgery
measure: microscotomata
timeFrame: before and 3 months after surgery
measure: Thinning of the ganglion cell layer
timeFrame: before and 3 months after surgery
measure: Central subfield thickness
timeFrame: before and 3 months after surgery
measure: Best corrected distant visual acuity
timeFrame: before and 3 months after surgery
measure: OCT biomarkers
timeFrame: before surgery
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Hanusch Hospital, Department of Ophthalmology
Study officials:
affiliation: Mein Hanusch-Krankenhaus
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.