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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:
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".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ILM sharkskin forceps | Experimental | Patients were operated on using an ILM forceps with a laser-modified microstructure on the branches. |
|
| conventional ILM forceps | Active Comparator | Patients were operated on using a conventional ILM forceps with plain surfaces on the branches. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ILM forceps - membrane grasping | Device | grasping the epiretinal membrane at the starting location, using pinch peeling, is performed with an ILM forceps. |
|
| Measure | Description | Time Frame |
|---|---|---|
| grasp attempts | number of attemps needed for opening the epiretinal membrane during grasping | during surgery |
| Measure | Description | Time Frame |
|---|---|---|
| metamorphopsia | Presence of metamorphopsia is tested with the Amsler grid and M-charts | before and 3 months after surgery |
| microscotomata | New deep microscotomata is tested with microperimetry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Leisser, MD | Mein Hanusch-Krankenhaus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanusch Hospital, Department of Ophthalmology | Vienna | 1140 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9186446 | Background | 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. | |
| 692034 | Background | Machemer R. [The surgical removal of epiretinal macular membranes (macular puckers) (author's transl)]. Klin Monbl Augenheilkd. 1978 Jul;173(1):36-42. German. |
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| ID | Term |
|---|---|
| D019773 | Epiretinal Membrane |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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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.
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| before and 3 months after surgery |
| Thinning of the ganglion cell layer | Thinning of the ganglion cell layer is assessed with optical coherence tomography | before and 3 months after surgery |
| Central subfield thickness | Central subfield thickness of the macula is assessed with optical coherence tomography | before and 3 months after surgery |
| Best corrected distant visual acuity | Best corrected distant visual acuity is assessed by EDTRS-charts | before and 3 months after surgery |
| OCT biomarkers | OCT biomarkers are assessed by optical coherence tomography | before surgery |
| 32235121 | Background | 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. |
| 31801147 | Background | 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. |
| 24392911 | Background | 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. |