An interventional study of ILM forceps - membrane grasping in Epiretinal Membrane, sponsored by Prim. Prof. Dr. Oliver Findl, MBA. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-13.
Sponsored by Prim. Prof. Dr. Oliver Findl, MBA · Not applicable, Interventional, and Treatment
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".
120 studies on the registry are indexed under Epiretinal Membrane; 14 are open to participants now.
This study's enrollment of 58 is above the median of 50 across 73 interventional studies indexed under Epiretinal Membrane.
Browse Epiretinal Membrane studies →Prim. Prof. Dr. Oliver Findl, MBA is the lead sponsor of 38 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Patients were operated on using an ILM forceps with a laser-modified microstructure on the branches.
Device: ILM forceps - membrane grasping
Patients were operated on using a conventional ILM forceps with plain surfaces on the branches.
Device: ILM forceps - membrane grasping
grasping the epiretinal membrane at the starting location, using pinch peeling, is performed with an ILM forceps.
grasp attempts
number of attemps needed for opening the epiretinal membrane during grasping
Time frame: during surgery
metamorphopsia
Presence of metamorphopsia is tested with the Amsler grid and M-charts
Time frame: before and 3 months after surgery
microscotomata
New deep microscotomata is tested with microperimetry
Time frame: before and 3 months after surgery
Thinning of the ganglion cell layer
Thinning of the ganglion cell layer is assessed with optical coherence tomography
Time frame: before and 3 months after surgery
Central subfield thickness
Central subfield thickness of the macula is assessed with optical coherence tomography
Time frame: before and 3 months after surgery
Best corrected distant visual acuity
Best corrected distant visual acuity is assessed by EDTRS-charts
Time frame: before and 3 months after surgery
OCT biomarkers
OCT biomarkers are assessed by optical coherence tomography
Time frame: before surgery
Plan to share: No
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Prim. Prof. Dr. Oliver Findl, MBA