Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06459284
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-06-02
Brief Title:
Instrument Tissue Interaction at the Grasp Site During Membrane Peeling of Epiretinal Membranes
Sponsor:
Prim Prof Dr Oliver Findl MBA
Organization:
Vienna Institute for Research in Ocular Surgery
Study Overview
Official Title:
Instrument Tissue Interaction at the Grasp Site During Membrane Peeling of Epiretinal Membranes - a Retrospective Exploratory Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 instrumenttissue 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
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 instrumenttissue 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None