Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04767555
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-24
First Post:
2021-02-17
Brief Title:
Impact of ILM Peeling in RRD I-Peel
Sponsor:
Berner Augenklinik
Organization:
Berner Augenklinik
Study Overview
Official Title:
Impact of ILM Peeling on Functional and Anatomic Outcomes of Vitrectomy for Primary Rhegmatogenous Retinal Detachment - the I-Peel Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
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:
I-Peel
Brief Summary:
Retinal detachment is associated with a substantial risk of re-detachment in 10-20 and to the formation of secondary epiretinal membranes in up to 15 Relevant postoperative vision loss is encountered in many instances primarily in consequence of macular involvement but also secondarily due to postoperative complications namely the formation of an epiretinal membrane and proliferative vitreoretinopathy These mechanical reasons of influence can potentially be prevented by ILM peeling during reattachment surgery This however is not a generally accepted standard of care during primary routine vitrectomy
Two groups suffering from primary retinal detachment will be compared the first group will receive standard re-attachment vitrectomy surgery whereas the second group will receive an identical vitrectomy surgery but with additional ILM peeling In this study the investigators wish to assess the influence of ILM peeling on visual outcomes and postoperative complications over 12 months
Two groups suffering from primary retinal detachment will be compared the first group will receive standard re-attachment vitrectomy surgery whereas the second group will receive an identical vitrectomy surgery but with additional ILM peeling In this study the investigators wish to assess the influence of ILM peeling on visual outcomes and postoperative complications over 12 months
Detailed Description:
None
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