Ignite Creation Date:
2024-05-06 @ 3:28 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04647929
Status:
WITHDRAWN
Last Update Posted:
2023-06-05
First Post:
2020-11-16
Brief Title:
Comparison of Surgical Treatment Options for Primary Congenital and Developmental Glaucomas
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
Comparison of Surgical Treatment Options for Primary Congenital and Developmental Glaucomas
Status:
WITHDRAWN
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding for the study could not be found
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STOP-Glaucoma
Brief Summary:
Newborn and children can be affected by two subgroups of this disease 1 primary congenital glaucoma PCG or 2 developmental glaucoma DG The primary aim of this study is to compare the Santen PRESERFLO implant to trabeculectomy in PCG and DG patients as second surgery after failed trabeculotomy or goniotomy
Detailed Description:
Glaucoma is a chronic progressive disease leading to blindness if untreated or insufficiently treated It is characterized by a loss of optic nerve fiber and a glaucomatous optic disc excavation and a corresponding pattern of visual field loss Newborn and children can be affected by two subgroups of this disease 1 primary congenital glaucoma PCG or 2 developmental glaucoma DG PCG and DG are treated surgically either by goniotomy or by trabeculotomy as first approach and not with topical hypotensive medications Whenever these procedures have failed the subsequent surgical procedure is usually trabeculectomy with Mitomycin C or the implantation of a glaucoma drainage device However there is a lack of evidence regarding the optimal surgical approach after failed goniotomytrabeculotomy Optimal treatment in this young group of patients with a long life expectancy is crucial to prevent blindness allow them to participate in a normal school and work environment and to minimize disease burdens for these patients and their families as well as to minimize costs for society Consequently there is the desire to find a procedure with a superior success rate and even fewer or less severe complications compared to trabeculectomy Recently the Santen PRESERFLO was introduced The results proved fewer complications and comparable efficacy to trabeculectomy according results presented at scientific meetings Yet there are no published studies to compare the both procedures The primary aim of this study is to compare the Santen PRESERFLO implant to trabeculectomy in PCG and DG patients
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