Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05904613
Status:
COMPLETED
Last Update Posted:
2023-06-29
First Post:
2023-06-06
Brief Title:
Evaluation of the Impact of the XEN Implant on Endothelial Cell Density 3 Years After Surgery
Sponsor:
Fondation Hôpital Saint-Joseph
Organization:
Fondation Hôpital Saint-Joseph
Study Overview
Official Title:
Retrospective Study Evaluating the Impact of the XEN Implant on Endothelial Cell Density Measured Using Specular Microscopy at 3 Years After Surgery
Status:
COMPLETED
Status Verified Date:
2023-06
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:
RETROXEN
Brief Summary:
Glaucoma is a blinding optic neuropathy affecting 80 million people worldwide with primary open-angle glaucoma being the most common etiology Today the therapeutic arsenal includes drug-based hypotonizing treatments lasers and surgery In France the most common surgical techniques are trabeculectomy and deep non-perforating sclerectomy SPNP The principle behind these filtering techniques is to lower intraocular pressure IOP by creating an escape route for aqueous humor from the anterior chamber AC of the eye into the subconjunctival space creating a filtration bubble FB
A new minimally invasive treatment option has been developed to limit intra- and post-operative complications This new technique is based on an ab interno approach with implantation through the anterior chamber of a 6mm-long 45µm-lumen collagen tube called XEN As a result there is no dissection of the conjunctivotenone planes as is the case in traditional surgery
Since June 2017 surgeons have been able to use the XEN technique in the ophthalmology department at GHPSJ
Today no study has yet assessed endothelial cell loss more than 2 years after this surgery Indeed the presence of an anterior chamber device of any type can be associated with endothelial cell loss which increases over time well after the surgical procedure and may require removal of the device several years after surgery
Recent studies have investigated peripheral endothelial cell loss with other drainage systems They show a significant decrease in peripheral endothelial cell density in relation to the implant placed in the anterior chamber The aim of this study is to evaluate central and peripheral endothelial cell density in the long term after XEN placement At the visit more than 3 years after XEN implant placement IOP and pachymetry measurements were taken along with a measurement of peripheral and central endothelial cell density Corneal peripheral endothelial cell density is measured on the different quadrants of the treated eye as well as on the controlateral eye Measurements will be made for each eye for patients undergoing surgery on both eyes
A new minimally invasive treatment option has been developed to limit intra- and post-operative complications This new technique is based on an ab interno approach with implantation through the anterior chamber of a 6mm-long 45µm-lumen collagen tube called XEN As a result there is no dissection of the conjunctivotenone planes as is the case in traditional surgery
Since June 2017 surgeons have been able to use the XEN technique in the ophthalmology department at GHPSJ
Today no study has yet assessed endothelial cell loss more than 2 years after this surgery Indeed the presence of an anterior chamber device of any type can be associated with endothelial cell loss which increases over time well after the surgical procedure and may require removal of the device several years after surgery
Recent studies have investigated peripheral endothelial cell loss with other drainage systems They show a significant decrease in peripheral endothelial cell density in relation to the implant placed in the anterior chamber The aim of this study is to evaluate central and peripheral endothelial cell density in the long term after XEN placement At the visit more than 3 years after XEN implant placement IOP and pachymetry measurements were taken along with a measurement of peripheral and central endothelial cell density Corneal peripheral endothelial cell density is measured on the different quadrants of the treated eye as well as on the controlateral eye Measurements will be made for each eye for patients undergoing surgery on both eyes
Detailed Description:
Glaucoma is a blinding optic neuropathy affecting 80 million people worldwide with primary open-angle glaucoma being the most common etiology Today the therapeutic arsenal includes drug-based hypotonizing treatments lasers and surgery In France the most common surgical techniques for glaucoma are trabeculectomy and deep non-perforating sclerectomy SPNP These are two filtering techniques designed to lower intraocular pressure IOP by creating an escape route for aqueous humor from the anterior chamber AC of the eye into the subconjunctival space creating a filtering bubble FB They can be performed alone or at the same time as cataract surgery The short-term complications encountered with these techniques are early hypotony and its attendant complications choroidal detachment hypotonic maculopathy haemorrhages etc the most frequent cause of which is conjunctival leakage of the bubble In the medium term tension rises with a deep anterior chamber are evidence of an over-tight scleral flap which may require suture lysis Finally problems of excessive conjunctivotenone scarring affect 25 to 30 of patients and are responsible for the majority of late tension increases In the longer term the most frequent complication is cataract The rarest but most serious complication is infection of the BF which occurs more frequently when the walls of the BF are ischemic or perforated It can be complicated by endophthalmitis which can lead to irreversible loss of visual acuity
A new minimally invasive treatment option has been developed to limit intra- and post-operative complications This new technique is based on an ab interno approach with implantation through the anterior chamber of a 6mm-long 45µm-lumen collagen tube called XEN There is no need to dissect the conjunctivotenon planes as is the case with traditional surgery
The geometry of the XEN implant has been designed to prevent major hypotonia This new technique avoids the complications associated with conjunctival dissection while being faster and offering a standardized surgical technique Today XEN implant placement is used in simple surgery or combined with cataract surgery for open-angle glaucoma incipient to moderate associated or not with a cataract progressive and unbalanced under local hypotonizing treatment
Since June 2017 surgeons have been able to use the XEN technique in the GHPSJ ophthalmology department
To date no study has assessed endothelial cell loss more than 2 years after this surgery Indeed the presence of an anterior chamber device of any type may be associated with endothelial cell loss that increases over time well after the operation and may require removal of the device several years after the operation One study showed that the microinvasive ab interno Alcon Cypass device a device similar to XEN caused significant endothelial cell loss 2 years after device implantation and was unacceptable compared with conventional glaucoma surgery The damage was proportional to the surface area of the implant in the anterior chamber and led to the immediate withdrawal of the device from the market
Recent studies have examined peripheral endothelial cell loss with other drainage systems They show a significant reduction in peripheral endothelial cell density in relation to the implant placed in the anterior chamber Intracameral devices appear to have an impact on endothelial integrity To date no study has assessed long-term central and peripheral endothelial cell density after XEN placement
At the visit more than 3 years after XEN implantation intraocular pressure IOP is measured with a Goldmann applanation tonometer pachymetry with a NIDEK automatic refractometer and central and peripheral endothelial cell density with a NIDEK specular microscope Peripheral corneal endothelial cell density is measured on the various ocular quadrants The same measurements are taken on the controlateral eye Patients undergoing surgery on both eyes receive the same measurements for each eye
A new minimally invasive treatment option has been developed to limit intra- and post-operative complications This new technique is based on an ab interno approach with implantation through the anterior chamber of a 6mm-long 45µm-lumen collagen tube called XEN There is no need to dissect the conjunctivotenon planes as is the case with traditional surgery
The geometry of the XEN implant has been designed to prevent major hypotonia This new technique avoids the complications associated with conjunctival dissection while being faster and offering a standardized surgical technique Today XEN implant placement is used in simple surgery or combined with cataract surgery for open-angle glaucoma incipient to moderate associated or not with a cataract progressive and unbalanced under local hypotonizing treatment
Since June 2017 surgeons have been able to use the XEN technique in the GHPSJ ophthalmology department
To date no study has assessed endothelial cell loss more than 2 years after this surgery Indeed the presence of an anterior chamber device of any type may be associated with endothelial cell loss that increases over time well after the operation and may require removal of the device several years after the operation One study showed that the microinvasive ab interno Alcon Cypass device a device similar to XEN caused significant endothelial cell loss 2 years after device implantation and was unacceptable compared with conventional glaucoma surgery The damage was proportional to the surface area of the implant in the anterior chamber and led to the immediate withdrawal of the device from the market
Recent studies have examined peripheral endothelial cell loss with other drainage systems They show a significant reduction in peripheral endothelial cell density in relation to the implant placed in the anterior chamber Intracameral devices appear to have an impact on endothelial integrity To date no study has assessed long-term central and peripheral endothelial cell density after XEN placement
At the visit more than 3 years after XEN implantation intraocular pressure IOP is measured with a Goldmann applanation tonometer pachymetry with a NIDEK automatic refractometer and central and peripheral endothelial cell density with a NIDEK specular microscope Peripheral corneal endothelial cell density is measured on the various ocular quadrants The same measurements are taken on the controlateral eye Patients undergoing surgery on both eyes receive the same measurements for each eye
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