Evaluation of the Impact of the XEN® Implant on Endothelial Cell Density, 3 Years After Surgery

NCT05904613 | Completed

• 1 other identifier: RETROXEN
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Keywords

glaucoma; Xen implant

Outcome Measures

Primary Outcomes (1)

• assessment of long-term (>3years) central and peripheral endothelial cell density after XEN® placement.

  Difference in central and peripheral endothelial cell density between the upper nasal quadrant and the other quadrant (lower nasal, upper and lower temporal quadrant)

  at least 3 years after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated for primary open-angle glaucoma, normal-pressure glaucoma, pigmentary glaucoma or secondary glaucoma in the ophthalmology department of the Paris Saint-Joseph hospital group.

You may qualify if:

• Male or female ≥ 18 years of age
• French-speaking patient
• Patients treated for primary open-angle glaucoma, normal-pressure glaucoma, pigmentary glaucoma or secondary glaucoma in the ophthalmology department of the Paris Saint-Joseph hospital group.
• Patients who have undergone surgery with XEN® alone or in combination with cataract surgery by lens phacoemulsification, for one or both eyes.

You may not qualify if:

• Patient with any other associated ophthalmological disease, other than simple cataract already operated on or operated on simultaneously with XEN® application, with no intra- or postoperative complications
• History of filtering surgery prior to XEN® treatment
• Filtering surgery after XEN® treatment
• History of vitrectomy (removal of the vitreous body from the eye)
• Angle-closure glaucoma
• Uveitic glaucoma (linked to inflammation which may itself have an effect on the cornea)
• Pre-existing endothelial dystrophy, iridocorneoendothelial syndrome (ICE) (glaucoma with corneal pathology)
• Endothelial cell count below 1000 cells
• Patient under guardianship or curatorship
• Patient deprived of liberty
• Patient under court protection.

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 15, 2023
• Study Start: October 9, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 29, 2023

Record last verified: 2023-06

Locations

FR (1)