Evaluation of the Xen Implant in Glaucoma Surgery

NCT ID: NCT03733600

Last Updated: 2023-04-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 108 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-15
• Study Completion Date: 2023-04-26

Brief Summary

Glaucoma is a blinding optic neuropathy that affects 60 million people around the world. Primary open-angle glaucoma is the most common etiology. The therapeutic arsenal now includes medicated hypotonic treatments, lasers and surgery. The most common glaucoma surgery in France is trabeculectomy and non-perforating deep sclerectomy. These are two filtering surgeries whose principle is to lower the intraocular pressure by creating a way of evacuation of the aqueous humor from the anterior chamber of the eye to the space sub conjunctival creating a bubble of filtration. The short-term complications with these techniques are early hypotonia and its attendant complications (choroidal detachment, maculopathy of hypotonia, haemorrhage...). In the medium term, blood pressure with deep anterior chamber, testify to a scleral flap too tight which may require suture lysis. Finally, the problems of excessive conjunctivo-tenon healing affect 25 to 30% of operated and are responsible for the majority of late blood pressure. In the longer term, the most common complication is cataracts. It can be complicated by a very serious endophthalmitis. A new minimally invasive therapeutic option has been developed that limits per and postoperative complications. In contrast to traditional techniques that have an ab externo approach, the ab interno approach of the proposed new technique involves the implantation of a collagen tube 6 mm in length and 45 μm of light called Xen® through the anterior chamber. This surgery can be performed alone or at the same time as a cataract surgery. The geometry of the Xen® implant has been studied to prevent major hypotonia. This new technique would also avoid the complications associated with conjunctival dissection, while being faster. A Xen® implant is nowadays indicated for simple surgery or combined with cataract surgery for open-angle, early-to-moderate, cataract and non-cataract glaucoma, progressive and unbalanced under local hypotonism therapy. Since June 2017, the Xen® technique is part of the routine at GhPSJ.

Detailed Description

The objective of this study is to evaluate the efficacy of surgery with Xen® implantation on intra-ocular pression drop in patients with primary or secondary open-angle glaucoma, beginner to moderate. The study will be proposed to all eligible patients operated between June 2017 and June 2018. After patient's non opposition, clinical data will be collected from patient's medical record.

Conditions

Glaucoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Glaucoma

All patients followed for either early or moderate forms of primary or secondary open-angle glaucoma who had undergone surgery for Xen alone or in combination with cataract surgery for phacoemulisation of the lens.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patient followed for either early or moderate forms of primary or secondary open-angle glaucoma who had undergone surgery for Xen® alone or in combination with cataract surgery for phacoemulisation of the lens
• Patients operated between June 2017 and June 2018

Exclusion Criteria

• Patient objecting to participate in the study
• Patient with other associated ophthalmological disease, except simple cataract already operated or operated simultaneously with the Xen® break without per or postoperative complication
• History of filter surgery, history of vitrectomy
• Close angle glaucoma
• Patient under tutorship or curatorship

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Hôpital Saint-Joseph

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yves P LACHKAR, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation Hôpital Saint-Joseph

Locations

Groupe Hospitalier Paris Saint-Joseph

Paris, , France

Countries

France

Other Identifiers

XEN

Identifier Type: -

Identifier Source: org_study_id