Evaluation of the Xen Implant in Glaucoma Surgery

NCT03733600 | Completed

• 1 other identifier: XEN
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• Evaluation of the efficiency of surgery with Xen

  The success of surgery will be evaluate with the intra-ocular pressure's measurement. Complete success corresponds to Intra-ocular pressure between 5 and 18 mmHg, with a relative decrease of more than 20% compared to the initial intra-ocular pressure, without having resorted to hypotonic treatments. Partial success corresponds to intra-ocular pressure between 5 and 18 mmHg but with an intra-ocular pressure reduction of less than 20% or with maintenance of a hypotonizing treatment. Therapeutic failure is defined as an intra-ocular pressure strictly greater than 18 mmHg or less than 5 mmHg.

  year 1

Secondary Outcomes (6)

• Evaluation of visual activity

  year 1

• Evaluation of visual fieldwill

  year 1

• Measurement of Optic nerve excavation

  year 1

• Evaluation of the efficiency of Xen

  year 1

• Evaluation of post-operative complications

  year 1

Study Arms (1)

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.

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

Patient, operated between June 2017 and June 2018, 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.

You may qualify if:

• 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

You may not qualify if:

• 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

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 Officials

• Yves P LACHKAR, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 7, 2018
• Study Start: June 15, 2018
• Primary Completion: June 30, 2019
• Study Completion: April 26, 2023
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

FR (1)