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Study Comparing the Kinetics of Endothelial Cell Loss Associated With the XEN® Implant Versus Traditional Filtering Surgery for Glaucoma

NCT04781283 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-02-01

No results posted yet for this study

Summary

Glaucoma is a blinding optic neuropathy that affects 60 million people worldwide. Of all the types of existing glaucoma, primary open-angle glaucoma is the most common etiology. The therapeutic arsenal today includes drug lowering treatments, lasers and surgery. The most frequent glaucoma surgeries are, in France, trabeculectomy and non-perforating deep sclerectomy (NPDS). These are two filtering surgeries whose principle is to lower the intra ocular pressure (IOP) by creating an evacuation path of the aqueous humor from the anterior chamber (AC) of the eye to the space subconjunctival creating a filtration bubble (FB). These two procedures are currently considered the gold standard. They can be performed alone or at the same time as cataract surgery. The short-term complications encountered with these techniques are early hypotonia and its attendant complications (choroidal detachment, hypotonic maculopathy, hemorrhages, etc.), the most common cause of which is conjunctival leakage from the bubble. In the medium term, increases in blood pressure with deep AC testify to a scleral flap that is too tight which may require suture lysis. Finally, the problems of excessive conjunctival-Tenon healing concern 25 to 30% of those operated on and are responsible for the majority of late blood pressure increases. In the longer term, the most common complication is cataracts; the rarest, but most serious complication is infection of BF, which occurs more readily when the walls of the FB are ischemic or even perforated. It can be complicated by an extremely serious endophthalmitis. A new minimally invasive therapeutic option has been developed limiting per- and post-operative complications. Unlike traditional techniques which present an ab externo approach, the ab interno approach of the new technique proposed consists of the implantation of a tube of collagen 6 mm in length and 45 µm of light called Xen® through the AC .

Conditions

Interventions

DEVICE

measurement of endothelial cell density by specular microscopy

During this first appointment (T0), in addition to the usual treatment, measurement of the endothelial cell density by specular microscopy will be carried out on the affected eye (basal cell density). To overcome the variability linked to the machine, three consecutive measurements will be taken; the average of the three measurements will be used. As part of his post-operative follow-up, the patient will be reviewed at one month, one year, two years, three years, four years and five years after the operation. During these consultations and as part of the research, a new determination of the cell density (3 consecutive measurements) by specular microscopy of the operated eye and an evaluation of the position of the XEN implant will be carried out each time. ® by OCT scan for patients having undergone this surgery.

Sponsors & Collaborators

  • Fondation Hôpital Saint-Joseph

    lead OTHER

Principal Investigators

  • Yves LACHKAR · Fondation Hôpital Saint-Joseph

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2021-11-15
Completion
2021-11-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04781283 on ClinicalTrials.gov