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

NCT04781283 | Withdrawn

• 1 other identifier: CINEXEN
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Glaucoma

Keywords

endothelial cell loss; XEN® implant; filtering surgery

Outcome Measures

Primary Outcomes (1)

• To assess the impact of the type of intervention (NPDS or XEN® placement) on endothelial cell loss 2 years after the intervention

  Difference between the two eye groups in terms of loss of endothelial cell density calculated relative to basal cell density

  2 years

Secondary Outcomes (22)

• Evaluate the impact of the type of intervention on endothelial cell loss after surgery procedure

  1 year postoperative

• Evaluate the impact of the type of intervention on endothelial cell loss after surgery procedure

  2 years postoperative

• Evaluate the impact of the type of intervention on endothelial cell loss after surgery procedure

  3 years postoperative

• Evaluate the impact of the type of intervention on endothelial cell loss after surgery procedure

  4 years postoperative

• Evaluate the impact of the type of intervention on endothelial cell loss after surgery procedure

  5 years postoperative

Study Arms (1)

specular microscopy

EXPERIMENTAL

The density measurement is a painless and very brief examination (less than a minute) during which the patient places his head on a chin rest while maintaining his forehead on a bar provided for this purpose while looking straight ahead. The measurements are then taken without contact with the patient's eye.

Device: measurement of endothelial cell density by specular microscopy

Interventions

measurement of endothelial cell density by specular microscopy DEVICE

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.

specular microscopy

Eligibility Criteria

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

You may qualify if:

• Man or woman aged ≥ 18 years
• French-speaking patient
• Patients followed for primary or secondary open-angle glaucoma in the ophthalmology department of the GhPSJ
• Patient with an indication for surgery with placement of Xen® or NDPS alone or combined with cataract surgery by phacoemulsification of the lens
• Patient affiliated to social security or, failing that, to another health insurance system
• Patient capable of giving free, informed and express consent.

You may not qualify if:

• Patient with another associated ophthalmological disease, apart from a simple cataract already operated on or operated simultaneously with NDPS or the Xen® break without complications during or after the operation
• History of filtering surgery, history of vitrectomy
• Closed-angle glaucoma
• Pseudo capsular exfoliation (connective tissue disease affecting the eye)
• Uveitic glaucoma (glaucoma related to inflammation which can itself have an effect on the cornea)
• Prolonged postoperative hypertonia (7 days)\> 40 mmHG (because this can damage the cells of the cornea)
• Pre-existing endothelial dystrophy, irido-corneo-endothelial syndrome (ICE) (glaucoma with corneal pathology)
• Postoperative athalamy (contact between the iris and the cornea generating endothelial cell loss)
• Endothelial cell count \<1000 cells
• Patient under guardianship or curatorship
• Patient deprived of liberty
• Patient under legal protection.

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Yves LACHKAR

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 4, 2021
• Study Start: November 15, 2021
• Primary Completion: November 15, 2021
• Study Completion: November 15, 2021
• Last Updated: February 1, 2022

Record last verified: 2022-01