XEN Glaucoma Implant for the Management of Operated Uncontrolled Glaucoma: Results and Complications During a Long-Term Follow-Up

Military Institute od Medicine National Research Institute

Status: Completed

Conditions: Glaucoma

Treatments: Procedure: XEN implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT07350200

5/WIM/2021

Details and patient eligibility

About

XEN Glaucoma Implant for the Management of Operated Uncontrolled Glaucoma: Results and Complications During a Long-Term Follow-Up

Full description

Purpose of the study is to analyze the surgical and refractive outcomes of XEN glaucoma implant, a minimally invasive surgical device for the treatment of operated uncontrolled glaucoma. Intraocular pressure change, best corrected visual acuity, change in glaucoma medications, frequency of slit lamp revision procedures, and frequency of secondary glaucoma surgeries were the primary outcomes.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• presence of OUG, defined as prior treatment with surgical or cyclodestructive procedures
• failure to achieve target IOP with maximally tolerated topical IOP-lowering treatment or intolerance to drugs
• both primary and secondary open- and closed-angle glaucoma cases
• presence of healthy mobile conjunctiva in at least one quadrant and bestcorrected visual acuity

Exclusion criteria

• presence of clinically significant inflammation or infection within 30 days before surgery, history of corneal refractive surgery, corneal deposits or haze preventing intraoperative viewing of the anterior chamber, presence of an anterior chamber lens, advanced age-related macular degeneration (AMD), known or suspected allergy or sensitivity to porcine products or glutaraldehyde, pregnant or nursing women, and lack of consent to participate in the study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

XEN Glaucoma Implant for the Management of Operated Uncontrolled Glaucoma

Experimental group

Description:

Group of patients, who underwent XEN implantation and had a history of previous unsuccessful antiglaucoma procedures, and who were subject to surgeries performed by the same experienced surgeon.

Treatment:

Procedure: XEN implantation