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 Institute150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Glaucoma

Interventions

XEN implantationPROCEDURE

The surgeon used the ab interno or ab externo technique for XEN implantation. In cases where only the lower quadrants were accessible, the ab externo access was the technique of choice. All treatments were performed with 40 micrograms of mitomycin C, which was injected under the conjunctiva at least 6mm from the corneal limbus in the projection of the future filtering bleb. If a clinically significant cataract was also observed in a phakic patient, the patient qualified for a combined procedure with phacoemulsification and implantation of an artificial intraocular lens.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Military Institute of Medicine - National Research Institute

Warsaw, Poland

Outcomes

Primary Outcomes

IOP

Intraocular Pressure

Time frame: through study completion, an average of 5 years

BCVA

The change of best- corrected visual acuity

Time frame: through study completion, an average of 5 years

Visual Field

Visual Field of the mean defect

Time frame: through study completion, an average of 5 years

Secondary Outcomes

Medications

Median number of patients who took medications before surgery and up until the end of the study

Time frame: through study completion, an average of 5 years

Data from ClinicalTrials.gov

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