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Completed

NCT Number: NCT07350200

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

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

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Military Institute of Medicine - National Research Institute

Warsaw, 04-141, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XEN implantation

Procedure

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.

Primary outcomes

  1. IOP

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

    Intraocular Pressure

  2. BCVA

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

    The change of best- corrected visual acuity

  3. Visual Field

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

    Visual Field of the mean defect

Secondary outcomes

  1. Medications

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

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

Sponsors and collaborators

Lead sponsor

Military Institute od Medicine National Research Institute

Other

Registry information

Important dates

Study start
2014
Primary completion
2025
Study completion
2025
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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