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Efficacy and Safety of XEN® Gel Stent and Post-operative Management in Patients With Open Angle Glaucoma

NCT03904381 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-03-29

No results posted yet for this study

Summary

To evaluate the efficacy of postoperative management with 5-fluorouracil injections after XEN Gel Stent implantation.

Conditions

  • Open-angle Glaucoma

Interventions

DRUG

5-fluorouracil

5-fluorouracil subconjunctival injections were a first-choice therapy for bleb failure and were administered according to predetermined criteria.

PROCEDURE

Transconjunctival needling

Transconjunctival needling was administered according to predetermined criteria.

PROCEDURE

Transconjunctival revision

Transconjunctival revision was administered according to predetermined criteria.

Sponsors & Collaborators

  • Wrocław University of Science and Technology

    collaborator OTHER

  • Wroclaw Medical University

    lead OTHER

Principal Investigators

  • Marta Misiuk-Hojło, Professor · Medical University of Wrocław

  • Ewa Wałek · Medical University of Wrocław

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-01
Primary Completion
2024-01-01
Completion
2025-01-01

Countries

  • Poland

Study Locations

More Related Trials

Entities

Drugs

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 NCT03904381 on ClinicalTrials.gov