Real World Evidence of Xen45 Gel Implant in Pseudoexfoliation Glaucoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The Xen implant is an ab interno device that has been shown to be effective in reducing intraocular pressure in several types of glaucoma, although the evidence in pseudoexfoliative glaucoma is limited. The present retrospective observational study aims to increase knowledge about the long-term effectiveness and safety of the implant in pseudoexfoliative glaucoma. Researchers will compare the results with data from patients with open-angle glaucoma.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of the XEN Implant in Moderate Primary Open Angle Glaucoma (POAG) Participants

NCT02006693

Primary Open Angle Glaucoma

COMPLETED PHASE4

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

NCT03904381

Open-angle Glaucoma

UNKNOWN PHASE4

XEN Glaucoma Gel Stent Versus Trabeculectomy

NCT05439161

Primary Open Angle Glaucoma Pseudoexfoliation Glaucoma Pigmentary Dispersion Glaucoma

RECRUITING NA

Efficacy and Safety of XEN63 Gel Implant

NCT06844240

Glaucoma

ENROLLING_BY_INVITATION

Analysis of Conjunctival Changes as Indicators for Ab-interno Gelatin Microstent Implantation Surgery Outcomes

NCT04727411

Glaucoma Glaucoma Open-Angle Primary

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pseudoexfoliation Syndrome Pseudoexfoliation Glaucoma in Both Eyes Open Angle Glaucoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pseudoexfoliation glaucoma

Xen Gel Stent implantation

Intervention Type DEVICE

Consecutive patients who underwent either stand-alone Xen stent insertion with MMC(mitomycin C) or combined phacoemulsification between 2018 and 2022

Open-angle glaucoma

Xen Gel Stent implantation

Intervention Type DEVICE

Consecutive patients who underwent either stand-alone Xen stent insertion with MMC(mitomycin C) or combined phacoemulsification between 2018 and 2022

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Xen Gel Stent implantation

Consecutive patients who underwent either stand-alone Xen stent insertion with MMC(mitomycin C) or combined phacoemulsification between 2018 and 2022

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Data will be collected for all patients with pseudoexfoliation glaucoma (PXFG), ocular hypertension (OHT) and pseudoexfoliation syndrome, POAG and other secondary open angle glaucoma (OAG) diagnosed, who underwent surgery from 2018 to 2022.

Patients should be candidates for filtering glaucoma surgery for the following indications:

* uncontrolled intraocular pressure (IOP)
* intolerance or non-adherence to topical treatment
* glaucoma progression despite topical therapy
* surgical cataract patients undergoing phacoemulsification, who were treated with two or more hypotensive drugs and wished to withdraw the medication due to side effects and/or discomfort of the treatment.

Refractory glaucoma and eyes with previous filtering surgery, previous laser treatments or micropulse transscleral cyclophotocoagulation will be also included.