Longitudinal Study on Glaucoma Surgery Using XEN® Gel Stent

NCT03151577 | Unknown

• 1 other identifier: 2016-02077
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the safety and efficacy of the XEN® Gel Stent in mild to moderate glaucoma patients undergoing glaucoma surgery.

Conditions

Glaucoma; Glaucoma, Open-Angle; Glaucoma, Angle-Closure; Glaucoma, Primary Open Angle

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure

  Change in IOP before and after XEN® Gel Stent implantation

  Day 0 (=Baseline=before surgery), after surgery on day 1, day 3, week 1, month 1, month 3, month 6, year 1, year 2

Secondary Outcomes (2)

• Number of needlings

  2 years

• Number of antiglaucomatous medications

  Day 0 (=Baseline=before surgery), after surgery on day 1, day 3, week 1, month 1, month 3, month 6, year 1, year 2

Study Arms (1)

Evolution of IOP after XEN® Gel Stent implantation

OTHER

To study the efficacy of the XEN® Gel Stent in lowering the IOP.

Procedure: XEN® Gel Stent implantation

Interventions

XEN® Gel Stent implantation PROCEDURE

Minimally invasive glaucoma surgery (MIGS) which consists of implanting a XEN® Gel Stent in the irido-corneal angle of the eye to drain the aqueous humour in the sub-conjunctival space to lower the IOP.

Also known as: XEN® Gel Stent, Aquesys

Evolution of IOP after XEN® Gel Stent implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild to moderate glaucoma patients
• Have given written informed consent
• Aged 18 years or older of either sex

You may not qualify if:

• Patients not able to understand the character of the study
• Participation in other clinical research within the last 4 weeks
• Patients with end-stage glaucoma
• Patients with glaucoma surgery done before

Sponsors & Collaborators

• Swiss Vision Network: lead

Related Publications (2)

• Gillmann K, Bravetti GE, Rao HL, Mermoud A, Mansouri K. Bilateral XEN Stent Implantation: A Long-term Prospective Study of the Difference in Outcomes Between First-operated and Fellow Eyes. J Glaucoma. 2020 Jul;29(7):536-541. doi: 10.1097/IJG.0000000000001520.

  PMID: 32341321 DERIVED

• Mansouri K, Gillmann K, Rao HL, Guidotti J, Mermoud A. Prospective Evaluation of XEN Gel Implant in Eyes With Pseudoexfoliative Glaucoma. J Glaucoma. 2018 Oct;27(10):869-873. doi: 10.1097/IJG.0000000000001045.

  PMID: 30095603 DERIVED

MeSH Terms

Conditions

Glaucoma; Glaucoma, Open-Angle; Glaucoma, Angle-Closure

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MPH

Model Details: Intraocular pressure, adverse events, complications, number of medications in mild to moderate glaucoma patients who underwent XEN® Gel Stent implantation were recorded. Data were collected in a 2 years follow-up.

Study Record Dates

• First Submitted: April 28, 2017
• First Posted: May 12, 2017
• Study Start: January 1, 2015
• Primary Completion: January 31, 2019
• Study Completion: May 31, 2023
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share