Longitudinal Study on Glaucoma Surgery Using XEN® Gel Stent

NCT03151577 — Not applicable, Unknown, 150 participants, Swiss Vision Network

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Registry	NCT03151577
Status	Unknown
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	150 (Actual)
Sponsor	Swiss Vision Network (Other)
Conditions	Glaucoma, Glaucoma, Open-Angle, Glaucoma, Angle-Closure, Glaucoma, Primary Open Angle
Interventions	XEN® Gel Stent implantation (Procedure)
Dates	start 2015-01-01, primary completion 2019-01-31, completion 2023-05-31 (estimated), first posted 2017-05-12, last updated 2022-05-05

-Summary

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

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+Detailed description

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

Follow-up period is 2 years.

+Arms and interventions

Arm	Type	Interventions	Description
Evolution of IOP after XEN® Gel Stent implantation	Other	Procedure: XEN® Gel Stent implantation	To study the efficacy of the XEN® Gel Stent in lowering the IOP.

XEN® Gel Stent implantation (Procedure), also known as XEN® Gel Stent, Aquesys: 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.

+Outcome measures

Primary outcomes

Intraocular pressure [Day 0 (=Baseline=before surgery), after surgery on day 1, day 3, week 1, month 1, month 3, month 6, year 1, year 2]: Change in IOP before and after XEN® Gel Stent implantation

Secondary outcomes

Number of needlings [2 years]: Number of needlings performed during the follow-up after surgery
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]: Change in number of antiglaucomatous medications before and after the surgery.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

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

Exclusion Criteria:

* 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

+Publications

Results publication: 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
Results publication: 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

+Funding

NIH grants: 2016

My Notes

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