Clinical Trials Logo
  1. Home
  2. Glaucoma
  3. NCT03151577
  4. Details
NCT03151577 Clinical Trial

Longitudinal Study on Glaucoma Surgery Using XEN® Gel Stent

Glaucoma Clinical Trial

Official title:
Longitudinal Study on Glaucoma Surgery Using XEN® Gel Stent

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03151577
Other study ID # 2016-02077
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 1, 2015
Est. completion date May 31, 2023

Study information
Verified date May 2022
Source Swiss Vision Network
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 150
Est. completion date May 31, 2023
Est. primary completion date January 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• XEN® Gel Stent implantation
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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Swiss Vision Network

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Number of needlings Number of needlings performed during the follow-up after surgery 2 years
Secondary Number of antiglaucomatous medications Change in number of antiglaucomatous medications before and after the surgery. Day 0 (=Baseline=before surgery), after surgery on day 1, day 3, week 1, month 1, month 3, month 6, year 1, year 2
See also
  Status Clinical Trial Phase
Recruiting NCT06000865 - Glaucoma Rehabilitation With Action viDeo Games and Exercise - GRADE N/A
Recruiting NCT06278597 - Automatic Evaluation of the Anterior Chamber Angle Width by a New Non-contact Optical Device N/A
Active, not recruiting NCT04271709 - Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT) N/A
Recruiting NCT03274024 - The Asia Primary Tube Versus Trab (TVT) Study N/A
Completed NCT04552964 - Assessment of the Impact of an add-on and Its Smartphone Application on the Daily Management of Glaucoma N/A
Recruiting NCT01957267 - Functional and Structural Imaging for Glaucoma
Active, not recruiting NCT04624698 - iStent Inject New Enrollment Post-Approval Study N/A
Completed NCT04020705 - The Efficacy of Citicoline in Eyedrops (OMK1) in Reducing the Progression of Glaucoma N/A
Completed NCT03150160 - Additive Effect of Twice-daily Brinzolamide 1%/Brimonidine 0.2%Combination as an Adjunctive Therapy to Travoprost in Patients With Normal Tension Glaucoma Phase 4
Not yet recruiting NCT05581498 - Glaucoma Exercise as Medicine Study (GEMS). N/A
Recruiting NCT02921568 - Side-by-Side Comparison of P200TE and Spectral OCT/SLO on Diseased Eyes N/A
Active, not recruiting NCT02901730 - Clinical Study of LPI With Different Laser Wavelengths N/A
Completed NCT02955849 - A Trial of China Laser and Surgery Study Glaucoma in Rural China Early Phase 1
Recruiting NCT02471105 - Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml Phase 4
Recruiting NCT02554214 - Pilot Clinical Trial on a New Adjustable Glaucoma Drainage Device N/A
Active, not recruiting NCT02390284 - Stop Retinal Ganglion Cell Dysfunction Study Phase 3
Completed NCT02390245 - Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study N/A
Completed NCT02246764 - Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension Phase 3
Completed NCT02520674 - Glaucoma Screening With Smartphone Ophthalmology N/A
Completed NCT02628223 - 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma N/A