NCT04454138

Brief Summary

The Xen-45 gelatin microstent is a novel, bleb-forming microinvasive glaucoma surgery (MIGS). Despite demonstrating similar efficacy and safety to trabeculectomy (traditional surgery), the Xen-45 gelatin microstent continues to suffer from occasional surgical failure due to fibrosis of the filtering bleb, and obstruction of the stent. During surgery, placement in a surgery known as supra-tenon's space is believed to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency. Despite the theoretical merits, long-term data of outcomes after targeted supra-tenon's placement is needed to fully assess its potential in improving Xen-45 microstent outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 25, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 1, 2020

Completed
1 month until next milestone

Results Posted

Study results publicly available

August 5, 2020

Completed
Last Updated

August 14, 2020

Status Verified

August 1, 2020

Enrollment Period

10 months

First QC Date

June 23, 2020

Results QC Date

July 3, 2020

Last Update Submit

August 4, 2020

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (6)

  • Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement.

    Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) on no medications

    Post op year 1

  • Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 2.

    Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) +/- Medications

    Post op Year 1

  • Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 3.

    Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤17 (mmHg) on no medications

    Post op year 1

  • Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 4.

    Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤17 (mmHg) +/- medication

    Post op Year 1

  • Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 5.

    Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤21 (mmHg) on no medications

    Post op Year 1

  • Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 6.

    Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) +/- medications

    Post op year 1

Secondary Outcomes (2)

  • Number of Participants With Postoperative Complications Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Non-targeted Placement.

    Post op year 1

  • Number of Participants With Postoperative Interventions Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Non-targeted Placement.

    Post op year 1

Study Arms (2)

Targeted supratenon's placement of XEN 45

Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency.

Device: XEN-45 gelatin microstent

Non-targeted placement of XEN 45

Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement.

Device: XEN-45 gelatin microstent

Interventions

XEN-45 gelatin microstentDEVICE

Placement either in the subconjunctival space or supratenon's area

Non-targeted placement of XEN 45Targeted supratenon's placement of XEN 45

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 30-90 with primary or pigmentary/pseudoexfolliative open angle, primary closed angle, or combined mechanism glaucoma with IOP of 18-40 mmHg on maximum tolerated medical therapy who received a gelatin stent with MMC at Prism Eye Institute from June 2012 to August 2019.

You may qualify if:

  • Patients aged 30-90 with primary or pigmentary/pseudoexfolliative open angle, primary closed angle, or combined mechanism glaucoma with IOP of 18-40 mmHg on maximum tolerated medical therapy who received a gelatin stent with MMC at Prism Eye Institute from June 2012 to August 2019.

You may not qualify if:

  • Other forms of glaucoma
  • Prior incisional glaucoma surgery
  • CPC
  • Prior corneal graft (PKP, DALK, DSAEK, DMEK).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prism Eye Institute

Oakville, Ontario, L6H 0J8, Canada

Location

Related Publications (4)

  • Conlon R, Saheb H, Ahmed II. Glaucoma treatment trends: a review. Can J Ophthalmol. 2017 Feb;52(1):114-124. doi: 10.1016/j.jcjo.2016.07.013. Epub 2016 Nov 17.

    PMID: 28237137BACKGROUND

  • Schlenker MB, Gulamhusein H, Conrad-Hengerer I, Somers A, Lenzhofer M, Stalmans I, Reitsamer H, Hengerer FH, Ahmed IIK. Efficacy, Safety, and Risk Factors for Failure of Standalone Ab Interno Gelatin Microstent Implantation versus Standalone Trabeculectomy. Ophthalmology. 2017 Nov;124(11):1579-1588. doi: 10.1016/j.ophtha.2017.05.004. Epub 2017 Jun 7.

    PMID: 28601250BACKGROUND

  • Fea AM, Spinetta R, Cannizzo PML, Consolandi G, Lavia C, Aragno V, Germinetti F, Rolle T. Evaluation of Bleb Morphology and Reduction in IOP and Glaucoma Medication following Implantation of a Novel Gel Stent. J Ophthalmol. 2017;2017:9364910. doi: 10.1155/2017/9364910. Epub 2017 Jun 20.

    PMID: 28751986BACKGROUND

  • Sng CC, Wang J, Hau S, Htoon HM, Barton K. XEN-45 collagen implant for the treatment of uveitic glaucoma. Clin Exp Ophthalmol. 2018 May;46(4):339-345. doi: 10.1111/ceo.13087. Epub 2017 Nov 29.

    PMID: 29053204BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Results Point of Contact

Title
Ronaldo Santiago
Organization
Prism Eye Institute
ronaldo.santiago@prismeye.ca
905-456-3937

Study Officials

  • Iqbal Ike Ahmed, MD

    Prism Eye Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 23, 2020

First Posted

July 1, 2020

Study Start

June 25, 2019

Primary Completion

April 20, 2020

Study Completion

April 20, 2020

Last Updated

August 14, 2020

Results First Posted

August 5, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)