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

NCT03904381 | Unknown Phase 4

• 1 other identifier: STM.C240.17.037
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy of postoperative management with 5-fluorouracil injections after XEN Gel Stent implantation.

Conditions

Open-angle Glaucoma

Outcome Measures

Primary Outcomes (1)

• Unqualified success

  Unqualified success of glaucoma treatment, defined as a postoperative IOP \<18 mmHg and \>20% reduction compared with the baseline value, achieved without use of any antiglaucoma medication and with no detected glaucoma progression as assessed at the final follow-up visit.

  5 years

Secondary Outcomes (3)

• Qualified success score A

  5 years

• Qualified success score B

  5 years

• Qualified success score C

  5 years

Other Outcomes (9)

• Glaucoma Progression

  5 years

• Change in thickness of the retinal nerve fiber layer (RNFL)

  5 years

• Change in thickness of ganglion cell complex (GCC)

  5 years

Study Arms (3)

stand-alone procedure of XEN implantation in phakic eyes

ACTIVE COMPARATOR

Drug: 5-fluorouracil; Procedure: Transconjunctival needling; Procedure: Transconjunctival revision

stand-alone procedure of XEN implantation in pseudophakic eyes

ACTIVE COMPARATOR

Drug: 5-fluorouracil; Procedure: Transconjunctival needling; Procedure: Transconjunctival revision

XEN implantation combined with cataract extraction

ACTIVE COMPARATOR

Drug: 5-fluorouracil; Procedure: Transconjunctival needling; Procedure: Transconjunctival revision

Interventions

5-fluorouracil DRUG

5-fluorouracil subconjunctival injections were a first-choice therapy for bleb failure and were administered according to predetermined criteria.

XEN implantation combined with cataract extraction; stand-alone procedure of XEN implantation in phakic eyes; stand-alone procedure of XEN implantation in pseudophakic eyes

Transconjunctival needling PROCEDURE

Transconjunctival needling was administered according to predetermined criteria.

XEN implantation combined with cataract extraction; stand-alone procedure of XEN implantation in phakic eyes; stand-alone procedure of XEN implantation in pseudophakic eyes

Transconjunctival revision PROCEDURE

Transconjunctival revision was administered according to predetermined criteria.

XEN implantation combined with cataract extraction; stand-alone procedure of XEN implantation in phakic eyes; stand-alone procedure of XEN implantation in pseudophakic eyes

Eligibility Criteria

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

You may qualify if:

• diagnosis of primary open angle glaucoma
• trabecular meshwork visible in gonioscopy
• medicated IOP of ≥ 15 mmHg and ≤ 35 mmHg
• taking 1 to 5 IOP-lowering medications
• area of healthy, free and mobile conjunctiva in the target quadrant (superior-nasal)
• signed inform consent

You may not qualify if:

• angle closure glaucoma
• secondary open angle glaucoma
• previous glaucoma shunt/valve in the target quadrant
• presence of conjunctival scarring, prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target quadrant
• active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis)
• active iris neovascularization or neovascularization of the iris within 6 months of the surgical date
• anterior chamber intraocular lens
• presence of intraocular silicone oil
• vitreous present in the anterior chamber
• impaired episcleral venous drainage (e.g., Sturge-Weber or nanophthalmos or other evidence of elevated venous pressure)
• known or suspected allergy or sensitivity to drugs required for the surgical procedure or any of the device components (e.g., porcine products or glutaraldehyde)
• history of dermatologic keloid formation
• previous photorefractive keratectomy

Sponsors & Collaborators

• Wroclaw Medical University: lead
• Wrocław University of Science and Technology: collaborator

Study Sites (1)

Department of Ophthalmology

Wroclaw, 54-622, Poland

Location

Related Publications (2)

• Budenz DL, Rhee P, Feuer WJ, McSoley J, Johnson CA, Anderson DR. Comparison of glaucomatous visual field defects using standard full threshold and Swedish interactive threshold algorithms. Arch Ophthalmol. 2002 Sep;120(9):1136-41. doi: 10.1001/archopht.120.9.1136.

  PMID: 12215086 BACKGROUND

• Susanna R Jr, Vessani RM. Staging glaucoma patient: why and how? Open Ophthalmol J. 2009 Sep 17;3:59-64. doi: 10.2174/1874364100903020059.

  PMID: 19834563 BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Fluorouracil

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Marta Misiuk-Hojło, Professor

  Medical University of Wrocław

  STUDY CHAIR

• Ewa Wałek

  Medical University of Wrocław

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 5, 2019
• Study Start: January 1, 2016
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2025
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)