Clinical trial NCT03904381: Efficacy and Safety of XEN® Gel Stent and Post-operative Management in Patients With Open Angle Glaucoma
Official title: Efficacy and Safety of XEN® Gel Stent and Post-operative Management in Patients With Open Angle Glaucoma Compared to Classic Glaucoma Surgeries (Trabeculectomy and Sclerectomy) as Well as Other Minilally Invasive Glaucoma Surgery (MIGS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Open-angle Glaucoma
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
Collaborators: name: Wrocław University of Science and Technology
First posted: 2019-04-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Unqualified success
timeFrame: 5 years
Secondary outcomes:
measure: Qualified success score A
timeFrame: 5 years
measure: Qualified success score B
timeFrame: 5 years
measure: Qualified success score C
timeFrame: 5 years
Other outcomes:
measure: Glaucoma Progression
timeFrame: 5 years
measure: Change in thickness of the retinal nerve fiber layer (RNFL)
timeFrame: 5 years
measure: Change in thickness of ganglion cell complex (GCC)
timeFrame: 5 years
measure: Short term changes in IOP after surgery
timeFrame: 5 years
measure: Refractive error
timeFrame: 5 years
measure: Best-corrected visual acuity
timeFrame: 5 years
measure: Visual field (VF)
timeFrame: 5 years
measure: Disc damage likelihood scale (DDLS)
timeFrame: 5 years
measure: Peripapillar and macular vessels density
timeFrame: 5 years
Locations:
city: Wrocław
country: Poland
facility: Department of Ophthalmology
Study officials:
affiliation: Medical University of Wrocław
name: Marta Misiuk-Hojło, Professor
role: STUDY_CHAIR
affiliation: Medical University of Wrocław
name: Ewa Wałek
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Susanna R Jr, Vessani RM. Staging glaucoma patient: why and how? Open Ophthalmol J. 2009 Sep 17;3:59-64. doi: 10.2174/1874364100903020059.