Trial | NCT03904381  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Active, not recruiting

  • Intervention/Treatment

    5-fluorouracil ...

  • Study Participants

    100
To evaluate the efficacy of postoperative management with 5-fluorouracil injections after XEN Gel Stent implantation.
Study Started
Jan 01
2016
Primary Completion
Jan 01
2024
Anticipated
Study Completion
Jan 01
2025
Anticipated
Last Update
Mar 29
2022

Drug 5-fluorouracil

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

Procedure Transconjunctival needling

Transconjunctival needling was administered according to predetermined criteria.

Procedure Transconjunctival revision

Transconjunctival revision was administered according to predetermined criteria.

stand-alone procedure of XEN implantation in phakic eyes Active Comparator

stand-alone procedure of XEN implantation in pseudophakic eyes Active Comparator

XEN implantation combined with cataract extraction Active Comparator

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
No Results Posted