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

  • STATUS
    Recruiting
  • End date
    Jan 1, 2025
  • participants needed
    100
  • sponsor
    Wroclaw Medical University
Updated on 24 January 2021
fluorouracil
brimonidine tartrate ophthalmic solution
primary open angle glaucoma
gonioscopy

Summary

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

Details
Condition Glaucoma, Pigmentary glaucoma, Open Angle Glaucoma
Treatment 5-fluorouracil, Transconjunctival needling, Transconjunctival revision
Clinical Study IdentifierNCT03904381
SponsorWroclaw Medical University
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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
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