Efficacy and Safety of XEN® Gel Stent and Post-operative Management in Patients With Open Angle Glaucoma
- Conditions
- Open-angle Glaucoma
- Interventions
- Registration Number
- NCT03904381
- Lead Sponsor
- Wroclaw Medical University
- Brief Summary
To evaluate the efficacy of postoperative management with 5-fluorouracil injections after XEN Gel Stent implantation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description XEN implantation combined with cataract extraction Transconjunctival revision - stand-alone procedure of XEN implantation in phakic eyes Transconjunctival revision - stand-alone procedure of XEN implantation in phakic eyes Transconjunctival needling - stand-alone procedure of XEN implantation in pseudophakic eyes Transconjunctival revision - stand-alone procedure of XEN implantation in pseudophakic eyes Transconjunctival needling - XEN implantation combined with cataract extraction Transconjunctival needling - stand-alone procedure of XEN implantation in phakic eyes 5-fluorouracil - stand-alone procedure of XEN implantation in pseudophakic eyes 5-fluorouracil - XEN implantation combined with cataract extraction 5-fluorouracil -
- Primary Outcome Measures
Name Time Method Unqualified success 5 years 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.
- Secondary Outcome Measures
Name Time Method Qualified success score B 5 years Qualified success of glaucoma treatment, defined as a postoperative IOP \< 18 mmHg and \>20% reduction compared with the baseline value, achieved with or without use of antiglaucoma medication and with no detected glaucoma progression as assessed at the final follow-up visit.
Qualified success score C 5 years Qualified success of glaucoma treatment, defined as a postoperative IOP ≤15 mmHg and \>40% reduction compared with the baseline value, achieved with or without use of antiglaucoma medication and with no detected glaucoma progression as assessed at the final follow-up visit.
Qualified success score A 5 years Qualified success of glaucoma treatment, defined as a postoperative IOP \<21 mmHg and \>20% reduction compared with the baseline value, achieved with or without use of antiglaucoma medication and with no detected glaucoma progression as assessed at the final follow-up visit.
Trial Locations
- Locations (1)
Department of Ophthalmology
🇵🇱Wrocław, Poland