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

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

Official Title
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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)

Conditions
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Open-angle Glaucoma

Intervention / Treatment
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* Drug: 5-fluorouracil
* Procedure: Transconjunctival needling
* Procedure: Transconjunctival revision


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: stand-alone procedure of XEN implantation in phakic eyes<br> | Drug: 5-fluorouracil<br>* 5-fluorouracil subconjunctival injections were a first-choice therapy for bleb failure and were administered according to predetermined criteria.<br>Procedure: Transconjunctival needling<br>* Transconjunctival needling was administered according to predetermined criteria.<br>Procedure: Transconjunctival revision<br>* Transconjunctival revision was administered according to predetermined criteria.<br>|
| Active Comparator: stand-alone procedure of XEN implantation in pseudophakic eyes<br> | Drug: 5-fluorouracil<br>* 5-fluorouracil subconjunctival injections were a first-choice therapy for bleb failure and were administered according to predetermined criteria.<br>Procedure: Transconjunctival needling<br>* Transconjunctival needling was administered according to predetermined criteria.<br>Procedure: Transconjunctival revision<br>* Transconjunctival revision was administered according to predetermined criteria.<br>|
| Active Comparator: XEN implantation combined with cataract extraction<br> | Drug: 5-fluorouracil<br>* 5-fluorouracil subconjunctival injections were a first-choice therapy for bleb failure and were administered according to predetermined criteria.<br>Procedure: Transconjunctival needling<br>* Transconjunctival needling was administered according to predetermined criteria.<br>Procedure: Transconjunctival revision<br>* Transconjunctival revision was administered according to predetermined criteria.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualified success score A | 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. | 5 years | 
| Qualified success score B | 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. | 5 years | 
| Qualified success score C | 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. | 5 years |