Xen Gel Stent: efficacy, safety and filtering bleb analysis at one year

Xen Gel Stent implantation in patients affected by primary open angle glaucoma: safety, filtering bleb analysis, intraocular pressure and glaucoma medication use variations within one year

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18170221

Enrollment

Registered

2017-03-09

Start date

2014-06-12

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary open angle glaucoma, cataract Eye Diseases

Interventions

Patients underwent implantation of the Xen Gel Stent (AqueSys Inc, Aliso Viejo, CA, USA), a minimally invasive glaucoma surgery device that creates a subconjunctival filtering bleb through an ab inter

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with a diagnosis of POAG with uncontrolled IOP (defined as =18 mm Hg and =33 mm Hg on between one and four anti-glaucoma medications) 2. A healthy and mobile superior bulbar conjunctiva 3. Age 20-70

Exclusion criteria

Exclusion criteria: 1. Previous corneal and glaucoma surgery 2. Diagnosis of glaucoma other than POAG 3. Corneal opacities 4. Ocular diseases other than glaucoma

Design outcomes

Primary

Measure	Time frame
1. Intraocular pressure, measured using Goldmann applanation tonometry (GAT) at baseline, 1 day, 7 days, 1, 3, 6, 9 and 12 months 2. Visual acuity, measured with the standard ETDRS charts at baseline, 1 day, 7 days, 1, 3, 6, 9 and 12 months 3. Incidence of adverse events, measured using a pre-built questionnaire at baseline, 1 day, 7 days, 1, 3, 6, 9 and 12 months 4. Visual field, measured using Humphrey 24-2 at baseline and 12 months 5. Endothelial cell count, measured using Konan Cell Check XL at 1, 3, 6 and 12 months	—

Measure

Time frame

1. Intraocular pressure, measured using Goldmann applanation tonometry (GAT) at baseline, 1 day, 7 days, 1, 3, 6, 9 and 12 months 2. Visual acuity, measured with the standard ETDRS charts at baseline, 1 day, 7 days, 1, 3, 6, 9 and 12 months 3. Incidence of adverse events, measured using a pre-built questionnaire at baseline, 1 day, 7 days, 1, 3, 6, 9 and 12 months 4. Visual field, measured using Humphrey 24-2 at baseline and 12 months 5. Endothelial cell count, measured using Konan Cell Check XL at 1, 3, 6 and 12 months

—

Secondary

Measure	Time frame
Bleb morphology, assessed using AS OCT (RTVue-100, Optovue) and in vivo confocal microscopy (HRTII/Rostock Cornea Module) at baseline, 1, 3, 6 and 12 months	—

Countries

Italy

Contacts

Public ContactAntonio Fea

antoniomfea@gmail.com+39 (0)115 661 566

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026