N/A Completed N=65 Treatment

AqueSys XEN 45 Glaucoma Implant in Refractory Glaucoma

Glaucoma · Glaucoma, Open Angle

Source: ClinicalTrials.gov NCT02036541 ↗

Enrolled (actual)

Serious AEs

13.9%

Results posted

Jun 2017

Primary outcomePrimary: Proportion of Subjects Achieving a 20% or Greater Reduction in IOP From Baseline on the Same or Less Number of Medications — 46 Participants

Summary

To establish the safety and performance of the AqueSys XEN 45 Glaucoma Implant in eyes with refractory glaucoma.

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Subjects Achieving a 20% or Greater Reduction in IOP From Baseline on the Same or Less Number of Medications	46	—
PRIMARY Mean Change in IOP From Baseline	6.2	—

Eligibility Criteria

Inclusion Criteria

Diagnosis of Refractory Glaucoma
Maximally-tolerated medicated IOP at two preoperative visits of ≥20 mmHg and ≤35 mmHg
Visual field mean deviation score of -3 dB or worse
Shaffer Angle Grade ≥ 3
Area of free, healthy and mobile conjunctiva in the targeted quadrant

Exclusion Criteria

Active Neovascular Glaucoma
Previous glaucoma shunt/valve in the targeted quadrant
History of corneal surgery, opacities or disease/pathology
Anticipated need for ocular surgery
Non-study eye with BCVA of 20/200 or worse

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02036541). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.