A First-In-Human Clinical Trial to Evaluate the Safety, Effectiveness and Surgical Characteristics of CADENCE in Patients With Refractory Glaucoma

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05131087

Enrollment

Registered

2021-11-23

Start date

2020-10-08

Completion date

2023-07-05

Last updated

2023-10-13

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

Conditions

Glaucoma

Keywords

glaucoma

Brief summary

To evaluate safety, effectiveness, and the surgical performance of CADENCE in patients with refractory glaucoma.

Detailed description

CADENCE a single use implantable glaucoma drainage device used for the surgical treatment of refractory glaucoma. The device is implanted in the eye using an ab-externo approach

Interventions

DEVICECadence implant

CADENCE Glaucoma Drainage Device System is a single use implantable glaucoma drainage device used for the surgical treatment of refractory glaucoma. The device is implanted in the eye using an ab-externo approach

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Open Label

Eligibility

Sex/Gender

ALL

Age

22 Years to 80 Years

Healthy volunteers

Inclusion criteria

* 22-80 years of age. * moderate to severe refractory glaucoma * Able to consent

Exclusion criteria

* Women of child-bearing potential * Intraocular surgery or laser within the last 3 months * Ocular infection or inflammation within the last 6 months or currently active * Current use of anti-coagulant therapy * History of bleeding disorder or coagulopathies * Subject plans to undergo any ocular surgery (including cataract surgery) during the study period * History of corneal transplantation * History of ICE Syndrome or epithelial ingrowth/downgrowth * History of congenital glaucoma * Elevated episcleral venous pressure -. Persistent angle closure- * Previous glaucoma filtration surgery- -Presence of conjunctival scarring - * neovascular glaucoma * AC lens or scleral sutured IOL * Aphakia * inability to DC contact lenses * Presence of intraocular silicone oil * Vitreous in AC

Design outcomes

Primary

Measure	Time frame	Description
Assessment of AEs	12 months	comparison of intra-operative and post-operative adverse events observed to events reported in published literature,

Secondary

Measure	Time frame	Description
Surgical Experience Evaluation	12 months	An evaluation of the surgical experience using feedback questionnaire to describe specific note of performance characteristics of each implant.
Change in IOP	12 months	Change in IOP from Screening to M12
Change in IOP Lowering Medications	12 months	Change in IOP lowering medications from Screening to M12

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026