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

New World Medical

Status: Completed

Conditions: Glaucoma

Treatments: Device: Cadence implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT05131087

DF8-CL-20-02

Details and patient eligibility

About

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

Full 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

Enrollment: 30 patients

Sex: All

Ages: 22 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Cadence

Experimental group

Description:

Cadence procedure

Treatment:

Device: Cadence implant