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

New World Medical, Inc.30 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glaucoma

Interventions

Cadence implantDEVICE

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

Eligibility

Sex: ALLMin age: 22 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Clinica Laser y Ultrasonido Ocular de Puebla

Puebla City, Mexico

Outcomes

Primary Outcomes

Assessment of AEs

comparison of intra-operative and post-operative adverse events observed to events reported in published literature,

Time frame: 12 months

Secondary Outcomes

Surgical Experience Evaluation

An evaluation of the surgical experience using feedback questionnaire to describe specific note of performance characteristics of each implant.

Time frame: 12 months

Change in IOP

Change in IOP from Screening to M12

Time frame: 12 months

Change in IOP Lowering Medications

Change in IOP lowering medications from Screening to M12

Time frame: 12 months

Data from ClinicalTrials.gov

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