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

Overview

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

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: September 30, 2022

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

• Device: Cadence 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

Arms, Groups and Cohorts

• Experimental: Cadence
  • Cadence procedure

Clinical Trial Outcome Measures

Primary Measures

• Assessment of AEs
  • Time Frame: 12 months
  • comparison of intra-operative and post-operative adverse events observed to events reported in published literature,

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 22 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • New World Medical, Inc.
• Provider of Information About this Clinical Study
  • Sponsor