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

NCT ID: NCT05131087

Last Updated: 2023-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-08
• Study Completion Date: 2023-07-05

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

Conditions

Glaucoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cadence

Cadence procedure

Group Type: EXPERIMENTAL

Cadence implant

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New World Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Sun, PhD

Role: STUDY_DIRECTOR

New World Medical, Inc.

Locations

Clinica Laser y Ultrasonido Ocular de Puebla

Puebla City, , Mexico

Countries

Mexico

Other Identifiers

DF8-CL-20-02

Identifier Type: -

Identifier Source: org_study_id