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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05131087
• Other study ID #: DF8-CL-20-02
• Status: Completed
• Phase: N/A
• Start date: October 8, 2020
• Est. completion date: July 5, 2023

Study information

• Verified date: January 2023
• Source: New World Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 5, 2023
• Est. primary completion date: July 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

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

Locations

Country	Name	City	State
Mexico	Clinica Laser y Ultrasonido Ocular de Puebla	Puebla

Sponsors (1)

Lead Sponsor	Collaborator
New World Medical, Inc.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of AEs	comparison of intra-operative and post-operative adverse events observed to events reported in published literature,	12 months
Secondary	Surgical Experience Evaluation	An evaluation of the surgical experience using feedback questionnaire to describe specific note of performance characteristics of each implant.	12 months
Secondary	Change in IOP	Change in IOP from Screening to M12	12 months
Secondary	Change in IOP Lowering Medications	Change in IOP lowering medications from Screening to M12	12 months