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

Not Applicable

Completed

• Conditions: Glaucoma
• Interventions: Device: Cadence implant

• Registration Number: NCT05131087
• Lead Sponsor: New World Medical, Inc.

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

Study Timeline

• Study Start: 2020-10-08
• Study First Submitted: 2021-11-02
• Study First Submitted QC: 2021-11-10
• Study First Posted: 2021-11-23
• Status Verified: 2023-01
• Primary Completion: 2023-07-05
• Study Completion: 2023-07-05
• Last Update Submitted: 2023-10-11
• Last Update Posted: 2023-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 22-80 years of age.
• moderate to severe refractory glaucoma
• Able to consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cadence	Cadence implant	Cadence procedure

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinica Laser y Ultrasonido Ocular de Puebla; 🇲🇽 Puebla, Mexico