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

Primary Purpose

Glaucoma

Status

Completed

Phase

Not Applicable

Locations

Mexico

Study Type

Interventional

Intervention

Cadence implant

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring glaucoma

Eligibility Criteria

22 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Clinica Laser y Ultrasonido Ocular de Puebla

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cadence

Arm Description

Cadence procedure

Outcomes

Primary Outcome Measures

Assessment of AEs

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

Secondary Outcome Measures

Surgical Experience Evaluation

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

Change in IOP

Change in IOP from Screening to M12

Change in IOP Lowering Medications

Change in IOP lowering medications from Screening to M12

Full Information

NCT ID

NCT05131087

First Posted

November 2, 2021

Last Updated

October 11, 2023

Sponsor

New World Medical, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05131087

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

October 8, 2020 (Actual)

Primary Completion Date

July 5, 2023 (Actual)

Study Completion Date

July 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

New World Medical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma

Keywords

glaucoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Open Label

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cadence

Arm Type

Experimental

Arm Description

Cadence procedure

Intervention Type

Device

Intervention Name(s)

Cadence implant

Intervention Description

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

Primary Outcome Measure Information:

Title

Assessment of AEs

Description

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Surgical Experience Evaluation

Description

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

Time Frame

12 months

Title

Change in IOP

Description

Change in IOP from Screening to M12

Time Frame

12 months

Title

Change in IOP Lowering Medications

Description

Change in IOP lowering medications from Screening to M12

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Sun, PhD

Organizational Affiliation

New World Medical, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Clinica Laser y Ultrasonido Ocular de Puebla

City

Puebla

ZIP/Postal Code

72530

Country

Mexico

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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