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

October 11, 2023 updated by: New World Medical, Inc.
To evaluate safety, effectiveness, and the surgical performance of CADENCE in patients with refractory glaucoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Puebla, Mexico, 72530
        • Clinica Laser y Ultrasonido Ocular de Puebla

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cadence
Cadence procedure
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
Change in IOP
Time Frame: 12 months
Change in IOP from Screening to M12
12 months
Change in IOP Lowering Medications
Time Frame: 12 months
Change in IOP lowering medications from Screening to M12
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New World Medical, Inc.

Investigators

  • Study Director: Mark Sun, PhD, New World Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2020

Primary Completion (Actual)

July 5, 2023

Study Completion (Actual)

July 5, 2023

Study Registration Dates

First Submitted

November 2, 2021

First Submitted That Met QC Criteria

November 10, 2021

First Posted (Actual)

November 23, 2021

Study Record Updates

Last Update Posted (Actual)

October 13, 2023

Last Update Submitted That Met QC Criteria

October 11, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DF8-CL-20-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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