NCT05131087

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 8, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 23, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2023

Completed
Last Updated

October 13, 2023

Status Verified

January 1, 2023

Enrollment Period

2.7 years

First QC Date

November 2, 2021

Last Update Submit

October 11, 2023

Conditions

Glaucoma

Keywords

glaucoma

Outcome Measures

Primary Outcomes (1)

  • Assessment of AEs

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

    12 months

Secondary Outcomes (3)

  • Surgical Experience Evaluation

    12 months

  • Change in IOP

    12 months

  • Change in IOP Lowering Medications

    12 months

Study Arms (1)

Cadence

EXPERIMENTAL

Cadence procedure

Device: Cadence implant

Interventions

Cadence implantDEVICE

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

Cadence

Eligibility Criteria

Age22 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Laser y Ultrasonido Ocular de Puebla

Puebla City, 72530, Mexico

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Mark Sun, PhD

    New World Medical, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open Label
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2021

First Posted

November 23, 2021

Study Start

October 8, 2020

Primary Completion

July 5, 2023

Study Completion

July 5, 2023

Last Updated

October 13, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)