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Completed

NCT Number: NCT05131087

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

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

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

22 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Laser y Ultrasonido Ocular de Puebla

Puebla City, 72530, Mexico

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cadence implant

Device

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 outcomes

  1. Assessment of AEs

    Time frame: 12 months

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

Secondary outcomes

  1. 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.

  2. Change in IOP

    Time frame: 12 months

    Change in IOP from Screening to M12

  3. Change in IOP Lowering Medications

    Time frame: 12 months

    Change in IOP lowering medications from Screening to M12

Sponsors and collaborators

Lead sponsor

New World Medical, Inc.

Industry

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 23, 2021
Registry last updated
Oct 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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