Menu
Recruiting NCT04553523

Hydrus® Microstent New Enrollment Post-Approval Study

No phase Interventional Primary Open Angle Glaucoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hydrus Microstent, Cataract surgery, Monofocal IOL.
Who it may be relevant to
Registry conditions: Primary Open Angle Glaucoma. Basic parameters: from 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Hydrus® Microstent New Enrollment Post-Approval Study: A Prospective, Non-Randomized, Multicenter, Single Arm, Clinical Trial

Overview

The purpose of this post-approval study is to evaluate the rate of Hydrus Microstent malposition and associated clinical sequelae occurring within 24 months post-operation. Qualified subjects will undergo uncomplicated cataract surgery with placement of a monofocal intraocular lens (IOL), followed by implantation of the Hydrus Microstent.

Detailed description

Qualified subjects will attend a screening visit, a surgical visit (Day 0), and 8 scheduled postoperative visits at Day 1, Day 7, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24.

This study was initiated by Ivantis, Inc. Ivantis was acquired by Alcon Research, and Alcon assumed sponsorship of the study in November 2022.

Interventions

  • Device Hydrus Microstent
    Crescent-shaped nitinol device intended as a permanent implant to provide an outflow pathway for aqueous humor. The device is placed through the trabecular meshwork into Schlemm's canal immediately following placement of a monofocal IOL.
  • Procedure Cataract surgery
    Cataract surgery performed using standard anesthesia and phacoemulsification techniques
  • Device Monofocal IOL
    Commercially available monofocal intraocular lens as determined by the investigator

Primary outcome measures

  • Rate of occurrence of clinically significant device malposition associated with clinical sequelae [Time frame: Day 0 operative, up to Month 24 postoperative]
Secondary outcome measures (3)
  • Rate of occurrence of intraoperative ocular adverse events [Time frame: Day 0 operative]
  • Rate of occurrence of sight threatening postoperative adverse events [Time frame: Up to Month 24]
  • Rate of occurrence of other postoperative ocular adverse events [Time frame: Up to Month 24]

Eligibility criteria

Inclusion criteria

  • An operable, age-related cataract with best corrected visual acuity (BCVA) of 20/40 or worse;
  • Diagnosis of primary open angle glaucoma treated with no more than 4 topical hypotensive medications;
  • Optic nerve appearance characteristic of glaucoma;
  • Medicated IOP less than or equal to 31 millimeters mercury (mmHg); Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Closed angle forms of glaucoma;
  • Congenital or developmental glaucoma;
  • Secondary glaucoma;
  • Use of more than 4 ocular hypotensive medications;
  • Previous argon laser trabeculoplasty, trabeculectomy, tube shunts, or any other prior filtration or cilioablative surgery;
  • Prior surgery with implanted device or other surgery involving the trabecular meshwork or Schlemm's canal;
  • Other protocol-defined exclusion criteria may apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 22 centers
  • Coastal Vision — Irvine
  • Sacramento Eye Consultants — Sacramento
  • Eye Center of Northern Colorado — Loveland
  • Jones Eye Center PC — Sioux City
  • Stiles Eyecare Excellence Cataracts and Glaucoma — Overland Park
  • Visionary Eye Doctors — Rockville
  • Fraser Eye Care Center — Fraser
  • Twin Cities Eye Consultants — Coon Rapids
  • … and 14 more centers

Identifiers

NCT: NCT04553523 · CP 18-001 · GLI314-C003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗