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Hydrus® Microstent New Enrollment Post-Approval Study

Study acronym: CONFIRM
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 31 days later Aug 2028 → Oct 2028
See other at-risk trials from Alcon Research

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Aug 2028 to Oct 2028
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 2 of 3 entries
    • Site details revised at 3 of 22 sites
  2. Primary and study completion pushed from Jun 2028 to Aug 2028v8
  3. 2 versions Re-verified since Jun 2, 2025, no change to tracked fieldsv6-v7
  4. Primary and study completion dates: Jan 2027 to Jun 2028v5
  5. Study sites: 13 to 22
    • Primary and study completion dates: Dec 2026 to Jan 2027
    v4
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  1. Lead sponsor: Ivantis, Inc. to Alcon Researchv3 Show 8 more changesShow less
    • Enrollment target: 330 to 545
    • Primary endpoint revised
    • Study sites: 15 to 13
    • Interventions: Hydrus Microstent (Device) to Cataract surgery (Procedure), Hydrus Microstent (Device), Monofocal IOL (Device)
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints revised (3)
    • Study description expanded, about 58 words
    • Study title revised
  2. Primary completion date: May 2024 to Dec 2026v2 Show 4 more changesShow less
    • Primary endpoint revised
    • Study sites: 10 to 15
    • Study completion date: Sep 2024 to Dec 2026
    • Secondary endpoints revised (3)
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Alcon Research
30 trials monitored
See 3 trials at risk
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.
Trial Details
NCT Number NCT04553523
Lead Sponsor Alcon Research
Conditions
(from sponsor)		 Primary Open Angle Glaucoma
Related terms Glaucoma, Open-Angle
Enrollment 545 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov