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NCT04553523 · ClinicalTrials.gov registry record · NA
Hydrus® Microstent New Enrollment Post-Approval Study
A NA study of Primary Open Angle Glaucoma, sponsored by Alcon Research.
- Recruiting
- Registry status
- NA
- Development phase
- 545
- Enrollment target
- 20
- Study locations
NCT04553523: Recruiting NA study of Primary Open Angle Glaucoma, sponsored by Alcon Research.
NCT04553523 is a NA study of Primary Open Angle Glaucoma that is actively recruiting participants, run by Alcon Research. The registered enrollment target is 545 participants, above the 266-participant average among 19 other Primary Open Angle Glaucoma trials with a reported enrollment target (105% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04553523, a NA study of Primary Open Angle Glaucoma, is actively recruiting participants, sponsored by Alcon Research.
- RECRUITING
- Registry status
- NA
- Development phase
- 545 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
The position of the implant will be assessed visually intraoperatively and at each postoperative follow-up visit. Examples of clinically significant device malposition associated with clinical sequelae as listed in the protocol include secondary surgical intervention to modify device position or to remove the device (explantation), corneal endothelial touch by device, iris touch by the device associated with intraocular inflammation, pigment dispersion or other sequelae, central endothelial cell
Conditions Studied
Interventions
- DEVICE Hydrus Microstent
- PROCEDURE Cataract surgery
- DEVICE Monofocal IOL
Study Locations (20)
Texas
- Texan Eye / Keystone Research - Austin
- Glaucoma Associates Of Texas - Dallas
- El Paso Eye Surgeons - El Paso
- Texas Eye Research Center - Hurst
Ohio
- Cleveland Eye Clinic - Brecksville
- Cincinnati Eye Institute - Cincinnati
- Cincinnati Eye / Apex Eye - Mason
California
- Coastal Vision - Irvine
- Sacramento Eye Consultants - Sacramento
Missouri
- Midwest Vision Research Foundation - Chesterfield
- Moyes Eye Center - Kansas City
Colorado
- Eye Center of Northern Colorado - Loveland
Iowa
- Jones Eye Center PC - Sioux City
Kansas
- Stiles Eyecare Excellence Cataracts and Glaucoma - Overland Park
Maryland
- Visionary Eye Doctors - Rockville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 545 participants |
| Start Date | 2020-08-25 |
| Est. Completion | 2028-06 |
| Phase | NA |
What NCT04553523 shows while recruiting
NCT04553523 is an interventional study that assigns participants to a tested intervention. The registered 545 participants enrollment target is mid-sized for trials with a published cap, above the 266-participant average among 19 other Primary Open Angle Glaucoma trials with a reported enrollment target (105% higher).
The record links to 1 condition, with Primary Open Angle Glaucoma appearing as the primary indexed condition, and to 3 interventions - of which Hydrus Microstent is the first listed.
NCT04553523 names 20 study sites across 13 states, led by Texas, Ohio, California.
Frequently Asked Questions
What is clinical trial NCT04553523 about?
NCT04553523 is a clinical study titled "Hydrus® Microstent New Enrollment Post-Approval Study". 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 b...
What is the current status of trial NCT04553523?
This trial is currently recruiting. It is a NA study. The enrollment target is 545 participants. The study started on 2020-08-25. Estimated completion is 2028-06.
What conditions does trial NCT04553523 study?
This clinical trial studies the following conditions: Primary Open Angle Glaucoma.
What interventions are being tested in trial NCT04553523?
The interventions under investigation include: Hydrus Microstent (DEVICE), Cataract surgery (PROCEDURE), Monofocal IOL (DEVICE).
Who is sponsoring clinical trial NCT04553523?
This trial is sponsored by Alcon Research, which has 275 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04553523 being conducted?
This trial has 20 study locations across California, Colorado, Iowa, Kansas, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04553523's enrollment target sits among peer trials
545 2nd of 19 the highest of 19 other Primary Open Angle Glaucoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Primary Open Angle Glaucoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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