Hydrus® Microstent New Enrollment Post-Approval Study
ConditionPrimary Open Angle Glaucoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorAlcon Research
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Closed angle forms of glaucoma;
Congenital or developmental glaucoma;
Secondary glaucoma;
Use of more than 4 ocular hypotensive medications;
Trial design
Treatments tested in this trial
- Hydrus Microstent
- Cataract surgery
- Monofocal IOL
Treatment groups
545 Participants
are divided into 1 treatment groupLocations
22California
Coastal Vision92618, Irvine United States
Sacramento Eye Consultants95815, Sacramento United States
Colorado
Eye Center of Northern Colorado80538, Loveland United States
Iowa
Jones Eye Center PC51104, Sioux City United States
Sponsors and collaborators
Alcon Research
Lead sponsor
Source ClinicalTrials.gov