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 groupSponsors and collaborators
Source ClinicalTrials.gov