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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Hydrus Microstent
DeviceCrescent-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.
Cataract surgery
Procedure/SurgeryCataract surgery performed using standard anesthesia and phacoemulsification techniques
Monofocal IOL
DeviceCommercially available monofocal intraocular lens as determined by the investigator
Treatment groups
545 Participants
are divided into 1 treatment groupGroup A: Hydrus MicrostentExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Rate of occurrence of clinically significant device malposition associated with clinical sequelae
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 loss ≥30 percent, compromised corneal function, best-corrected visual acuity (BCVA) loss of 2 lines (10 letters) or more on the ETDRS chart, device obstruction requiring secondary surgical intervention, persistent anterior chamber inflammation with peripheral anterior synechiae, persistent anterior chamber inflammation without peripheral anterior synechiae, and chronic pain.
Time frame
Day 0 operative, up to Month 24 postoperativeSecondary outcomes
1
Rate of occurrence of intraoperative ocular adverse events
Intraoperative ocular adverse events as specified in the protocol include hyphema obscuring the surgeon's view, choroidal hemorrhage or effusion, choroidal detachment, significant iris injury or trauma, corneal abrasion, corneal edema, zonular dialysis, cyclodialysis, cyclodialysis cleft, iridodialysis, vitreous loss not associated with the cataract procedure, inadvertent perforation of the sclera, and Descemet's membrane detachment.
Time frame
Day 0 operative2
Rate of occurrence of sight threatening postoperative adverse events
Sight threatening, post-operative adverse events as specified in the protocol include endophthalmitis, corneal decompensation, severe retinal detachment, severe choroidal hemorrhage, severe choroidal detachment, and aqueous misdirection.
Time frame
Up to Month 243
Rate of occurrence of other postoperative ocular adverse events
Other postoperative ocular adverse events as specified in the protocol include anterior uveitis/iritis, non-persistent \& persistent, best corrected visual acuity (BCVA) loss of 2 lines or more, chronic pain, device migration, device obstruction, peripheral anterior synechiae (PAS), ocular secondary surgical interventions for intraocular pressure (IOP) or glaucoma management, hypotony at or after 1 month postop, hyphema, corneal opacification, corneal edema persisting or severe corneal edema, other retinal complications, elevated mean IOP \>/=10 millimeters mercury (mmHg) vs screening, iris prolapse/wound incarceration, significant foreign body sensation at or after 3 months postop, surgical re-intervention, and worsening of visual field.
Time frame
Up to Month 24Sponsors and contacts
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Source ClinicalTrials.gov