Open Angle Glaucoma, Pigmentary Glaucoma, Primary Open Angle Glaucoma, Pseudoexfoliation Glaucoma
Conditions
Brief summary
The purpose of this study is to assess the safety and effectiveness of the Hydrus Microstent for lowering intraocular pressure (IOP) in pseudophakic patients with open-angle glaucoma for whom IOP is not sufficiently controlled on topical hypotensive medication and prior to incisional glaucoma surgery.
Detailed description
Qualified subjects will undergo ocular hypotensive medication washout prior to implantation with the Hydrus Microstent. Following implantation on Day 0, subjects will attend 8 scheduled postoperative visits: Day 1, Week 1, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24. A decision to terminate the study was made by the Sponsor arising from challenges with enrollment of the target study population, leading to suspension of enrollment and revision of the follow-up period to 12 months. The total duration of participation for each subject was approximately 13 months including the medication washout prior to implantation. This study was initiated by Ivantis, Inc. Ivantis was acquired by Alcon Research, and Alcon assumed sponsorship of the study in November 2022.
Interventions
DEVICEHydrus Microstent
Minimally invasive glaucoma surgery device implanted into the Schlemm's canal of the eye to provide a natural outflow pathway for aqueous humor, leading to a reduction in intraocular pressure (IOP). The Hydrus Microstent is intended for lifetime use of the glaucoma patient.
PROCEDUREOphthalmic surgery
Implantation of the Hydrus Microstent performed under either local or topical ophthalmic anesthesia
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Early or moderate glaucomatous optic nerve damage; * Uncomplicated cataract surgery with well centered posterior chamber IOL greater than or equal to 365 days prior to the screening visit; * Inadequately controlled IOP; * Shaffer angle grade III-IV in all four quadrants; * Age appropriate minimum central endothelial cell density; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Diagnosis of acute angle closure, chronic angle closure, or congenital, malignant, or developmental glaucoma; * Requires oral hypotensive medications; * Shallow or flat anterior chamber; * Prior glaucoma surgery; * Ocular hypertension; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects (Responders) with unmedicated DIOP greater than 6 mmHg and less than or equal to 21 mmHg with a reduction of greater than or equal to 20% from baseline and absence of secondary glaucoma surgery or loss of light perception | Baseline, Month 12 postoperative | Intraocular pressure (IOP) will be measured using Goldmann tonometry. Three separate IOP measurements will be taken over an 8-hour period and averaged together to achieve mean diurnal intraocular pressure (DIOP). Baseline is defined as post ocular hypotensive medication washout and prior to Day 0, day of surgery. This is a co-primary endpoint. No hypothesis testing is prespecified. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Unmedicated DIOP From Baseline to Month 12 and Absence of Secondary Glaucoma Surgery or Loss of Light Perception | Baseline, Month 12 postoperative | IOP will be measured using Goldmann Applanation tonometry. Three separate IOP measurements will be taken over an 8-hour period and averaged together to achieve mean DIOP. Baseline will be defined as post ocular hypotensive medication washout and prior to Day 0, day of surgery. A negative change value represents an improvement. This is a co-primary endpoint. No hypothesis testing is prespecified. |
Countries
United States
Outcome results
None listed