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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
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.
Implantation of the Hydrus Microstent performed under either local or topical ophthalmic anesthesia
Vold Vision PLLC
Bentonville, Arkansas, United States
The Eye Clinic of Florida
Zephyrhills, Florida, United States
Fraser Eye Care Center
Fraser, Michigan, United States
Cincinnati Eye / Apex Eye
Mason, Ohio, United States
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
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.
Time frame: Baseline, Month 12 postoperative
Mean Change in Unmedicated DIOP From Baseline to Month 12 and Absence of Secondary Glaucoma Surgery or Loss of Light Perception
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.
Time frame: Baseline, Month 12 postoperative
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Eye Centers Of Racine And Kenosha
Kenosha, Wisconsin, United States