Safety and Effectiveness of the Hydrus Microstent

Not Applicable

Terminated

Conditions: Open Angle Glaucoma
Primary Open Angle Glaucoma
Pseudoexfoliation Glaucoma
Pigmentary Glaucoma

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.

Recruitment & Eligibility

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 exclusion criteria may apply.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Locations (5): Vold Vision PLLC
🇺🇸
Bentonville, Arkansas, United States
The Eye Clinic of Florida
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Zephyrhills, Florida, United States
Fraser Eye Care Center
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Fraser, Michigan, United States
Cincinnati Eye / Apex Eye
🇺🇸
Mason, Ohio, United States
Eye Centers Of Racine And Kenosha
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Kenosha, Wisconsin, United States