Hydrus Microstent for Refractory Open-A… | Clinical Trial

Key information

Conditions

Open-angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clínica Oftalmológica, Barranquilla, Colombia

About this study

Participants will attend a screening visit, a baseline visit, a surgery visit, and 8 post-operative visits (Day 1, Day 7, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12), for a total individual duration of approximately 14 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Open-angle glaucoma with optic nerve pathology;
BCVA of 20/80 or better in study eye;
Refractory glaucoma;
Other protocol-specified inclusion criteria may apply.

Exclusion criteria

Secondary glaucoma other than pseudoexfoliative and pigmentary glaucoma;
Acute angle closure, chronic angle closure, or congenial, malignant, or developmental glaucoma;
Pre-perimetric glaucoma;
Ocular hypertension
Shallow or flat anterior chamber;
Other protocol-specified exclusion criteria may apply.

Treatment and study plan

Hydrus Microstent

Device

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.

Ophthalmic surgery

Procedure

Implantation of the Hydrus Microstent performed under either local or topical ophthalmic anesthesia

Primary outcomes

Percentage of Subjects With Greater Than or Equal to a 20 Percent Decrease From Baseline in Mean Diurnal Intraocular Pressure (MDIOP) at Month 12 While Maintaining the Same or Fewer Number of Medications as at Baseline

Time frame: Baseline, Month 12

Intraocular pressure was measured using Goldmann Applanation tonometry. Three separate IOP measurements were taken over an 8-hour period and averaged together to achieve mean diurnal intraocular pressure.

Secondary outcomes

Mean Change From Baseline in MDIOP at Month 12

Time frame: Baseline, Month 12

Intraocular pressure was measured using Goldmann Applanation tonometry and recorded in millimeters mercury (mmHG). Three separate IOP measurements were taken over an 8-hour period and averaged together to achieve mean diurnal intraocular pressure. A negative number represents a reduction from baseline. For non-responders, data was imputed as specified in the protocol. No hypothesis testing was pre-specified for this outcome measure.

Sponsors and collaborators

Lead sponsor

Ivantis, Inc.

Industry

Registry information

Official study title

The Hydrus Microstent for Refractory Open-Angle Glaucoma: A Prospective, Multicenter Clinical Trial (Hydrus VII Study)

Acronym: SUMMIT

Important dates

Study start: 2017
Primary completion: 2022
Study completion: 2022
First posted: Aug 30, 2017
Registry last updated: Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed