Trial Outcomes & Findings for Hydrus Microstent for Refractory Open-Angle Glaucoma (NCT NCT03267134)

Last Updated: 2026-01-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

217 participants

Primary outcome timeframe

Baseline, Month 12

Results posted on

2026-01-14

Participant Flow

Participants were recruited from 20 investigative sites located in the United States (16), Philippines (1), Spain (1), United Kingdom (1), and Colombia (1).

Of the 217 subjects who signed an informed consent, 117 were exited from the study prior to attempted implantation as screen failures. This reporting group includes all subjects for whom a Hydrus Microstent was implanted or implantation was attempted (100) (Safety Analysis Population).

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	Hydrus Microstent Hydrus Microstent implanted in the eye per the supplied Hydrus Microstent Instructions for Use and associated training, Only one eye (study eye) was implanted.
Overall Study STARTED	100 100
Overall Study COMPLETED	100 100
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hydrus Microstent for Refractory Open-Angle Glaucoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hydrus Microstent n=100 Participants Hydrus Microstent implanted in the eye per the supplied Hydrus Microstent Instructions for Use and associated training, Only one eye (study eye) was implanted.
Age, Continuous	71.3 years STANDARD_DEVIATION 10.0 • n=9 Participants
Age, Customized Less than 60 years	13 participants n=9 Participants
Age, Customized 60 years to less than 70 years	28 participants n=9 Participants
Age, Customized 70 to less than 80 years	35 participants n=9 Participants
Age, Customized 80 years and greater	24 participants n=9 Participants
Sex: Female, Male Female	52 Participants n=9 Participants
Sex: Female, Male Male	48 Participants n=9 Participants
Race/Ethnicity, Customized Asian	7 Participants n=9 Participants
Race/Ethnicity, Customized Black or African American	14 Participants n=9 Participants
Race/Ethnicity, Customized Mestizo	2 Participants n=9 Participants
Race/Ethnicity, Customized White	74 Participants n=9 Participants
Race/Ethnicity, Customized Refuses to Answer/Unknown	3 Participants n=9 Participants

PRIMARY outcome

Timeframe: Baseline, Month 12

Population: Effectiveness Population: All subjects who undergo the Hydrus implantation surgery and are not discontinued early from the study due to unrelated reasons such as death or relocation. For non-responders, data was imputed as specified in the protocol. No hypothesis testing was pre-specified for this outcome measure.

Outcome measures

Outcome measures
Measure	Hydrus Microstent n=100 Participants Hydrus Microstent implanted in the eye per the supplied Hydrus Microstent Instructions for Use and associated training, Only one eye (study eye) was implanted.
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	43.0 percentage of subjects

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Hydrus Microstent n=100 eyes Hydrus Microstent implanted in the eye per the supplied Hydrus Microstent Instructions for Use and associated training, Only one eye (study eye) was implanted.
Mean Change From Baseline in MDIOP at Month 12	-3.77 mmHG Standard Deviation 5.0

Adverse Events

Ocular Adverse Events

Serious events: 5 serious events

Other events: 55 other events

Deaths: 0 deaths

Non-Ocular Adverse Events

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ocular Adverse Events n=100 participants at risk Hydrus Microstent implanted in the eye per the supplied Hydrus Microstent Instructions for Use and associated training, Only one eye (study eye) was implanted.	Non-Ocular Adverse Events n=100 participants at risk Hydrus Microstent implanted in the eye per the supplied Hydrus Microstent Instructions for Use and associated training, Only one eye (study eye) was implanted.
Eye disorders Elevated IOP	1.0% 1/100 • Adverse events were collected from the operative visit to study exit (approximately 12 months). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the Microstent or delivery system.	0.00% 0/100 • Adverse events were collected from the operative visit to study exit (approximately 12 months). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the Microstent or delivery system.
Eye disorders Elevated mean IOP	2.0% 2/100 • Adverse events were collected from the operative visit to study exit (approximately 12 months). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the Microstent or delivery system.	0.00% 0/100 • Adverse events were collected from the operative visit to study exit (approximately 12 months). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the Microstent or delivery system.
Eye disorders Worsening of visual field	3.0% 3/100 • Adverse events were collected from the operative visit to study exit (approximately 12 months). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the Microstent or delivery system.	0.00% 0/100 • Adverse events were collected from the operative visit to study exit (approximately 12 months). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the Microstent or delivery system.

Other adverse events

Other adverse events
Measure	Ocular Adverse Events n=100 participants at risk Hydrus Microstent implanted in the eye per the supplied Hydrus Microstent Instructions for Use and associated training, Only one eye (study eye) was implanted.	Non-Ocular Adverse Events n=100 participants at risk Hydrus Microstent implanted in the eye per the supplied Hydrus Microstent Instructions for Use and associated training, Only one eye (study eye) was implanted.
Eye disorders AC cell or flare requiring change in steroid medication regimen	6.0% 6/100 • Adverse events were collected from the operative visit to study exit (approximately 12 months). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the Microstent or delivery system.	0.00% 0/100 • Adverse events were collected from the operative visit to study exit (approximately 12 months). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the Microstent or delivery system.
Eye disorders BCVA loss at greater than 1 month postoperative	15.0% 15/100 • Adverse events were collected from the operative visit to study exit (approximately 12 months). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the Microstent or delivery system.	0.00% 0/100 • Adverse events were collected from the operative visit to study exit (approximately 12 months). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the Microstent or delivery system.
Eye disorders BCVA loss at less than or equal to 1 month postoperative	10.0% 10/100 • Adverse events were collected from the operative visit to study exit (approximately 12 months). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the Microstent or delivery system.	0.00% 0/100 • Adverse events were collected from the operative visit to study exit (approximately 12 months). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the Microstent or delivery system.
Eye disorders Device obstruction	10.0% 10/100 • Adverse events were collected from the operative visit to study exit (approximately 12 months). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the Microstent or delivery system.	0.00% 0/100 • Adverse events were collected from the operative visit to study exit (approximately 12 months). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the Microstent or delivery system.
Eye disorders Elevated mean IOP at greater than 1 month postoperative	14.0% 14/100 • Adverse events were collected from the operative visit to study exit (approximately 12 months). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the Microstent or delivery system.	0.00% 0/100 • Adverse events were collected from the operative visit to study exit (approximately 12 months). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the Microstent or delivery system.
Eye disorders Elevated mean IOP at less than or equal to 1 month postoperative	16.0% 16/100 • Adverse events were collected from the operative visit to study exit (approximately 12 months). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the Microstent or delivery system.	0.00% 0/100 • Adverse events were collected from the operative visit to study exit (approximately 12 months). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the Microstent or delivery system.
Eye disorders Hypotony (less than 6 mmHg)	7.0% 7/100 • Adverse events were collected from the operative visit to study exit (approximately 12 months). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the Microstent or delivery system.	0.00% 0/100 • Adverse events were collected from the operative visit to study exit (approximately 12 months). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the Microstent or delivery system.
Eye disorders Surgical re-intervention in study eye	15.0% 15/100 • Adverse events were collected from the operative visit to study exit (approximately 12 months). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the Microstent or delivery system.	0.00% 0/100 • Adverse events were collected from the operative visit to study exit (approximately 12 months). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the Microstent or delivery system.
Eye disorders Worsening of visual field	19.0% 19/100 • Adverse events were collected from the operative visit to study exit (approximately 12 months). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the Microstent or delivery system.	0.00% 0/100 • Adverse events were collected from the operative visit to study exit (approximately 12 months). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the Microstent or delivery system.

Additional Information

Clinical Project Lead, CRD Surgical

Alcon Research, LLC

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER