Trial Outcomes & Findings for Safety & Effectiveness Study of the Hydrus Microstent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery (HORIZON) (NCT NCT01539239)
NCT ID: NCT01539239
Last Updated: 2021-03-12
Results Overview
Percentage of eyes in which diurnal IOP was reduced by greater than or equal to 20% at 24 months postoperative compared to baseline after washout of topical glaucoma medications.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1143 participants
Primary outcome timeframe
Baseline and 24 months
Results posted on
2021-03-12
Participant Flow
Patients were screened and enrolled at 38 investigational sites in the United States and other countries.
Of the 1,143 enrolled, 572 were screen failures and 15 were excluded intraoperatively due to failure to meet all intraoperative eligibility criteria. At the time of reporting, 556 patients randomized are available for analysis.
Participant milestones
| Measure |
Hydrus Aqueous Implant (Treatment)
Cataract surgery plus Hydrus Aqueous Implant
Hydrus Aqueous Implant: The Hydrus Aqueous Implant is a crescent-shaped nitinol device intended to be a permanent implant placed through the trabecular meshwork into Schlemm's Canal, immediately following placement of a monofocal IOL.
|
Cataract Surgery (Control)
Cataract surgery only
Cataract surgery: A monofocal intraocular lens (IOL) placed during the cataract surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
369
|
187
|
|
Overall Study
COMPLETED
|
357
|
170
|
|
Overall Study
NOT COMPLETED
|
12
|
17
|
Reasons for withdrawal
| Measure |
Hydrus Aqueous Implant (Treatment)
Cataract surgery plus Hydrus Aqueous Implant
Hydrus Aqueous Implant: The Hydrus Aqueous Implant is a crescent-shaped nitinol device intended to be a permanent implant placed through the trabecular meshwork into Schlemm's Canal, immediately following placement of a monofocal IOL.
|
Cataract Surgery (Control)
Cataract surgery only
Cataract surgery: A monofocal intraocular lens (IOL) placed during the cataract surgery.
|
|---|---|---|
|
Overall Study
Death
|
5
|
5
|
|
Overall Study
Lost to Follow-up
|
7
|
12
|
Baseline Characteristics
Safety & Effectiveness Study of the Hydrus Microstent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery (HORIZON)
Baseline characteristics by cohort
| Measure |
Hydrus Aqueous Implant (Treatment)
n=369 Participants
Cataract surgery plus Hydrus Aqueous Implant
Hydrus Aqueous Implant: The Hydrus Aqueous Implant is a crescent-shaped nitinol device intended to be a permanent implant placed through the trabecular meshwork into Schlemm's Canal, immediately following placement of a monofocal IOL.
|
Cataract Surgery (Control)
n=187 Participants
Cataract surgery only
Cataract surgery: A monofocal intraocular lens (IOL) placed during the cataract surgery.
|
Total
n=556 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.1 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
71.2 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
71.1 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
206 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
311 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
163 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
245 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
345 Participants
n=5 Participants
|
168 Participants
n=7 Participants
|
513 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
21 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
45 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
291 Participants
n=5 Participants
|
153 Participants
n=7 Participants
|
444 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 monthsPopulation: Intent-to-Treat (ITT)
Percentage of eyes in which diurnal IOP was reduced by greater than or equal to 20% at 24 months postoperative compared to baseline after washout of topical glaucoma medications.
Outcome measures
| Measure |
Hydrus Aqueous Implant (Treatment)
n=369 Eyes
Cataract surgery plus Hydrus Aqueous Implant
Hydrus Aqueous Implant: The Hydrus Aqueous Implant is a crescent-shaped nitinol device intended to be a permanent implant placed through the trabecular meshwork into Schlemm's Canal, immediately following placement of a monofocal IOL.
|
Cataract Surgery (Control)
n=187 Eyes
Cataract surgery only
Cataract surgery: A monofocal intraocular lens (IOL) placed during the cataract surgery.
|
|---|---|---|
|
Reduction in Mean Diurnal IOP From Baseline at 24 Months Following Medication Washout.
|
77.2 percentage of eyes
|
57.8 percentage of eyes
|
SECONDARY outcome
Timeframe: Baseline and 24 monthsPopulation: Intent-to-Treat (ITT)
Mean diurnal IOP change from baseline at 24 months between both groups after washout of topical glaucoma medications.
Outcome measures
| Measure |
Hydrus Aqueous Implant (Treatment)
n=369 Participants
Cataract surgery plus Hydrus Aqueous Implant
Hydrus Aqueous Implant: The Hydrus Aqueous Implant is a crescent-shaped nitinol device intended to be a permanent implant placed through the trabecular meshwork into Schlemm's Canal, immediately following placement of a monofocal IOL.
|
Cataract Surgery (Control)
n=187 Participants
Cataract surgery only
Cataract surgery: A monofocal intraocular lens (IOL) placed during the cataract surgery.
|
|---|---|---|
|
Mean Diurnal Washed Out IOP Change From Baseline at 24 Months Compared Between Treatment and Control Groups.
|
-7.5 mmHg
Standard Deviation 4.1
|
-5.3 mmHg
Standard Deviation 3.9
|
Adverse Events
Hydrus Aqueous Implant (Treatment)
Serious events: 10 serious events
Other events: 106 other events
Deaths: 5 deaths
Cataract Surgery (Control)
Serious events: 6 serious events
Other events: 24 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Hydrus Aqueous Implant (Treatment)
n=369 participants at risk
Cataract surgery plus Hydrus Aqueous Implant
Hydrus Aqueous Implant: The Hydrus Aqueous Implant is a crescent-shaped nitinol device intended to be a permanent implant placed through the trabecular meshwork into Schlemm's Canal, immediately following placement of a monofocal IOL.
|
Cataract Surgery (Control)
n=187 participants at risk
Cataract surgery only
Cataract surgery: A monofocal intraocular lens (IOL) placed during the cataract surgery.
|
|---|---|---|
|
Eye disorders
BCVA loss greater than or equal to 2 lines ETDRS greater than or equal to 3 months
|
0.00%
0/369 • 24 months
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
|
0.53%
1/187 • Number of events 1 • 24 months
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
|
|
Eye disorders
Corneal Edema Mild to Mod after 1 month
|
0.27%
1/369 • Number of events 1 • 24 months
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
|
0.00%
0/187 • 24 months
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
|
|
Eye disorders
Glaucoma progression
|
0.00%
0/369 • 24 months
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
|
0.53%
1/187 • Number of events 1 • 24 months
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
|
|
Eye disorders
Neovascular Glaucoma
|
0.00%
0/369 • 24 months
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
|
0.53%
1/187 • Number of events 1 • 24 months
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
|
|
Eye disorders
Repair of malpositioned IOL haptic
|
0.27%
1/369 • Number of events 1 • 24 months
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
|
0.00%
0/187 • 24 months
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
|
|
Eye disorders
Orbital hemangioma
|
0.27%
1/369 • Number of events 1 • 24 months
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
|
0.00%
0/187 • 24 months
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
|
|
Eye disorders
Squamous cell carcinoma of the conjunctiva
|
0.27%
1/369 • Number of events 1 • 24 months
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
|
0.00%
0/187 • 24 months
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
|
|
Eye disorders
Worsening of visual field MD by greater than or equal to 2.5 dB compared with preoperative
|
0.00%
0/369 • 24 months
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
|
0.53%
1/187 • Number of events 1 • 24 months
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
|
|
Eye disorders
Retinal Complications
|
1.6%
6/369 • Number of events 6 • 24 months
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
|
2.1%
4/187 • Number of events 5 • 24 months
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
|
Other adverse events
| Measure |
Hydrus Aqueous Implant (Treatment)
n=369 participants at risk
Cataract surgery plus Hydrus Aqueous Implant
Hydrus Aqueous Implant: The Hydrus Aqueous Implant is a crescent-shaped nitinol device intended to be a permanent implant placed through the trabecular meshwork into Schlemm's Canal, immediately following placement of a monofocal IOL.
|
Cataract Surgery (Control)
n=187 participants at risk
Cataract surgery only
Cataract surgery: A monofocal intraocular lens (IOL) placed during the cataract surgery.
|
|---|---|---|
|
Eye disorders
Anterior uveitis/iritis (non-persistent)
|
5.1%
19/369 • Number of events 19 • 24 months
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
|
1.6%
3/187 • Number of events 3 • 24 months
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
|
|
Eye disorders
Conjunctivitis
|
5.7%
21/369 • Number of events 27 • 24 months
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
|
7.0%
13/187 • Number of events 14 • 24 months
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
|
|
Eye disorders
Device obstruction, partial or complete
|
7.3%
27/369 • Number of events 27 • 24 months
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
|
0.00%
0/187 • 24 months
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
|
|
Eye disorders
Peripheral anterior synechiae without device obstruction
|
7.3%
27/369 • Number of events 27 • 24 months
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
|
0.00%
0/187 • 24 months
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
|
|
Eye disorders
Worsening of visual field MD by greater than or equal to 2.5 dB compared with preoperative
|
4.3%
16/369 • Number of events 16 • 24 months
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
|
4.8%
9/187 • Number of events 9 • 24 months
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sites participating in the trial may not publish their single center results until the aggregate study results have been published unless first obtaining written consent from the sponsor.
- Publication restrictions are in place
Restriction type: OTHER