Trial Outcomes & Findings for Comparing Hydrus Microstent(TM) to the iStent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery (NCT NCT02024464)

Results Overview

Intraocular pressure (IOP) was measured using Goldmann applanation tonometry and averaged over the 8 am, 12 pm, and 4 pm time points. IOP was recorded in millimeters mercury (mmHg). The IOP assessment occurred after a protocol-specified wash-out period from all glaucoma medications.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

306 participants

Primary outcome timeframe

Month 12: 8 am, 12 pm, 4 pm

Results posted on

2024-07-03

Participant Flow

Patients were screened and enrolled at 13 investigational sites outside of the United States

This reporting group includes all randomized patients (306).

Participant milestones

Participant milestones
Measure	Hydrus Microstent Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the Hydrus Microstent in one eye (study eye)	iStent Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the iStent Trabecular Micro Bypass in one eye (study eye)
Overall Study STARTED	154	152
Overall Study COMPLETED	144	141
Overall Study NOT COMPLETED	10	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Hydrus Microstent Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the Hydrus Microstent in one eye (study eye)	iStent Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the iStent Trabecular Micro Bypass in one eye (study eye)
Overall Study Discontinued	5	4
Overall Study Missed Visits	1	0
Overall Study Lost to Follow-up	4	7

Baseline Characteristics

Comparing Hydrus Microstent(TM) to the iStent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hydrus Microstent n=154 Participants Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the Hydrus Microstent in one eye (study eye)	iStent n=152 Participants Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the iStent Trabecular Micro Bypass in one eye (study eye)	Total n=306 Participants Total of all reporting groups
Age, Continuous	72.5 years STANDARD_DEVIATION 7.2 • n=93 Participants	71.5 years STANDARD_DEVIATION 7.5 • n=4 Participants	72.0 years STANDARD_DEVIATION 7.3 • n=27 Participants
Sex: Female, Male Female	86 Participants n=93 Participants	71 Participants n=4 Participants	157 Participants n=27 Participants
Sex: Female, Male Male	68 Participants n=93 Participants	81 Participants n=4 Participants	149 Participants n=27 Participants
Race/Ethnicity, Customized Caucasian/White European	103 Participants n=93 Participants	106 Participants n=4 Participants	209 Participants n=27 Participants
Race/Ethnicity, Customized Black or African Descent	4 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants
Race/Ethnicity, Customized Asian	21 Participants n=93 Participants	21 Participants n=4 Participants	42 Participants n=27 Participants
Race/Ethnicity, Customized Native North American	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic/Latino/Central & South	24 Participants n=93 Participants	22 Participants n=4 Participants	46 Participants n=27 Participants
Race/Ethnicity, Customized Other	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants

PRIMARY outcome

Timeframe: Month 12: 8 am, 12 pm, 4 pm

Population: Intent-to-Treat (ITT) with verifiable data at visit. ITT subjects with secondary glaucoma or pressure lowering procedures, terminal wash-out exemptions, or missed diurnal IOP assessments are counted as failures for response metrics and are assigned a zero value for change in DIOP for the effectiveness endpoints.

Intraocular pressure (IOP) was measured using Goldmann applanation tonometry and averaged over the 8 am, 12 pm, and 4 pm time points. IOP was recorded in millimeters mercury (mmHg). The IOP assessment occurred after a protocol-specified wash-out period from all glaucoma medications.

Outcome measures

Outcome measures
Measure	Hydrus Microstent n=139 eyes Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the Hydrus Microstent in one eye (study eye).	iStent n=141 eyes Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the iStent Trabecular Micro Bypass in one eye (study eye)
Unmedicated Mean Diurnal Intraocular Pressure (DIOP) at Month 12	16.9 mmHg Standard Deviation 4.5	18.1 mmHg Standard Deviation 4.9

SECONDARY outcome

Timeframe: Month 12: 8 am, 12 pm, and 4 pm

Population: Intent-to-Treat (ITT) with verifiable data at visit. ITT subjects with secondary glaucoma or pressure lowering procedures, terminal wash-out exemptions, or missed diurnal IOP assessments are counted as failures for response metrics and are assigned a zero value for change in DIOP for the effectiveness endpoints.

Intraocular pressure (IOP) was measured using Goldmann applanation tonometry and averaged over the 8 am, 12 pm, and 4 pm time points. IOP was recorded in millimeters mercury (mmHg). The IOP assessment occurred after a protocol-specified wash-out period from all glaucoma medications.

Outcome measures

Outcome measures
Measure	Hydrus Microstent n=139 eyes Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the Hydrus Microstent in one eye (study eye).	iStent n=141 eyes Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the iStent Trabecular Micro Bypass in one eye (study eye)
Percentage of Subjects With 20% Reduction From Baseline in Unmedicated DIOP at Month 12	82.0 percentage of subjects	83.7 percentage of subjects

SECONDARY outcome

Timeframe: Month 12: 8 am, 12 pm, 4 pm

Population: Intent-to-Treat (ITT) with verifiable data at visit. ITT subjects with secondary glaucoma or pressure lowering procedures, terminal wash-out exemptions, or missed diurnal IOP assessments are counted as failures for response metrics and are assigned a zero value for change in DIOP for the effectiveness endpoints.

Intraocular pressure (IOP) was measured using Goldmann applanation tonometry and averaged over the 8 am, 12 pm, and 4 pm time points. IOP was recorded in millimeters mercury (mmHg). The IOP assessment occurred after a protocol-specified wash-out period from all glaucoma medications.

Outcome measures

Outcome measures
Measure	Hydrus Microstent n=139 eyes Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the Hydrus Microstent in one eye (study eye).	iStent n=141 eyes Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the iStent Trabecular Micro Bypass in one eye (study eye)
Percentage of Subjects With Unmedicated DIOP of Not Less Than 5 mmHg and Not More Than 18 mmHg at Month 12	68.3 percentage of subjects	67.4 percentage of subjects

POST_HOC outcome

Timeframe: Month 24: 8 am, 12 pm, 4 pm

Population: Intent-to-Treat (ITT) with verifiable data at visit. ITT subjects with secondary glaucoma or pressure lowering procedures, terminal wash-out exemptions, or missed diurnal IOP assessments are counted as failures for response metrics and are assigned a zero value for change in DIOP for the effectiveness endpoints.

Intraocular pressure (IOP) was measured using Goldmann applanation tonometry and averaged over the 8 am, 12 pm, and 4 pm time points. IOP was recorded in millimeters mercury (mmHg). The IOP assessment occurred after a protocol-specified wash-out period from all glaucoma medications.

Outcome measures

Outcome measures
Measure	Hydrus Microstent n=138 eyes Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the Hydrus Microstent in one eye (study eye).	iStent n=135 eyes Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the iStent Trabecular Micro Bypass in one eye (study eye)
Percentage of Subjects With Unmedicated DIOP of Not Less Than 5 mmHg and Not More Than 18 mmHg at Month 24	64.5 percentage of subjects	50.4 percentage of subjects

POST_HOC outcome

Timeframe: Baseline, Month 12: 8 am, 12 pm, 4 pm

Population: Intent-to-Treat (ITT) with verifiable data at visit. ITT subjects with secondary glaucoma or pressure lowering procedures, terminal wash-out exemptions, or missed diurnal IOP assessments are counted as failures for response metrics and are assigned a zero value for change in DIOP for the effectiveness endpoints.

Intraocular pressure (IOP) was measured using Goldmann applanation tonometry and averaged over the 8 am, 12 pm, and 4 pm time points. IOP was recorded in millimeters mercury (mmHg). The IOP assessment occurred after a protocol-specified wash-out period from all glaucoma medications.

Outcome measures

Outcome measures
Measure	Hydrus Microstent n=139 eyes Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the Hydrus Microstent in one eye (study eye).	iStent n=141 eyes Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the iStent Trabecular Micro Bypass in one eye (study eye)
Mean Change From Baseline in Unmedicated Mean Diurnal Intraocular Pressure (DIOP) at Month 12	-8.7 mmHg Standard Deviation 4.2	-8.0 mmHg Standard Deviation 4.1

POST_HOC outcome

Timeframe: Baseline, Month 24: 8 am, 12 pm, 4 pm

Population: Intent-to-Treat (ITT) with verifiable data at visit. ITT subjects with secondary glaucoma or pressure lowering procedures, terminal wash-out exemptions, or missed diurnal IOP assessments are counted as failures for response metrics and are assigned a zero value for change in DIOP for the effectiveness endpoints.

Intraocular pressure (IOP) was measured using Goldmann applanation tonometry and averaged over the 8 am, 12 pm, and 4 pm time points. IOP was recorded in millimeters mercury (mmHg). The IOP assessment occurred after a protocol-specified wash-out period from all glaucoma medications.

Outcome measures

Outcome measures
Measure	Hydrus Microstent n=138 eyes Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the Hydrus Microstent in one eye (study eye).	iStent n=135 eyes Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the iStent Trabecular Micro Bypass in one eye (study eye)
Mean Change From Baseline in Unmedicated Mean Diurnal Intraocular Pressure (DIOP) at Month 24	-7.5 mmHg Standard Deviation 4.5	-6.9 mmHg Standard Deviation 4.4

Adverse Events

Hydrus Microstent

Serious events: 2 serious events

Other events: 24 other events

Deaths: 4 deaths

iStent

Serious events: 8 serious events

Other events: 16 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Hydrus Microstent n=154 participants at risk Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the Hydrus Microstent in one eye (the study eye)	iStent n=152 participants at risk Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the iStent Trabecular Micro Bypass in one eye (the study eye)
Eye disorders BCVA loss >/= 2 lines ETDRS >/= 3 months	0.00% 0/154 • Adverse events (AEs) were collected from time of surgery to study exit, approximately 24 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Adverse events as defined in this study protocol include all adverse events (AE) in the study eye. Only study eye adverse events were collected.	0.66% 1/152 • Number of events 1 • Adverse events (AEs) were collected from time of surgery to study exit, approximately 24 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Adverse events as defined in this study protocol include all adverse events (AE) in the study eye. Only study eye adverse events were collected.
Eye disorders Epiretinal Membrane	0.00% 0/154 • Adverse events (AEs) were collected from time of surgery to study exit, approximately 24 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Adverse events as defined in this study protocol include all adverse events (AE) in the study eye. Only study eye adverse events were collected.	0.66% 1/152 • Number of events 1 • Adverse events (AEs) were collected from time of surgery to study exit, approximately 24 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Adverse events as defined in this study protocol include all adverse events (AE) in the study eye. Only study eye adverse events were collected.
Eye disorders IOP Increase	0.00% 0/154 • Adverse events (AEs) were collected from time of surgery to study exit, approximately 24 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Adverse events as defined in this study protocol include all adverse events (AE) in the study eye. Only study eye adverse events were collected.	0.66% 1/152 • Number of events 1 • Adverse events (AEs) were collected from time of surgery to study exit, approximately 24 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Adverse events as defined in this study protocol include all adverse events (AE) in the study eye. Only study eye adverse events were collected.
Eye disorders Uncontrolled Glaucoma	1.3% 2/154 • Number of events 2 • Adverse events (AEs) were collected from time of surgery to study exit, approximately 24 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Adverse events as defined in this study protocol include all adverse events (AE) in the study eye. Only study eye adverse events were collected.	2.6% 4/152 • Number of events 4 • Adverse events (AEs) were collected from time of surgery to study exit, approximately 24 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Adverse events as defined in this study protocol include all adverse events (AE) in the study eye. Only study eye adverse events were collected.
Eye disorders Wet Age-Related Macular Degeneration	0.00% 0/154 • Adverse events (AEs) were collected from time of surgery to study exit, approximately 24 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Adverse events as defined in this study protocol include all adverse events (AE) in the study eye. Only study eye adverse events were collected.	0.66% 1/152 • Number of events 1 • Adverse events (AEs) were collected from time of surgery to study exit, approximately 24 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Adverse events as defined in this study protocol include all adverse events (AE) in the study eye. Only study eye adverse events were collected.

Other adverse events

Other adverse events
Measure	Hydrus Microstent n=154 participants at risk Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the Hydrus Microstent in one eye (the study eye)	iStent n=152 participants at risk Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the iStent Trabecular Micro Bypass in one eye (the study eye)
Eye disorders IOP Increase	3.2% 5/154 • Number of events 5 • Adverse events (AEs) were collected from time of surgery to study exit, approximately 24 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Adverse events as defined in this study protocol include all adverse events (AE) in the study eye. Only study eye adverse events were collected.	6.6% 10/152 • Number of events 11 • Adverse events (AEs) were collected from time of surgery to study exit, approximately 24 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Adverse events as defined in this study protocol include all adverse events (AE) in the study eye. Only study eye adverse events were collected.
Eye disorders Peripheral Anterior Synechia	12.3% 19/154 • Number of events 19 • Adverse events (AEs) were collected from time of surgery to study exit, approximately 24 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Adverse events as defined in this study protocol include all adverse events (AE) in the study eye. Only study eye adverse events were collected.	3.9% 6/152 • Number of events 7 • Adverse events (AEs) were collected from time of surgery to study exit, approximately 24 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Adverse events as defined in this study protocol include all adverse events (AE) in the study eye. Only study eye adverse events were collected.

Additional Information

Director, CDMA Surgical

Alcon Research, LLC

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI agrees that they shall not, without the Sponsor's prior written consent, independently publish, publicly disclose, present or discuss any results of or information pertaining to PI's activities conducted under this Agreement; unless the multi-center manuscript is not submitted for publication within one (1) year after completion of the trial.
Publication restrictions are in place

Restriction type: OTHER