Pigmentary Glaucoma, Primary Open Angle Glaucoma, Pseudoexfoliative Glaucoma
Conditions
Keywords
Primary open angle glaucoma, POAG, Pseudoexfoliative glaucoma, PXG, Pigmentary glaucoma, PG, Hydrus
Brief summary
This clinical trial compares two implantable devices intended to lower the pressure inside the eye of glaucoma patients.
Detailed description
This is a prospective, multicenter, single-masked, randomized clinical trial comparing the Hydrus Microstent to two iStent implants for the reduction of intraocular pressure in phakic patients with a positive diagnosis of primary open angle glaucoma, pseudoexfoliative glaucoma, or pigmentary dispersion glaucoma. Post-operative follow-up visits will be conducted at regular intervals.
Interventions
DEVICEHydrus Microstent
Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.
Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.
Sponsors
Ivantis, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
45 Years to 84 Years
Healthy volunteers
No
Inclusion criteria
* A diagnosis of primary open angle glaucoma (POAG), Pseudoexfoliative (PXG) glaucoma, or Pigmentary glaucoma (PG) * A phakic lens with BCVA of 20/30 or better
Exclusion criteria
* Forms of primary or secondary glaucoma not listed above * Prior glaucoma surgery in the study eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unmedicated IOP </= 19 mmHg at 12 Months | 12 months | Percentage of subjects with IOP \</= 19 mmHg and without the use of ocular hypotensive medications at 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unmedicated IOP </= 18 mmHg at 12 Months | 12 months | Percentage of subjects with IOP \</= 18 mmHg and without the use of ocular hypotensive medications at 12 months |
| The Percentage of Subjects Who Are Not Using Ocular Hypotensive Medications at 12 and 24 Months | 12 & 24 Months | The percentage of subjects who are not using ocular hypotensive medications at 12 and 24 months |
| Mean Medication Use at 12 and 24 Months | 12 & 24 Months | The mean medication use at 12 and 24 months |
| Unmedicated IOP </= 19 mmHg at 24 Months | 24 Months | Percentage of subjects with IOP \</= 19 mmHg and without the use of ocular hypotensive medications at 24 months |
Countries
United States
Participant flow
Recruitment details
Patients were screened and enrolled at 12 investigational sites located outside of the United States
Pre-assignment details
152 patients were randomized
Participants by arm
| Arm | Count |
|---|---|
| Hydrus Microstent Subjects underwent 1 Hydrus implantation | 75 |
| iStent Trabecular Micro Bypass Subjects underwent 2 iStents implantation | 77 |
| Total | 152 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 3 | 1 |
Baseline characteristics
| Characteristic | Hydrus Microstent | iStent Trabecular Micro Bypass | Total |
|---|---|---|---|
| Age, Continuous | 67.5 years STANDARD_DEVIATION 10.3 | 66.5 years STANDARD_DEVIATION 9.5 | 67.0 years STANDARD_DEVIATION 9.9 |
| Race/Ethnicity, Customized Asian | 11 Participants | 11 Participants | 22 Participants |
| Race/Ethnicity, Customized Black or African Descent | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Caucasian/White European | 49 Participants | 49 Participants | 98 Participants |
| Race/Ethnicity, Customized Hispanic/Latino/Central & So American Origin | 14 Participants | 13 Participants | 27 Participants |
| Race/Ethnicity, Customized Native North American | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 41 Participants | 45 Participants | 86 Participants |
| Sex: Female, Male Male | 34 Participants | 32 Participants | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 75 | 1 / 77 |
| other Total, other adverse events | 24 / 75 | 23 / 77 |
| serious Total, serious adverse events | 7 / 75 | 14 / 77 |
Outcome results
Primary
Unmedicated IOP </= 19 mmHg at 12 Months
Percentage of subjects with IOP \</= 19 mmHg and without the use of ocular hypotensive medications at 12 months
Time frame: 12 months
Population: Intent-to-Treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hydrus Microstent | Unmedicated IOP </= 19 mmHg at 12 Months | 34.2 percentage of participants |
| iStent Trabecular Micro Bypass | Unmedicated IOP </= 19 mmHg at 12 Months | 13.3 percentage of participants |
Secondary
Mean Medication Use at 12 and 24 Months
The mean medication use at 12 and 24 months
Time frame: 12 & 24 Months
Population: Intent-to-Treat (ITT). Number of Participants Analyzed at 24 Months in the Hydrus Microstent arm are different than at 12 Months due to patients lost to follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hydrus Microstent | Mean Medication Use at 12 and 24 Months | 12 Months | 0.99 number of medications | Standard Deviation 1.07 |
| Hydrus Microstent | Mean Medication Use at 12 and 24 Months | 24 Months | 1.23 number of medications | Standard Deviation 1.15 |
| iStent Trabecular Micro Bypass | Mean Medication Use at 12 and 24 Months | 12 Months | 1.69 number of medications | Standard Deviation 1.37 |
| iStent Trabecular Micro Bypass | Mean Medication Use at 12 and 24 Months | 24 Months | 1.91 number of medications | Standard Deviation 1.36 |
Secondary
The Percentage of Subjects Who Are Not Using Ocular Hypotensive Medications at 12 and 24 Months
The percentage of subjects who are not using ocular hypotensive medications at 12 and 24 months
Time frame: 12 & 24 Months
Population: Intent-to-Treat (ITT). Number of Participants Analyzed at 24 Months in the Hydrus Microstent arm are different than at 12 Months due to patients lost to follow-up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hydrus Microstent | The Percentage of Subjects Who Are Not Using Ocular Hypotensive Medications at 12 and 24 Months | 24 Months | 38.0 percentage of participants |
| Hydrus Microstent | The Percentage of Subjects Who Are Not Using Ocular Hypotensive Medications at 12 and 24 Months | 12 Months | 46.6 percentage of participants |
| iStent Trabecular Micro Bypass | The Percentage of Subjects Who Are Not Using Ocular Hypotensive Medications at 12 and 24 Months | 12 Months | 24.0 percentage of participants |
| iStent Trabecular Micro Bypass | The Percentage of Subjects Who Are Not Using Ocular Hypotensive Medications at 12 and 24 Months | 24 Months | 18.7 percentage of participants |
Secondary
Unmedicated IOP </= 18 mmHg at 12 Months
Percentage of subjects with IOP \</= 18 mmHg and without the use of ocular hypotensive medications at 12 months
Time frame: 12 months
Population: Intent-to-Treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hydrus Microstent | Unmedicated IOP </= 18 mmHg at 12 Months | 30.1 percentage of participants |
| iStent Trabecular Micro Bypass | Unmedicated IOP </= 18 mmHg at 12 Months | 9.3 percentage of participants |
Secondary
Unmedicated IOP </= 19 mmHg at 24 Months
Percentage of subjects with IOP \</= 19 mmHg and without the use of ocular hypotensive medications at 24 months
Time frame: 24 Months
Population: Intent-to-Treat (ITT). Number of Participants Analyzed at 24Months in the Hydrus Microstent arm are different than at 12 Months due to patients lost to follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hydrus Microstent | Unmedicated IOP </= 19 mmHg at 24 Months | 23.9 percentage of participants |
| iStent Trabecular Micro Bypass | Unmedicated IOP </= 19 mmHg at 24 Months | 13.3 percentage of participants |