Primary Open Angle Glaucoma
Conditions
Brief summary
To assess the safety and performance of the MIDI Arrow in patients suffering from glaucoma that is inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 40 mm Hg
Detailed description
This will be a monocentric, non-randomized, single arm clinical study in which each patient meeting the inclusion criteria and not excluded per the exclusion criteria will be implanted with a MIDI Arrow in the anterior chamber of the eye. Patients will be followed for at least 24 months with an expected enrollment period of up to 24 months. Safety of the shunt will be evaluated with indirect and direct microscopic evaluation of the implanted and non-implanted eyes pre and post operatively, and at defined follow-up intervals for hypotony, inflammation, infection, migration of the shunt, visual acuity, as well as a number of other defined potential complications. The effectiveness of the shunt will be evaluated by measurement of intraocular pressure at defined intervals.
Interventions
DEVICEMIDI Arrow
Implantation of MIDI Arrow
Sponsors
InnFocus Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female patient, age 18 to 85 years, inclusive 2. Patient has primary open angle glaucoma that is inadequately controlled on tolerated medical therapy with intraocular pressure greater than or equal to 18 mm Hg and less than or equal to 40 mm Hg 3. Patient must have signed and dated the Informed Consent form
Exclusion criteria
1. Unwilling or unable to give informed consent or unable to return for scheduled protocol visits. 2. Pregnant or nursing women. 3. No light perception. 4. Active iris neovascularization or active proliferative retinopathy. 5. Iridocorneal endothelial syndrome. 6. Epithelial or fibrous downgrowth. 7. Pseudoexfoliative glaucoma 8. Aphakia. 9. Vitreous in anterior chamber for which a vitrectomy is anticipated. 10. Corneal disease 11. Acute, chronic or recurrent uveitis. 12. Severe posterior blepharitis. 13. Unwilling to discontinue contact lens use after surgery. 14. Previous ophthalmic surgery, excluding phacoemulsification (cataract) surgery or corneal refractive surgery. 15. Prior cataract surgery involving a conjunctival incision 16. Need for glaucoma surgery combined with other ocular procedures except for cataract surgery or anticipated need for additional ocular surgery during the investigational period. 17. Less than 0.1 (20/200) visual acuity in the non-test eye. 18. Infectious conjunctivitis, a narrow-angle glaucoma, endophthalmitis, orbital cellulitis one, infection, severe dry eye, severe myopia, conjunctivitis fine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Eyes With Study Success | Months 6, 9, 12 and 24 | The rate of success reflected sustained control of IOP over 24 Months from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IOP Change From Baseline | At Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12 and Month 24 | Intraocular Pressure (IOP) change in studied eye compared to baseline value at all timepoints thru 24 Months. |
Countries
France
Participant flow
Recruitment details
Listing of Eyes under Study
Participants by arm
| Arm | Count |
|---|---|
| MIDI Arrow Implantation of MIDI Arrow (MicroShunt) in the anterior chamber of the eye in patients with primary open angle glaucoma (POAG) | 67 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 6 | 0 |
| Overall Study | Medical Reasons | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | MIDI Arrow |
|---|---|
| Age, Continuous | 64.1 years STANDARD_DEVIATION 13.1 |
| Region of Enrollment France | 67 Participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 74 |
| other Total, other adverse events | 68 / 74 |
| serious Total, serious adverse events | 10 / 74 |
Outcome results
Primary
Number of Eyes With Study Success
The rate of success reflected sustained control of IOP over 24 Months from baseline
Time frame: Months 6, 9, 12 and 24
Population: The Intent-to-Treat (ITT) population included all enrolled eyes who have signed the informed consent and attended the procedure visit to receive the assigned therapy under evaluation (MIDI Arrow).
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Success With Respect to IOP | Number of Eyes With Study Success | Month 6 | 50 Implanted eyes |
| Success With Respect to IOP | Number of Eyes With Study Success | Month 9 | 52 Implanted eyes |
| Success With Respect to IOP | Number of Eyes With Study Success | Month 12 | 50 Implanted eyes |
| Success With Respect to IOP | Number of Eyes With Study Success | Month 24 | 51 Implanted eyes |
Secondary
IOP Change From Baseline
Intraocular Pressure (IOP) change in studied eye compared to baseline value at all timepoints thru 24 Months.
Time frame: At Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12 and Month 24
Population: The Intent-to-Treat (ITT) population included all enrolled subject who have signed the informed consent and attended the procedure visit to receive the assigned therapy under evaluation (MIDI Arrow).~IOP data collected after glaucoma re-operation was censored for this analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Success With Respect to IOP | IOP Change From Baseline | IOP at Baseline | 26 mmHg | Standard Deviation 7 |
| Success With Respect to IOP | IOP Change From Baseline | Day 1 | 9.2 mmHg | Standard Deviation 4.2 |
| Success With Respect to IOP | IOP Change From Baseline | Day 7 | 10.9 mmHg | Standard Deviation 5.2 |
| Success With Respect to IOP | IOP Change From Baseline | Week 3 | 13.2 mmHg | Standard Deviation 6.3 |
| Success With Respect to IOP | IOP Change From Baseline | Week 6 | 13.3 mmHg | Standard Deviation 5.2 |
| Success With Respect to IOP | IOP Change From Baseline | Month 3 | 13.8 mmHg | Standard Deviation 4.1 |
| Success With Respect to IOP | IOP Change From Baseline | Month 6 | 15 mmHg | Standard Deviation 3.9 |
| Success With Respect to IOP | IOP Change From Baseline | Month 9 | 15.4 mmHg | Standard Deviation 4.2 |
| Success With Respect to IOP | IOP Change From Baseline | Month 12 | 15.6 mmHg | Standard Deviation 4.7 |
| Success With Respect to IOP | IOP Change From Baseline | Month 24 | 16.2 mmHg | Standard Deviation 5.8 |