Glaucoma
Conditions
Keywords
MIDI Arrow, Glaucoma Drainage Device, GDD, InnFocus, Glaucoma treatment
Brief summary
Assess the safety and performance of the Miami InnFocus Drainage Implant in patients suffering from 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.
Detailed description
Unicentric, non-randomized, single arm safety and performance study which will be conducted in accordance with the applicable parts of CFR 21 and Standard EN-ISO 14155 I & II: 2003 on clinical investigations with medical devices on human subjects and recommendations guiding physicians in biomedical research involving human subjects adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964 and later revisions
Interventions
DEVICEGlaucoma Drainage Device
Insertion of MIDI Arrow subconjunctivally with a fornix-based incision after pretreatment of scleral surface with 0.4 mg/mL MMC and insertion of MIDI Arrow tube through sclera into anterior chamber of eye
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
* Male or female, age 18 to 85 years, inclusive * 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. * Patient must have signed informed consent form
Exclusion criteria
* Unwilling or unable to give informed consent or unable to return for scheduled protocol visits * Pregnant or nursing women * No light perception * Active iris neovascularization or active proliferative retinopathy * Iridocorneal endothelial syndrome * Epithelial or fibrous downgrowth * Aphakia (without pseudophakia) * Vitreous in anterior chamber for which a vitrectomy is anticipated * Chronic or recurrent uveitis * Severe posterior blepharitis * Unwilling to discontinue contact lens use after surgery * Previous ophthalmic surgery, excluding uncomplicated phacoemulsification (cataract) surgery or corneal refractive surgery * Need for glaucoma surgery combined with other ocular procedures other than cataract surgery (i.e., penetrating keratoplasty or retinal surgery) or anticipated need for additional ocular surgery * Known allergy to Mitomycin C (MMC) drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Performance Success | Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60 | Success: IOP \< 15 mmHg or IOP reduced from baseline (pre-operative level) by ≥ 20% (without glaucoma reoperation, such as a trabeculectomy to improve aqueous drainage or implantation of another drainage implant). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maintenance of Pressure Control | Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60 | Maintenance of pressure control throughout the follow-up period, as measured by IOP at each post-operative visit |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time (in Minutes) Taken for the Procedure | Day 1 | The mean surgical procedure time from the time the incision was made in the conjunctiva to the time peritomy closure |
| Visual Acuity | Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60 | Visual acuity measured at each post-operative visit from baseline. |
| Visual Field | 60 Months | Visual field measure at each post op visit. Data not available for summary as per CSR |
| Incidence of Glaucoma Re-operation | 60 Months | Cases requiring glaucoma re-operation |
| Glaucoma Supplemental Medication | Day 1 thru Month 3, Month 6, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60 | The number of glaucoma supplemental medications required after the MicroShunt procedure. |
| Implant Migration | 60 Months | Incidence of implant migration. None reported |
| Implant Encapsulation | 60 Months | Incidence of implant encapsulation. None reported |
| Procedure Feasibility | Day 1 | Defined by ease of insertion of the device into the anterior chamber, based on an Investigator evaluation rating (5-point scale, with 1 being difficult and 5 being easy); |
Countries
Dominican Republic
Participant flow
Recruitment details
This report presents data for 23 patients (Patients 13 to 35), who were implanted with the MicroShunt (one eye implanted per patient)
Participants by arm
| Arm | Count |
|---|---|
| Patient With Primary Open Angle Glaucoma (POAG) Patient with primary open angle glaucoma (POAG) inadequately controlled on tolerated medical therapy with IOP ≥ 18mmHg and ≤ 40 mmHg | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | Patient With Primary Open Angle Glaucoma (POAG) |
|---|---|
| Age, Continuous | 59.8 years |
| Region of Enrollment Dominican Republic | 23 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 23 |
| other Total, other adverse events | 21 / 23 |
| serious Total, serious adverse events | 8 / 23 |
Outcome results
Primary
Number of Participants With Treatment Performance Success
Success: IOP \< 15 mmHg or IOP reduced from baseline (pre-operative level) by ≥ 20% (without glaucoma reoperation, such as a trabeculectomy to improve aqueous drainage or implantation of another drainage implant).
Time frame: Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60
Population: Intention to Treat (ITT) Population: all enrolled patients.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Number of Participants With Treatment Performance Success | Day 1 | 22 Participants |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Number of Participants With Treatment Performance Success | Day 7 | 23 Participants |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Number of Participants With Treatment Performance Success | Week 3 | 23 Participants |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Number of Participants With Treatment Performance Success | Week 6 | 23 Participants |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Number of Participants With Treatment Performance Success | Month 3 | 22 Participants |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Number of Participants With Treatment Performance Success | Month 9 | 23 Participants |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Number of Participants With Treatment Performance Success | Month 12 | 22 Participants |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Number of Participants With Treatment Performance Success | Month 24 | 21 Participants |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Number of Participants With Treatment Performance Success | Month 36 | 20 Participants |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Number of Participants With Treatment Performance Success | Month 48 | 17 Participants |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Number of Participants With Treatment Performance Success | Month 60 | 18 Participants |
Secondary
Maintenance of Pressure Control
Maintenance of pressure control throughout the follow-up period, as measured by IOP at each post-operative visit
Time frame: Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60
Population: Intention to Treat (ITT) Population: all enrolled patients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Maintenance of Pressure Control | Baseline IOP | 23.78 mmHg | Standard Deviation 5.342 |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Maintenance of Pressure Control | Day 1 | 9.6 mmHg | Standard Deviation 5 |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Maintenance of Pressure Control | Day 7 | 7.8 mmHg | Standard Deviation 2.9 |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Maintenance of Pressure Control | Week 3 | 7.4 mmHg | Standard Deviation 2.26 |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Maintenance of Pressure Control | Week 6 | 8.9 mmHg | Standard Deviation 3.81 |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Maintenance of Pressure Control | Month 3 | 10.8 mmHg | Standard Deviation 6.07 |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Maintenance of Pressure Control | Month 6 | 12 mmHg | Standard Deviation 6.17 |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Maintenance of Pressure Control | Month 9 | 11.2 mmHg | Standard Deviation 3.15 |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Maintenance of Pressure Control | Month 12 | 11.3 mmHg | Standard Deviation 4.07 |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Maintenance of Pressure Control | Month 24 | 12 mmHg | Standard Deviation 3.64 |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Maintenance of Pressure Control | Month 36 | 11.8 mmHg | Standard Deviation 6.58 |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Maintenance of Pressure Control | Month 48 | 12 mmHg | Standard Deviation 3.52 |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Maintenance of Pressure Control | Month 60 | 11.5 mmHg | Standard Deviation 4.89 |
Other Pre-specified
Glaucoma Supplemental Medication
The number of glaucoma supplemental medications required after the MicroShunt procedure.
Time frame: Day 1 thru Month 3, Month 6, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60
Population: Intention to Treat (ITT) Population: all enrolled patients.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Glaucoma Supplemental Medication | Month 48 | 0 Medications |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Glaucoma Supplemental Medication | Day 1 thru Month 3 | 0 Medications |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Glaucoma Supplemental Medication | Month 6 | 0 Medications |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Glaucoma Supplemental Medication | Month 9 | 0 Medications |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Glaucoma Supplemental Medication | Baseline | 2 Medications |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Glaucoma Supplemental Medication | Month 12 | 0 Medications |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Glaucoma Supplemental Medication | Month 24 | 0 Medications |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Glaucoma Supplemental Medication | Month 36 | 0 Medications |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Glaucoma Supplemental Medication | Month 60 | 0 Medications |
Other Pre-specified
Implant Encapsulation
Incidence of implant encapsulation. None reported
Time frame: 60 Months
Other Pre-specified
Implant Migration
Incidence of implant migration. None reported
Time frame: 60 Months
Other Pre-specified
Incidence of Glaucoma Re-operation
Cases requiring glaucoma re-operation
Time frame: 60 Months
Population: Intention to Treat (ITT) Population: all enrolled patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Incidence of Glaucoma Re-operation | 2 participants |
Other Pre-specified
Procedure Feasibility
Defined by ease of insertion of the device into the anterior chamber, based on an Investigator evaluation rating (5-point scale, with 1 being difficult and 5 being easy);
Time frame: Day 1
Population: Intention to Treat (ITT) Population: all enrolled patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Procedure Feasibility | 5 - Easy | 17 Participants |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Procedure Feasibility | 1 - Difficult | 0 Participants |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Procedure Feasibility | 2 | 0 Participants |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Procedure Feasibility | 3 | 0 Participants |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Procedure Feasibility | 4 | 6 Participants |
Other Pre-specified
Time (in Minutes) Taken for the Procedure
The mean surgical procedure time from the time the incision was made in the conjunctiva to the time peritomy closure
Time frame: Day 1
Population: Intention to Treat (ITT) Population: all enrolled patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Time (in Minutes) Taken for the Procedure | 25.3 Minutes | Standard Deviation 7.82 |
Other Pre-specified
Visual Acuity
Visual acuity measured at each post-operative visit from baseline.
Time frame: Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60
Population: Intention to Treat (ITT) Population: all enrolled patients.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Visual Acuity | Month 12 | .79 LogMar | Standard Deviation 1.113 |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Visual Acuity | Month 6 | .85 LogMar | Standard Deviation 1.211 |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Visual Acuity | Month 9 | .85 LogMar | Standard Deviation 1.176 |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Visual Acuity | Month 24 | .90 LogMar | Standard Deviation 1.151 |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Visual Acuity | Month 36 | .69 LogMar | Standard Deviation 0.992 |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Visual Acuity | Month 48 | .44 LogMar | Standard Deviation 0.741 |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Visual Acuity | Month 60 | .43 LogMar | Standard Deviation 0.909 |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Visual Acuity | Baseline | .94 LogMar | Standard Deviation 1.143 |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Visual Acuity | Day 1 | 1.28 LogMar | Standard Deviation 1.203 |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Visual Acuity | Day7 | .99 LogMar | Standard Deviation 1.023 |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Visual Acuity | Week 3 | .87 LogMar | Standard Deviation 0.991 |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Visual Acuity | Week 6 | .76 LogMar | Standard Deviation 1.031 |
| To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma | Visual Acuity | Month 3 | .92 LogMar | Standard Deviation 1.226 |
Other Pre-specified
Visual Field
Visual field measure at each post op visit. Data not available for summary as per CSR
Time frame: 60 Months