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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MIDI Arrow | Experimental | Ab externo glaucoma drainage device with no reservoir |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glaucoma Drainage Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance of Pressure Control | Maintenance of pressure control throughout the follow-up period, as measured by IOP at each post-operative visit | Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60 |
| Measure | Description | Time Frame |
|---|---|---|
| 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); | Day 1 |
| Time (in Minutes) Taken for the Procedure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan F Batlle, MD | Laser Center, Santo Domingo, Dominican Republic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laser Center | Santo Domingo | Dominican Republic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40408035 | Derived | Garcia-Feijoo J, Batlle JF, Aptel F, Lachkar Y, Riss I, Sadruddin O, Nguyen T, Beckers HJM. Pooled Analysis of Three MicroShunt Studies in Primary Open-Angle Glaucoma Evaluating Different Concentrations of Applied Mitomycin C. Ophthalmol Ther. 2025 Jul;14(7):1533-1549. doi: 10.1007/s40123-025-01149-4. Epub 2025 May 23. | |
| 33137019 |
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This report presents data for 23 patients (Patients 13 to 35), who were implanted with the MicroShunt (one eye implanted per patient)
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| ID | Title | Description |
|---|---|---|
| FG000 | MIDI Arrow | Eligible patients with POAG were implanted with a MicroShunt in the anterior chamber of the eye |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Intention to Treat (ITT) Population: all enrolled patients.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Intention to Treat (ITT) Population: all enrolled patients. | Posted | Count of Participants | Participants | Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60 |
|
Adverse events (AEs) were reported up to 60 months of follow up.
Any untoward medical occurrence in a subject
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Posterior capsule opacification | Eye disorders | MedDRA Coding | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anterior chamber inflammation | Eye disorders | MedDRA Coding | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sharon Herbert, Associate Director of Clinical Operations | InnFocus, Inc. | (415) 268-9059 | sharon.herbert@santen.com |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D020327 | Glaucoma Drainage Implants |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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The mean surgical procedure time from the time the incision was made in the conjunctiva to the time peritomy closure
| Day 1 |
| Visual Acuity | Visual acuity measured at each post-operative visit from baseline. | Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60 |
| Visual Field | Visual field measure at each post op visit. Data not available for summary as per CSR | 60 Months |
| Incidence of Glaucoma Re-operation | Cases requiring glaucoma re-operation | 60 Months |
| Glaucoma Supplemental Medication | The number of glaucoma supplemental medications required after the MicroShunt procedure. | Day 1 thru Month 3, Month 6, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60 |
| Implant Migration | Incidence of implant migration. None reported | 60 Months |
| Implant Encapsulation | Incidence of implant encapsulation. None reported | 60 Months |
| Batlle JF, Corona A, Albuquerque R. Long-term Results of the PRESERFLO MicroShunt in Patients With Primary Open-angle Glaucoma From a Single-center Nonrandomized Study. J Glaucoma. 2021 Mar 1;30(3):281-286. doi: 10.1097/IJG.0000000000001734. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Maintenance of Pressure Control | Maintenance of pressure control throughout the follow-up period, as measured by IOP at each post-operative visit | Intention to Treat (ITT) Population: all enrolled patients | Posted | Mean | Standard Deviation | mmHg | Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60 |
|
|
|
| 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); | Intention to Treat (ITT) Population: all enrolled patients. | Posted | Number | Participants | Day 1 |
|
|
|
| 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 | Intention to Treat (ITT) Population: all enrolled patients. | Posted | Mean | Standard Deviation | Minutes | Day 1 |
|
|
|
| Other Pre-specified | Visual Acuity | Visual acuity measured at each post-operative visit from baseline. | Intention to Treat (ITT) Population: all enrolled patients. | Posted | Mean | Standard Deviation | LogMar | Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60 |
|
|
|
| Other Pre-specified | Visual Field | Visual field measure at each post op visit. Data not available for summary as per CSR | Not Posted | 60 Months | Participants |
| Other Pre-specified | Incidence of Glaucoma Re-operation | Cases requiring glaucoma re-operation | Intention to Treat (ITT) Population: all enrolled patients. | Posted | Number | participants | 60 Months |
|
|
|
| Other Pre-specified | Glaucoma Supplemental Medication | The number of glaucoma supplemental medications required after the MicroShunt procedure. | Intention to Treat (ITT) Population: all enrolled patients. | Posted | Median | Full Range | Medications | Day 1 thru Month 3, Month 6, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60 |
|
|
|
| Other Pre-specified | Implant Migration | Incidence of implant migration. None reported | Not Posted | 60 Months | Participants |
| Other Pre-specified | Implant Encapsulation | Incidence of implant encapsulation. None reported | Not Posted | 60 Months | Participants |
| 0 |
| 23 |
| 8 |
| 23 |
| 21 |
| 23 |
| Intraocular pressure increased | Investigations | MedDRA Coding v19.0 | Systematic Assessment |
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| Eye operation complication | Injury, poisoning and procedural complications | MedDRA Coding v19.0 | Systematic Assessment |
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| Iris adhesions | Eye disorders | MedDRA Coding v19.0 | Systematic Assessment |
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| Tenon's cyst | Injury, poisoning and procedural complications | MedDRA Coding v19.0 | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA Coding v19.0 | Systematic Assessment |
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| Malignant Glaucoma | Eye disorders | MedDRA Coding v19.0 | Systematic Assessment |
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| Angina | Cardiac disorders | MedDRA Coding v19.0 | Systematic Assessment |
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| Choroidal effusion | Eye disorders | MedDRA Coding v19.0 | Systematic Assessment |
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| Conjunctival bleb | Eye disorders | MedDRA Coding v19.0 | Systematic Assessment |
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| Conjunctival hyperaemia | Eye disorders | MedDRA Coding v19.0 | Systematic Assessment |
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| Corneal oedema | Eye disorders | MedDRA Coding v19.0 | Systematic Assessment |
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| Corneal striae | Eye disorders | MedDRA Coding v19.0 | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA Coding v19.0 | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA Coding v19.0 | Systematic Assessment |
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| Flat anterior chamber of eye | Eye disorders | MedDRA Coding v19.0 | Systematic Assessment |
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| Hypotony of eye | Eye disorders | MedDRA Coding v19.0 | Systematic Assessment |
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| Iris adhesions | Eye disorders | MedDRA Coding v19.0 | Systematic Assessment |
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| Lacrimation increased | Eye disorders | MedDRA Coding v19.0 | Systematic Assessment |
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| Meibomianitis | Eye disorders | MedDRA Coding v19.0 | Systematic Assessment |
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| Posterior capsule opacification | Eye disorders | MedDRA Coding v19.0 | Systematic Assessment |
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| Vitreous haemorrhage | Eye disorders | MedDRA Coding v19.0 | Systematic Assessment |
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| Conjunctival filtering bleb leak | Injury, poisoning and procedural complications | MedDRA Coding v19.0 | Systematic Assessment |
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| Eye operation complication | Injury, poisoning and procedural complications | MedDRA Coding v19.0 | Systematic Assessment |
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| Hyphaema | Injury, poisoning and procedural complications | MedDRA Coding v19.0 | Systematic Assessment |
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| Ocular procedural complication | Injury, poisoning and procedural complications | MedDRA Coding v19.0 | Systematic Assessment |
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| Tenon's cyst | Injury, poisoning and procedural complications | MedDRA Coding v19.0 | Systematic Assessment |
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| Intraocular pressure increased | Investigations | MedDRA Coding v19.0 | Systematic Assessment |
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| Visual field defect | Nervous system disorders | MedDRA Coding v19.0 | Systematic Assessment |
|
| Device deployment issue | Product Issues | MedDRA Coding v19.0 | Systematic Assessment |
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| Device occlusion | Product Issues | MedDRA Coding v19.0 | Systematic Assessment |
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