Trial Outcomes & Findings for Clinical Study of the Safety and Performance of the Miami InnFocus Drainage Implant to Relieve Glaucoma Symptoms (NCT NCT00772330)
NCT ID: NCT00772330
Last Updated: 2021-07-14
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60
Results posted on
2021-07-14
Participant Flow
This report presents data for 23 patients (Patients 13 to 35), who were implanted with the MicroShunt (one eye implanted per patient)
Participant milestones
| Measure |
MIDI Arrow
Eligible patients with POAG were implanted with a MicroShunt in the anterior chamber of the eye
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
MIDI Arrow
Eligible patients with POAG were implanted with a MicroShunt in the anterior chamber of the eye
|
|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
Baseline Characteristics
Clinical Study of the Safety and Performance of the Miami InnFocus Drainage Implant to Relieve Glaucoma Symptoms
Baseline characteristics by cohort
| Measure |
Patient With Primary Open Angle Glaucoma (POAG)
n=23 Participants
Patient with primary open angle glaucoma (POAG) inadequately controlled on tolerated medical therapy with IOP ≥ 18mmHg and ≤ 40 mmHg
|
|---|---|
|
Age, Continuous
|
59.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
Dominican Republic
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60Population: Intention to Treat (ITT) Population: all enrolled patients.
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).
Outcome measures
| Measure |
To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma
n=23 Participants
To Assess safety and performance of the MIDI arrow in patients suffering from Glaucoma inadequately controlled on medical therapy with IOP \>/= 18mmHg and \</= 40mmHg
|
|---|---|
|
Number of Participants With Treatment Performance Success
Day 1
|
22 Participants
|
|
Number of Participants With Treatment Performance Success
Month 24
|
21 Participants
|
|
Number of Participants With Treatment Performance Success
Month 36
|
20 Participants
|
|
Number of Participants With Treatment Performance Success
Month 48
|
17 Participants
|
|
Number of Participants With Treatment Performance Success
Month 60
|
18 Participants
|
|
Number of Participants With Treatment Performance Success
Day 7
|
23 Participants
|
|
Number of Participants With Treatment Performance Success
Week 3
|
23 Participants
|
|
Number of Participants With Treatment Performance Success
Week 6
|
23 Participants
|
|
Number of Participants With Treatment Performance Success
Month 3
|
22 Participants
|
|
Number of Participants With Treatment Performance Success
Month 9
|
23 Participants
|
|
Number of Participants With Treatment Performance Success
Month 12
|
22 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60Population: Intention to Treat (ITT) Population: all enrolled patients
Maintenance of pressure control throughout the follow-up period, as measured by IOP at each post-operative visit
Outcome measures
| Measure |
To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma
n=23 Participants
To Assess safety and performance of the MIDI arrow in patients suffering from Glaucoma inadequately controlled on medical therapy with IOP \>/= 18mmHg and \</= 40mmHg
|
|---|---|
|
Maintenance of Pressure Control
Day 7
|
7.8 mmHg
Standard Deviation 2.9
|
|
Maintenance of Pressure Control
Baseline IOP
|
23.78 mmHg
Standard Deviation 5.342
|
|
Maintenance of Pressure Control
Day 1
|
9.6 mmHg
Standard Deviation 5
|
|
Maintenance of Pressure Control
Week 3
|
7.4 mmHg
Standard Deviation 2.26
|
|
Maintenance of Pressure Control
Week 6
|
8.9 mmHg
Standard Deviation 3.81
|
|
Maintenance of Pressure Control
Month 3
|
10.8 mmHg
Standard Deviation 6.07
|
|
Maintenance of Pressure Control
Month 6
|
12 mmHg
Standard Deviation 6.17
|
|
Maintenance of Pressure Control
Month 9
|
11.2 mmHg
Standard Deviation 3.15
|
|
Maintenance of Pressure Control
Month 12
|
11.3 mmHg
Standard Deviation 4.07
|
|
Maintenance of Pressure Control
Month 24
|
12 mmHg
Standard Deviation 3.64
|
|
Maintenance of Pressure Control
Month 36
|
11.8 mmHg
Standard Deviation 6.58
|
|
Maintenance of Pressure Control
Month 48
|
12 mmHg
Standard Deviation 3.52
|
|
Maintenance of Pressure Control
Month 60
|
11.5 mmHg
Standard Deviation 4.89
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1Population: Intention to Treat (ITT) Population: all enrolled patients.
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);
Outcome measures
| Measure |
To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma
n=23 Participants
To Assess safety and performance of the MIDI arrow in patients suffering from Glaucoma inadequately controlled on medical therapy with IOP \>/= 18mmHg and \</= 40mmHg
|
|---|---|
|
Procedure Feasibility
1 - Difficult
|
0 Participants
|
|
Procedure Feasibility
2
|
0 Participants
|
|
Procedure Feasibility
3
|
0 Participants
|
|
Procedure Feasibility
4
|
6 Participants
|
|
Procedure Feasibility
5 - Easy
|
17 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1Population: Intention to Treat (ITT) Population: all enrolled patients.
The mean surgical procedure time from the time the incision was made in the conjunctiva to the time peritomy closure
Outcome measures
| Measure |
To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma
n=23 Participants
To Assess safety and performance of the MIDI arrow in patients suffering from Glaucoma inadequately controlled on medical therapy with IOP \>/= 18mmHg and \</= 40mmHg
|
|---|---|
|
Time (in Minutes) Taken for the Procedure
|
25.3 Minutes
Standard Deviation 7.82
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60Population: Intention to Treat (ITT) Population: all enrolled patients.
Visual acuity measured at each post-operative visit from baseline.
Outcome measures
| Measure |
To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma
n=22 Participants
To Assess safety and performance of the MIDI arrow in patients suffering from Glaucoma inadequately controlled on medical therapy with IOP \>/= 18mmHg and \</= 40mmHg
|
|---|---|
|
Visual Acuity
Baseline
|
.94 LogMar
Standard Deviation 1.143
|
|
Visual Acuity
Day 1
|
1.28 LogMar
Standard Deviation 1.203
|
|
Visual Acuity
Day7
|
.99 LogMar
Standard Deviation 1.023
|
|
Visual Acuity
Week 3
|
.87 LogMar
Standard Deviation .991
|
|
Visual Acuity
Week 6
|
.76 LogMar
Standard Deviation 1.031
|
|
Visual Acuity
Month 3
|
.92 LogMar
Standard Deviation 1.226
|
|
Visual Acuity
Month 6
|
.85 LogMar
Standard Deviation 1.211
|
|
Visual Acuity
Month 9
|
.85 LogMar
Standard Deviation 1.176
|
|
Visual Acuity
Month 12
|
.79 LogMar
Standard Deviation 1.113
|
|
Visual Acuity
Month 24
|
.90 LogMar
Standard Deviation 1.151
|
|
Visual Acuity
Month 36
|
.69 LogMar
Standard Deviation .992
|
|
Visual Acuity
Month 48
|
.44 LogMar
Standard Deviation .741
|
|
Visual Acuity
Month 60
|
.43 LogMar
Standard Deviation .909
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 60 MonthsVisual field measure at each post op visit. Data not available for summary as per CSR
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 60 MonthsPopulation: Intention to Treat (ITT) Population: all enrolled patients.
Cases requiring glaucoma re-operation
Outcome measures
| Measure |
To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma
n=23 Participants
To Assess safety and performance of the MIDI arrow in patients suffering from Glaucoma inadequately controlled on medical therapy with IOP \>/= 18mmHg and \</= 40mmHg
|
|---|---|
|
Incidence of Glaucoma Re-operation
|
2 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 thru Month 3, Month 6, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60Population: Intention to Treat (ITT) Population: all enrolled patients.
The number of glaucoma supplemental medications required after the MicroShunt procedure.
Outcome measures
| Measure |
To Assess Safety and Performance of the MIDI Arrow in Patients w Glaucoma
n=23 Participants
To Assess safety and performance of the MIDI arrow in patients suffering from Glaucoma inadequately controlled on medical therapy with IOP \>/= 18mmHg and \</= 40mmHg
|
|---|---|
|
Glaucoma Supplemental Medication
Baseline
|
2 Medications
Interval 1.0 to 4.0
|
|
Glaucoma Supplemental Medication
Day 1 thru Month 3
|
0 Medications
Interval 0.0 to 0.0
|
|
Glaucoma Supplemental Medication
Month 6
|
0 Medications
Interval 0.0 to 2.0
|
|
Glaucoma Supplemental Medication
Month 9
|
0 Medications
Interval 0.0 to 2.0
|
|
Glaucoma Supplemental Medication
Month 12
|
0 Medications
Interval 0.0 to 3.0
|
|
Glaucoma Supplemental Medication
Month 24
|
0 Medications
Interval 0.0 to 3.0
|
|
Glaucoma Supplemental Medication
Month 36
|
0 Medications
Interval 0.0 to 4.0
|
|
Glaucoma Supplemental Medication
Month 48
|
0 Medications
Interval 0.0 to 3.0
|
|
Glaucoma Supplemental Medication
Month 60
|
0 Medications
Interval 0.0 to 4.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 60 MonthsIncidence of implant migration. None reported
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 60 MonthsIncidence of implant encapsulation. None reported
Outcome measures
Outcome data not reported
Adverse Events
Patient With Primary Open Angle Glaucoma (POAG)
Serious events: 8 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patient With Primary Open Angle Glaucoma (POAG)
n=23 participants at risk
Patient with primary open angle glaucoma (POAG) inadequately controlled on tolerated medical therapy with IOP ≥ 18mmHg and ≤ 40 mmHg
|
|---|---|
|
Eye disorders
Posterior capsule opacification
|
8.7%
2/23 • Number of events 2 • Adverse events (AEs) were reported up to 60 months of follow up.
Any untoward medical occurrence in a subject
|
|
Investigations
Intraocular pressure increased
|
17.4%
4/23 • Number of events 6 • Adverse events (AEs) were reported up to 60 months of follow up.
Any untoward medical occurrence in a subject
|
|
Injury, poisoning and procedural complications
Eye operation complication
|
4.3%
1/23 • Number of events 1 • Adverse events (AEs) were reported up to 60 months of follow up.
Any untoward medical occurrence in a subject
|
|
Eye disorders
Iris adhesions
|
4.3%
1/23 • Number of events 1 • Adverse events (AEs) were reported up to 60 months of follow up.
Any untoward medical occurrence in a subject
|
|
Injury, poisoning and procedural complications
Tenon's cyst
|
4.3%
1/23 • Number of events 1 • Adverse events (AEs) were reported up to 60 months of follow up.
Any untoward medical occurrence in a subject
|
|
Eye disorders
Cataract
|
8.7%
2/23 • Number of events 2 • Adverse events (AEs) were reported up to 60 months of follow up.
Any untoward medical occurrence in a subject
|
|
Eye disorders
Malignant Glaucoma
|
4.3%
1/23 • Number of events 1 • Adverse events (AEs) were reported up to 60 months of follow up.
Any untoward medical occurrence in a subject
|
|
Cardiac disorders
Angina
|
4.3%
1/23 • Number of events 1 • Adverse events (AEs) were reported up to 60 months of follow up.
Any untoward medical occurrence in a subject
|
Other adverse events
| Measure |
Patient With Primary Open Angle Glaucoma (POAG)
n=23 participants at risk
Patient with primary open angle glaucoma (POAG) inadequately controlled on tolerated medical therapy with IOP ≥ 18mmHg and ≤ 40 mmHg
|
|---|---|
|
Eye disorders
Anterior chamber inflammation
|
4.3%
1/23 • Number of events 11 • Adverse events (AEs) were reported up to 60 months of follow up.
Any untoward medical occurrence in a subject
|
|
Eye disorders
Choroidal effusion
|
8.7%
2/23 • Number of events 2 • Adverse events (AEs) were reported up to 60 months of follow up.
Any untoward medical occurrence in a subject
|
|
Eye disorders
Conjunctival bleb
|
8.7%
2/23 • Number of events 3 • Adverse events (AEs) were reported up to 60 months of follow up.
Any untoward medical occurrence in a subject
|
|
Eye disorders
Conjunctival hyperaemia
|
4.3%
1/23 • Number of events 1 • Adverse events (AEs) were reported up to 60 months of follow up.
Any untoward medical occurrence in a subject
|
|
Eye disorders
Corneal oedema
|
21.7%
5/23 • Number of events 5 • Adverse events (AEs) were reported up to 60 months of follow up.
Any untoward medical occurrence in a subject
|
|
Eye disorders
Corneal striae
|
8.7%
2/23 • Number of events 2 • Adverse events (AEs) were reported up to 60 months of follow up.
Any untoward medical occurrence in a subject
|
|
Eye disorders
Dry eye
|
4.3%
1/23 • Number of events 1 • Adverse events (AEs) were reported up to 60 months of follow up.
Any untoward medical occurrence in a subject
|
|
Eye disorders
Eye pain
|
17.4%
4/23 • Number of events 5 • Adverse events (AEs) were reported up to 60 months of follow up.
Any untoward medical occurrence in a subject
|
|
Eye disorders
Flat anterior chamber of eye
|
13.0%
3/23 • Number of events 3 • Adverse events (AEs) were reported up to 60 months of follow up.
Any untoward medical occurrence in a subject
|
|
Eye disorders
Hypotony of eye
|
17.4%
4/23 • Number of events 4 • Adverse events (AEs) were reported up to 60 months of follow up.
Any untoward medical occurrence in a subject
|
|
Eye disorders
Iris adhesions
|
8.7%
2/23 • Number of events 2 • Adverse events (AEs) were reported up to 60 months of follow up.
Any untoward medical occurrence in a subject
|
|
Eye disorders
Lacrimation increased
|
8.7%
2/23 • Number of events 2 • Adverse events (AEs) were reported up to 60 months of follow up.
Any untoward medical occurrence in a subject
|
|
Eye disorders
Meibomianitis
|
4.3%
1/23 • Number of events 1 • Adverse events (AEs) were reported up to 60 months of follow up.
Any untoward medical occurrence in a subject
|
|
Eye disorders
Posterior capsule opacification
|
13.0%
3/23 • Number of events 3 • Adverse events (AEs) were reported up to 60 months of follow up.
Any untoward medical occurrence in a subject
|
|
Eye disorders
Vitreous haemorrhage
|
4.3%
1/23 • Number of events 1 • Adverse events (AEs) were reported up to 60 months of follow up.
Any untoward medical occurrence in a subject
|
|
Injury, poisoning and procedural complications
Conjunctival filtering bleb leak
|
4.3%
1/23 • Number of events 1 • Adverse events (AEs) were reported up to 60 months of follow up.
Any untoward medical occurrence in a subject
|
|
Injury, poisoning and procedural complications
Eye operation complication
|
17.4%
4/23 • Number of events 4 • Adverse events (AEs) were reported up to 60 months of follow up.
Any untoward medical occurrence in a subject
|
|
Injury, poisoning and procedural complications
Hyphaema
|
13.0%
3/23 • Number of events 3 • Adverse events (AEs) were reported up to 60 months of follow up.
Any untoward medical occurrence in a subject
|
|
Injury, poisoning and procedural complications
Ocular procedural complication
|
4.3%
1/23 • Number of events 1 • Adverse events (AEs) were reported up to 60 months of follow up.
Any untoward medical occurrence in a subject
|
|
Injury, poisoning and procedural complications
Tenon's cyst
|
8.7%
2/23 • Number of events 2 • Adverse events (AEs) were reported up to 60 months of follow up.
Any untoward medical occurrence in a subject
|
|
Investigations
Intraocular pressure increased
|
26.1%
6/23 • Number of events 11 • Adverse events (AEs) were reported up to 60 months of follow up.
Any untoward medical occurrence in a subject
|
|
Nervous system disorders
Visual field defect
|
4.3%
1/23 • Number of events 1 • Adverse events (AEs) were reported up to 60 months of follow up.
Any untoward medical occurrence in a subject
|
|
Product Issues
Device deployment issue
|
13.0%
3/23 • Number of events 3 • Adverse events (AEs) were reported up to 60 months of follow up.
Any untoward medical occurrence in a subject
|
|
Product Issues
Device occlusion
|
4.3%
1/23 • Number of events 1 • Adverse events (AEs) were reported up to 60 months of follow up.
Any untoward medical occurrence in a subject
|
Additional Information
Sharon Herbert, Associate Director of Clinical Operations
InnFocus, Inc.
Phone: (415) 268-9059
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place