Trial Outcomes & Findings for Post Market Study of the InnFocus MicroShunt (NCT NCT02177123)
NCT ID: NCT02177123
Last Updated: 2021-06-24
Results Overview
Rate of success with respect to IOP at Months 6, 9, 12 and 24 on ITT population
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
107 participants
Primary outcome timeframe
Month 6, 9, 12, and 24
Results posted on
2021-06-24
Participant Flow
Participant milestones
| Measure |
Subjects Suffering From Primary Open Angle Glaucoma
Subjects suffering from primary open angle glaucoma who are inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 35 mm Hg and/or.where glaucoma progression warrants surgery
|
|---|---|
|
Overall Study
STARTED
|
107
|
|
Overall Study
COMPLETED
|
83
|
|
Overall Study
NOT COMPLETED
|
24
|
Reasons for withdrawal
| Measure |
Subjects Suffering From Primary Open Angle Glaucoma
Subjects suffering from primary open angle glaucoma who are inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 35 mm Hg and/or.where glaucoma progression warrants surgery
|
|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Excluded by Sponsor - other reason
|
2
|
|
Overall Study
Excluded for medical reasons
|
2
|
|
Overall Study
Death
|
1
|
|
Overall Study
Other
|
1
|
|
Overall Study
Excl. #31 Ocular pathology or medical condition which would place subject at increased risk
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Subjects Suffering From Primary Open Angle Glaucoma
n=101 Participants
Subjects suffering from primary open angle glaucoma who are inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 35 mm Hg and/or.where glaucoma progression warrants surgery.
|
|---|---|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 12.6 • n=101 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=101 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=101 Participants
|
|
Region of Enrollment
France
|
65 Participants
n=101 Participants
|
|
Region of Enrollment
Switzerland
|
8 Participants
n=101 Participants
|
|
Region of Enrollment
Netherlands
|
12 Participants
n=101 Participants
|
|
Region of Enrollment
Spain
|
16 Participants
n=101 Participants
|
PRIMARY outcome
Timeframe: Month 6, 9, 12, and 24Population: The Intent-to-Treat (ITT) population included all patients who have signed the informed consent and received the assigned therapy under evaluation (InnFocus MicroShunt).
Rate of success with respect to IOP at Months 6, 9, 12 and 24 on ITT population
Outcome measures
| Measure |
Success With Respect for IOP
n=101 Participants
The rates of success reflected sustained control of IOP
|
Need for Glaucoma Supplemental Treatment at M24
Patients Taking Glaucoma Supplemental Treatment (Study Eye)
|
|---|---|---|
|
Number of Participants With Study Success
Month 6
|
62 Participants
|
—
|
|
Number of Participants With Study Success
Month 9
|
59 Participants
|
—
|
|
Number of Participants With Study Success
Month 12
|
58 Participants
|
—
|
|
Number of Participants With Study Success
Month 24
|
60 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 7, Week 4, Month 3, Month 6, Month 9, Month 12, and Month 24Population: The Intent-to-Treat (ITT) population included all patients who have signed the informed consent and received the assigned therapy under evaluation (InnFocus MicroShunt). IOP data collected after glaucoma re-operation was censored for this analysis.
IOP relative to the pre-operative value was assessed at each post-operative visit (Day 1, Day 7, Week 4, Month 3, Month 6, Month 9, Month 12, and Month 24).
Outcome measures
| Measure |
Success With Respect for IOP
n=101 Participants
The rates of success reflected sustained control of IOP
|
Need for Glaucoma Supplemental Treatment at M24
Patients Taking Glaucoma Supplemental Treatment (Study Eye)
|
|---|---|---|
|
IOP Change
Baseline
|
21.5 mmHg
Standard Deviation 4.2
|
—
|
|
IOP Change
Day 1
|
9.5 mmHg
Standard Deviation 2.9
|
—
|
|
IOP Change
Day 7
|
9.8 mmHg
Standard Deviation 3.5
|
—
|
|
IOP Change
Week 4
|
12.8 mmHg
Standard Deviation 6.0
|
—
|
|
IOP Change
Month 3
|
14 mmHg
Standard Deviation 5.2
|
—
|
|
IOP Change
Month 6
|
15 mmHg
Standard Deviation 4.7
|
—
|
|
IOP Change
Month 9
|
15.3 mmHg
Standard Deviation 6.6
|
—
|
|
IOP Change
Month 12
|
15 mmHg
Standard Deviation 4
|
—
|
|
IOP Change
Month 24
|
14 mmHg
Standard Deviation 3
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 and 24 MonthsPopulation: Patients Taking Glaucoma Supplemental Treatment (Study Eye) ITT
Throughout the study, the number of glaucoma supplemental medications (derived as the number of medication classes) required after the IMS procedure.
Outcome measures
| Measure |
Success With Respect for IOP
n=78 Participants
The rates of success reflected sustained control of IOP
|
Need for Glaucoma Supplemental Treatment at M24
n=71 Participants
Patients Taking Glaucoma Supplemental Treatment (Study Eye)
|
|---|---|---|
|
Number of Participants Requiring Supplemental Medical Therapy at M12 and M24
|
25 Participants
|
25 Participants
|
Adverse Events
Subjects Suffering From Primary Open Angle Glaucoma
Serious events: 11 serious events
Other events: 67 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Subjects Suffering From Primary Open Angle Glaucoma
n=107 participants at risk
Subjects suffering from primary open angle glaucoma who are inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 35 mm Hg and/or.where glaucoma progression warrants surgery
|
|---|---|
|
Eye disorders
Allergic Keratitis
|
0.93%
1/107 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Eye disorders
Anterior Chamber Inflammation
|
0.93%
1/107 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Eye disorders
Cataract
|
0.93%
1/107 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Eye disorders
Ulcerative Keratitis
|
0.93%
1/107 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Investigations
Intraocular Pressure Increased
|
3.7%
4/107 • Number of events 4 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Surgical and medical procedures
Sclerectomy
|
0.93%
1/107 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Surgical and medical procedures
Trabeculectomy
|
0.93%
1/107 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
General disorders
Implant Site Dehiscence
|
0.93%
1/107 • Number of events 2 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
Other adverse events
| Measure |
Subjects Suffering From Primary Open Angle Glaucoma
n=107 participants at risk
Subjects suffering from primary open angle glaucoma who are inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 35 mm Hg and/or.where glaucoma progression warrants surgery
|
|---|---|
|
Eye disorders
Hypotony Of Eye
|
9.3%
10/107 • Number of events 10 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Eye disorders
Conjunctival Bleb
|
7.5%
8/107 • Number of events 10 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Eye disorders
Keratitis
|
7.5%
8/107 • Number of events 8 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Eye disorders
Lacrimation Increased
|
4.7%
5/107 • Number of events 6 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Eye disorders
Cataract
|
3.7%
4/107 • Number of events 5 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Eye disorders
Eye Pain
|
3.7%
4/107 • Number of events 5 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Eye disorders
Punctate Keratitis
|
3.7%
4/107 • Number of events 4 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Eye disorders
Visual Acuity Reduced
|
4.7%
5/107 • Number of events 5 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Eye disorders
Hyphaema
|
3.7%
4/107 • Number of events 4 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Eye disorders
Vision Blurred
|
1.9%
2/107 • Number of events 2 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Eye disorders
Eyelid Ptosis
|
2.8%
3/107 • Number of events 3 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Eye disorders
Flat Anterior Chamber Of Eye
|
2.8%
3/107 • Number of events 3 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Eye disorders
Ulcerative Keratitis
|
1.9%
2/107 • Number of events 2 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Eye disorders
Diplopia
|
1.9%
2/107 • Number of events 2 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Eye disorders
Dry Eye
|
1.9%
2/107 • Number of events 2 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Eye disorders
Eye Inflammation
|
0.93%
1/107 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Eye disorders
Eye Pruritus
|
0.93%
1/107 • Number of events 2 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Eye disorders
Allergic Keratitis
|
0.93%
1/107 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Eye disorders
Anterior Chamber Inflammation
|
0.93%
1/107 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Eye disorders
Choroidal Effusion
|
0.93%
1/107 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Eye disorders
Conjunctival Haemorrhage
|
0.93%
1/107 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Eye disorders
Conjunctival Hyperaemia
|
0.93%
1/107 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Eye disorders
Conjunctival Ulcer
|
0.93%
1/107 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Eye disorders
Corneal Oedema
|
0.93%
1/107 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Eye disorders
Iris Adhesions
|
0.93%
1/107 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Eye disorders
Posterior Capsule Opacification
|
0.93%
1/107 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Investigations
Intraocular Pressure Increased
|
24.3%
26/107 • Number of events 35 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
General disorders
Implant Site Dehiscence
|
5.6%
6/107 • Number of events 8 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
General disorders
Pain
|
1.9%
2/107 • Number of events 2 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
General disorders
Complication Of Device Insertion
|
0.93%
1/107 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
General disorders
Encapsulation Reaction
|
0.93%
1/107 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Injury, poisoning and procedural complications
Conjunctival Filtering Bleb Leak
|
1.9%
2/107 • Number of events 2 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Injury, poisoning and procedural complications
Anaesthetic Complication
|
0.93%
1/107 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Injury, poisoning and procedural complications
Suture Related Complication
|
1.9%
2/107 • Number of events 2 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Injury, poisoning and procedural complications
Post Procedural Complication
|
0.93%
1/107 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Injury, poisoning and procedural complications
Tenon's Cyst
|
0.93%
1/107 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Surgical and medical procedures
Cataract Operation
|
0.93%
1/107 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Surgical and medical procedures
Sclerectomy
|
1.9%
2/107 • Number of events 2 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Surgical and medical procedures
Trabeculectomy
|
0.93%
1/107 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Infections and infestations
Conjunctivitis
|
1.9%
2/107 • Number of events 2 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Infections and infestations
Hordeolum
|
0.93%
1/107 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Product Issues
Device Dislocation
|
1.9%
2/107 • Number of events 2 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Product Issues
Device Occlusion
|
0.93%
1/107 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
|
Product Issues
Needle Issue
|
0.93%
1/107 • Number of events 1 • Adverse events (AEs) were reported for the duration of the study (approximatively 36 months). This analysis population includes all patients who have signed the informed consent / enrolled in the study.
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
|
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