iStent Inject Trabecular Micro-Bypass System Continuation Post-Approval Study

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04624685

Enrollment

475

Registered

2020-11-12

Start date

2020-01-15

Completion date

2021-12-31

Last updated

2021-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Open-Angle

Brief summary

Long term follow up of subjects in the IDE study for iStent Inject to monitor safety

Detailed description

To evaluate the long -term rate of clinically relevant complications associated with iStent inject® placement and stability in subjects who have completed participation of the IDE clinical trial (GC-008).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Randomized subject followed for 24 months in the GC-008 study * Able to understand study requirements * Willing to attend scheduled follow-up exams for 5 years post-operatively * Able and willing to provide written informed consent on the IRB approved Informed Consent Form

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame	Description
iStent inject Placement and Stability	60 Months	Rate of clinically relevant complications associated with iStent inject placement and stability.

Secondary

Measure	Time frame	Description
Sight-Threatening Adverse Events	60 Months	Rate of occurrence of sight-threatening adverse events

Other

Measure	Time frame	Description
Secondary Surgical Interventions	60 Months	Rate of Secondary Surgical Interventions
Adverse Events	60 Months	Rate of other adverse Events

Countries

United States

Outcome results