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Trabecular Micro-Bypass System

iStent Infinite vs. Competitor Device for Glaucoma

N/A

Waitlist Available

Research Sponsored by Glaukos Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of Primary Open-Angle Glaucoma (POAG) or Secondary Pseudoexfoliative Glaucoma (PEXG) or Secondary Pigmentary Glaucoma (PG)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 24

Awards & highlights

Study Summary

This trialfound the iStent Infinite product to be effective in treating glaucoma, outperforming its competitor.

Who is the study for?

This trial is for people with specific types of glaucoma: Primary Open-Angle Glaucoma, Secondary Pseudoexfoliative Glacoma, or Secondary Pigmentary Glaucoma. It's not suitable for those with other forms like traumatic, uveitic, neovascular glaucoma, angle closure glaucoma, and any linked to vascular disorders.Check my eligibility

What is being tested?

The study compares the iStent Infinite device against a competitor's product in treating open-angle glaucoma. Participants will receive one of these devices to see which is more effective.See study design

What are the potential side effects?

Potential side effects may include discomfort at the implant site, increased eye pressure, inflammation or bleeding inside the eye. These are common risks associated with similar eye procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with a specific type of glaucoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Mean Diurnal Intraocular Pressure

Trial Design

2Treatment groups

Active Control

Group I: iStent InfiniteActive Control1 Intervention

Subjects implanted with iStent Infinite system

Group II: Competitor DeviceActive Control1 Intervention

Subject implanted with competitor device

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Glaukos CorporationLead Sponsor

65 Previous Clinical Trials

8,896 Total Patients Enrolled

Media Library

iStent Infinite (Trabecular Micro-Bypass System) Clinical Trial Eligibility Overview. Trial Name: NCT05127551 — N/A

Open-Angle Glaucoma Research Study Groups: iStent Infinite, Competitor Device

Open-Angle Glaucoma Clinical Trial 2023: iStent Infinite Highlights & Side Effects. Trial Name: NCT05127551 — N/A

iStent Infinite (Trabecular Micro-Bypass System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05127551 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment into this experiment still taking place?

"Affirmative. According to information found on clinicaltrials.gov, this trial is actively searching for participants and was first posted on November 27th 2021. The latest update occured in December 7th 2022 and 85 patients are needed from a single medical centre."

Answered by AI

Does this clinical investigation accept geriatric participants?

"The selection criteria for this medical experiment requires that participants be between the ages of 35 and 85. Those younger than 18 have 23 studies they can enroll in, while those older than 65 are welcomed to join 200 others."

Answered by AI

What are the criteria for individuals to qualify as participants in this trial?

"To be approved for participation in this trial, candidates must have open-angle glaucoma and be between 35 to 85 years of age. Additionally, the study is looking to enroll approximately eighty five individuals."

Answered by AI

What is the current number of participants in this clinical research endeavor?

"Affirmative. Clinicaltrials.gov documents indicate that this medical study, initially publicized on November 27th 2021 is actively enlisting participants. Approximately 85 individuals must be enrolled from a single site to continue the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Clinical Study of Glaukos® Trabecular Micro-Bypass System Model iS3 Infinite Vs. Competitor

2021. "Clinical Study of Glaukos® Trabecular Micro-Bypass System Model iS3 Infinite Vs. Competitor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05127551.

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