← Back to Search

Trabecular Meshwork Targeting Microstent

Phacoemulsification with Hydrus vs. iStent for Glaucoma

N/A
Recruiting
Research Sponsored by Diablo Eye Associates
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Visually significant cataract
Age >60 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial compares two medical devices that can be used to treat glaucoma during cataract surgery.

Who is the study for?
This trial is for people over 60 with mild to moderate open angle glaucoma, controlled on medication, and having visually significant cataract. They should have an IOP between 21-36 mmHg after stopping glaucoma meds and a corneal thickness of 480-620μm. Excluded are those who can't do certain eye tests, had previous eye surgeries (other than cataract), or have other types of glaucoma or serious eye conditions.Check my eligibility
What is being tested?
The study compares two FDA-approved microstents—Hydrus and iStent Inject W—used in conjunction with cataract surgery to treat open angle glaucoma. Patients will be randomly assigned to receive either the Hydrus microstent or the iStent Inject W during their cataract surgery.See study design
What are the potential side effects?
Potential side effects may include discomfort at the implant site, increased intraocular pressure, inflammation inside the eye, bleeding inside the anterior chamber of the eye, and possible vision disturbances post-surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a cataract that affects my vision significantly.
Select...
I am older than 60 years.
Select...
I am having cataract surgery with a lens implant and a microstent.
Select...
I haven't had laser eye treatment in the last 6 months and no glaucoma implants.
Select...
My eye exam shows signs of glaucoma with a specific optic nerve ratio.
Select...
My glaucoma is under control with medication.
Select...
I have never had eye surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmaceutical Preparations
Secondary outcome measures
Intraoperative and postoperative adverse events rates
Interventional procedure
Rates of secondary intervention to reduce intraocular pressure

Trial Design

2Treatment groups
Active Control
Group I: Combined cataract surgery with Hydrus microstentActive Control2 Interventions
Group II: Combined cataract surgery with iStent Inject WActive Control2 Interventions

Find a Location

Who is running the clinical trial?

Diablo Eye AssociatesLead Sponsor
Alcon ResearchIndustry Sponsor
703 Previous Clinical Trials
124,081 Total Patients Enrolled

Media Library

Hydrus microstent (Trabecular Meshwork Targeting Microstent) Clinical Trial Eligibility Overview. Trial Name: NCT05583591 — N/A
Open-Angle Glaucoma Research Study Groups: Combined cataract surgery with Hydrus microstent, Combined cataract surgery with iStent Inject W
Open-Angle Glaucoma Clinical Trial 2023: Hydrus microstent Highlights & Side Effects. Trial Name: NCT05583591 — N/A
Hydrus microstent (Trabecular Meshwork Targeting Microstent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05583591 — N/A

Frequently Asked Questions

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

Is participation in this trial still open to the public?

"According to clinicaltrials.gov, this research endeavour is presently recruiting patients for the trial which was initially made available on October 1st 2022 and was recently revised on October 14th of that same year."

Answered by AI

What is the participant count for this clinical experiment?

"Affirmative. Clinicaltrials.gov data implies that this trial is currently looking for participants, with its first posting on October 1st 2022 and last update occurring two weeks later. The research team needs 390 volunteers to be recruited from one site."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Diablo Eye Associates
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
~195 spots leftby Oct 2025