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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
730 Previous Clinical Trials
128,791 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My eye pressure is high despite using all possible treatments.My severe nearsightedness affects medical imaging tests.I have a cataract that affects my vision significantly.My eye condition does not include a narrow angle or angle closure glaucoma.I have a type of glaucoma caused by another condition.My glaucoma is caused by high pressure in my eye veins.I am older than 60 years.I am having cataract surgery with a lens implant and a microstent.My eye exam shows signs of glaucoma with a cup-to-disc ratio of 0.8 or less.I have a corneal disease.I have had eye surgery before.I have never had eye surgery.My eye exam shows signs of glaucoma with a specific optic nerve ratio.My glaucoma is under control with medication.I haven't had laser eye treatment in the last 6 months and no glaucoma implants.I do not have serious eye diseases affecting my vision or eye scans.I am 60 years old or older.I am having cataract surgery with a lens implant and a microstent.
Research Study Groups:
This trial has the following groups:- Group 1: Combined cataract surgery with Hydrus microstent
- Group 2: Combined cataract surgery with iStent Inject W
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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