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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
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 belowSelect...
I have a cataract that affects my vision significantly.
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I am older than 60 years.
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I am having cataract surgery with a lens implant and a microstent.
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I haven't had laser eye treatment in the last 6 months and no glaucoma implants.
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My eye exam shows signs of glaucoma with a specific optic nerve ratio.
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My glaucoma is under control with medication.
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I have never had eye surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a cataract that affects my vision significantly.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.My glaucoma is under control with medication.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.My glaucoma is under control with medication.I haven't had specific eye treatments or implants for glaucoma in the last 6 months.I do not have serious eye diseases affecting my vision or eye scans.I have never had eye surgery.I am 60 years old or older.I have a cataract that affects my vision significantly.I am having cataract surgery with a lens implant and a microstent.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.
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
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