TerminatedNot Applicable

Combined Phacoemulsification With iStent Inject W Versus Hydrus for Mild to Moderate Open Angle Glaucoma

Stopped: Slow enrollment, sites unable to obtain iStent Inject W from manufacturer

United States58 participantsStarted 2022-10-01

Plain-language summary

The goal of the study is to prospectively evaluate and compare Hydrus microstent to the iStent Inject Wide in combination with cataract surgery in patients with mild to moderate open angle glaucoma. Hydrus and iStent are the two FDA approved trabecular meshwork targeting microstents to treat open angle glaucoma in conjunction with cataract surgery.

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * \>60 years or older * Visually significant cataract * Mild to moderate primary open angle glaucoma controlled on medications * undergoing cataract surgery with lens implantation and concurrent microstent placement * IOP ≥ 21 mmHg and ≤ 36 mmHg after washout of ocular hypotensive medication(s) * CCT 480 to 620μm * No prior ocular surgery including corneal refractive surgery * No SLT within 6 months of baseline visit, no history of intracameral glaucoma drug eluting implants * Visual field mean deviation ≤ -12 dB * Optic nerve abnormalities consistent with glaucoma, C/D ratio less than ≤0.8 Exclusion Criteria: * Prior intraocular surgery * Visual field MD ≥ -12 dB * secondary glaucoma including uveitis, traumatic, malignant, neovascular, and congenital glaucoma. * Glaucoma related to elevated episcleral venous pressure including Sturge-Weber syndrome, thyroid eye disease, orbital tumor, and etc. * Uncontrolled intraocular pressure on maximum tolerated medical therapy; * Unable to perform wash-out IOP * Anatomic exclusion of narrow anterior chamber angle (Shaffer grade I-II), other angle abnormalities including angle closure glaucoma * Corneal disease or dystrophy * Pathological myopia with degeneration that affects diagnostic imaging * Clinically significant ocular pathology or degenerative diseases that affect vision, visual field, or optical coherence tomography of optic nerve. * Inability to perform reliable Visual Field and optical coherence tomogra…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of subjects with complete success defined as intraocular pressure reduction > 25% from baseline And without secondary intervention to reduce IOP (medication, laser trabeculoplasty, or surgery) at 24 month.

Timeframe: 24 Months

Trial details

NCT IDNCT05583591

SponsorDiablo Eye Associates

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04-22

View on ClinicalTrials.gov More Open Angle Glaucoma trials