Open Angle Glaucoma
Conditions
Keywords
Primary Open Angle Glaucoma, Hydrus, iStent, minimally invasive glaucoma surgery, MIGS, randomized
Brief 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.
Interventions
DEVICECombined cataract surgery with Hydrus microstent
Device designed to help lower intraocular pressure by improving aqueous outflow through the trabecular meshwork. Used in combination with cataract surgery.
DEVICECombined cataract surgery with iStent Inject W
Device designed to help lower intraocular pressure by improving aqueous outflow through the trabecular meshwork. Used in combination with cataract surgery.
Sponsors
Alcon Research
Diablo Eye Associates
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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 tomography.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 24 Months |
Secondary
| Measure | Time frame |
|---|---|
| Intraoperative and postoperative adverse events rates | 24 Months |
| Rates of secondary intervention to reduce intraocular pressure | 24 Months |
| Rates of needing incisional glaucoma surgery as secondary intervention to control interocular pressure | 24 Months |
Countries
United States
Outcome results
None listed