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

Diablo Eye Associates

Status

Terminated

Conditions

Open Angle Glaucoma

Treatments

Device: Combined cataract surgery with iStent Inject W

Device: Combined cataract surgery with Hydrus microstent

Study type

Interventional

Funder types

Industry

Identifiers

NCT05583591

COMPETE Trial

Details and patient eligibility

About

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.

Enrollment

58 patients

Sex

All

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

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.