Clinical trial NCT05583591: Combined Phacoemulsification With iStent Inject W Versus Hydrus for Mild to Moderate Open Angle Glaucoma
Official title: Prospective, Randomized Controlled Study Comparing Combined Phacoemulsification With iStent Inject W Versus Hydrus for Mild to Moderate Open Angle Glaucoma (COMPETE)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Open Angle Glaucoma
Keywords: Primary Open Angle Glaucoma
Hydrus
iStent
minimally invasive glaucoma surgery
MIGS
randomized
Lead sponsor: Diablo Eye Associates
Sponsor class: INDUSTRY
Collaborators: name: Alcon Research
First posted: 2022-10-17
Enrollment: 58
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Intraoperative and postoperative adverse events rates
timeFrame: 24 Months
measure: Rates of secondary intervention to reduce intraocular pressure
timeFrame: 24 Months
measure: Rates of needing incisional glaucoma surgery as secondary intervention to control interocular pressure
timeFrame: 24 Months
Other outcomes:
Locations:
city: Walnut Creek
country: United States
facility: Diablo Eye Associates
state: California
Study officials:
References: