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

Not Applicable

Terminated

• Conditions: Open Angle Glaucoma
• Interventions: Device: Combined cataract surgery with Hydrus microstent; Device: Combined cataract surgery with iStent Inject W

• Registration Number: NCT05583591
• Lead Sponsor: Diablo Eye Associates

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-01
• Study First Submitted: 2022-10-14
• Study First Submitted QC: 2022-10-14
• Study First Posted: 2022-10-17
• Primary Completion: 2024-04-22
• Study Completion: 2024-04-22
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 58

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined cataract surgery with Hydrus microstent	Combined cataract surgery with Hydrus microstent	-
Combined cataract surgery with iStent Inject W	Combined cataract surgery with Hydrus microstent	-
Combined cataract surgery with Hydrus microstent	Combined cataract surgery with iStent Inject W	-
Combined cataract surgery with iStent Inject W	Combined cataract surgery with iStent Inject W	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Intraoperative and postoperative adverse events rates	24 Months
Rates of needing incisional glaucoma surgery as secondary intervention to control interocular pressure	24 Months
Rates of secondary intervention to reduce intraocular pressure	24 Months

Trial Locations

Locations (1)

Diablo Eye Associates; 🇺🇸 Walnut Creek, California, United States