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

NCT05583591 | Terminated DMC FDA Device

• 1 other identifier: COMPETE Trial
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Open Angle Glaucoma

Keywords

Primary Open Angle Glaucoma; Hydrus; iStent; minimally invasive glaucoma surgery; MIGS; randomized

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Combined cataract surgery with Hydrus microstent

ACTIVE COMPARATOR

Device: Combined cataract surgery with Hydrus microstent; Device: Combined cataract surgery with iStent Inject W

Combined cataract surgery with iStent Inject W

ACTIVE COMPARATOR

Device: Combined cataract surgery with Hydrus microstent; Device: Combined cataract surgery with iStent Inject W

Interventions

Combined cataract surgery with Hydrus microstent DEVICE

Device designed to help lower intraocular pressure by improving aqueous outflow through the trabecular meshwork. Used in combination with cataract surgery.

Combined cataract surgery with Hydrus microstent; Combined cataract surgery with iStent Inject W

Combined cataract surgery with iStent Inject W DEVICE

Device designed to help lower intraocular pressure by improving aqueous outflow through the trabecular meshwork. Used in combination with cataract surgery.

Combined cataract surgery with Hydrus microstent; Combined cataract surgery with iStent Inject W

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Diablo Eye Associates: lead
• Alcon Research: collaborator

Study Sites (1)

Diablo Eye Associates

Walnut Creek, California, 94598, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 17, 2022
• Study Start: October 1, 2022
• Primary Completion: April 22, 2024
• Study Completion: April 22, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10

Locations

US (1)