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

Prospective, Randomized Controlled Study Comparing Combined Phacoemulsification With iStent Inject W Versus Hydrus for Mild to Moderate Open Angle Glaucoma (COMPETE)

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.

Study Overview

• Status: Recruiting
• Conditions: Open Angle Glaucoma
• Intervention / Treatment: Device: Combined cataract surgery with Hydrus microstent; Device: Combined cataract surgery with iStent Inject W

• Study Type: Interventional
• Enrollment (Estimated): 390
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric Viloria, OD; Phone Number: 7147452003; Email: eric_viloria@berkeley.edu
• Study Contact Backup: Name: Yen Hsia, MD; Email: yenchsia@gmail.com

Study Locations

• United States
  • California
    • Walnut Creek, California, United States, 94598
      • Recruiting
      • Diablo Eye Associates
      • Contact: Eric Viloria, OD; Phone Number: 7147452003; Email: eric_viloria@berkeley.edu
      • Contact: Yen Hsia, MD; Email: yenchsia@gmail.com
      • Principal Investigator: Yen Hsia, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Combined cataract surgery with iStent Inject W	Device: Combined 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.; Device: Combined 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.
Active Comparator: Combined cataract surgery with Hydrus microstent	Device: Combined 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.; Device: Combined 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.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Diablo Eye Associates
• Collaborators: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: October 14, 2022
• First Posted (Actual): October 17, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: randomized; Primary Open Angle Glaucoma; Hydrus; iStent; minimally invasive glaucoma surgery; MIGS
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: COMPETE Trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes