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

• Sponsor: Diablo Eye Associates (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05583591
• Collaborator: Alcon Research (Industry)
• Enrollment: 390
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 10.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Open Angle Glaucoma	Device: Combined cataract surgery with Hydrus microstent; Device: Combined cataract surgery with iStent Inject W	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 390 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Prospective, Randomized Controlled Study Comparing Combined Phacoemulsification With iStent Inject W Versus Hydrus for Mild to Moderate Open Angle Glaucoma (COMPETE)
• Actual Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: Oct 1, 2025
• Anticipated Study Completion Date: Oct 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.
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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. Intraoperative and postoperative adverse events rates [24 Months]

2. Rates of secondary intervention to reduce intraocular pressure [24 Months]

3. Rates of needing incisional glaucoma surgery as secondary intervention to control interocular pressure [24 Months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Diablo Eye Associates	Walnut Creek	California	United States	94598

Sponsors and Collaborators

• Diablo Eye Associates
• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Diablo Eye Associates
• ClinicalTrials.gov Identifier: NCT05583591
• Other Study ID Numbers: COMPETE Trial
• First Posted: Oct 17, 2022
• Last Update Posted: Oct 17, 2022
• Last Verified: Oct 1, 2022

• 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
• Keywords provided by Diablo Eye Associates: Primary Open Angle Glaucoma; Hydrus; iStent; minimally invasive glaucoma surgery; MIGS; randomized
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle

Study Results

No Results Posted as of Oct 17, 2022