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

Open Angle Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05583591
• Other study ID #: COMPETE Trial
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: October 2025

Study information

• Verified date: February 2024
• Source: Diablo Eye Associates
• Contact: Eric Viloria, OD
• Phone: 7147452003
• Email: eric_viloria[@]berkeley.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 390
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Open Angle Glaucoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Diablo Eye Associates	Walnut Creek	California

Sponsors (2)

Lead Sponsor	Collaborator
Diablo Eye Associates	Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intraoperative and postoperative adverse events rates		24 Months
Secondary	Rates of secondary intervention to reduce intraocular pressure		24 Months
Secondary	Rates of needing incisional glaucoma surgery as secondary intervention to control interocular pressure		24 Months