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

Primary Purpose

Open Angle Glaucoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Combined cataract surgery with Hydrus microstent
Combined cataract surgery with iStent Inject W
Sponsored by
Diablo Eye Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open Angle Glaucoma focused on measuring Primary Open Angle Glaucoma, Hydrus, iStent, minimally invasive glaucoma surgery, MIGS, randomized

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Diablo Eye AssociatesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combined cataract surgery with Hydrus microstent

Combined cataract surgery with iStent Inject W

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 14, 2022
Last Updated
October 14, 2022
Sponsor
Diablo Eye Associates
Collaborators
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT05583591
Brief Title
Prospective, Randomized Controlled Study Comparing Combined Phacoemulsification With iStent Inject W Versus Hydrus for Mild to Moderate Open Angle Glaucoma
Official Title
Prospective, Randomized Controlled Study Comparing Combined Phacoemulsification With iStent Inject W Versus Hydrus for Mild to Moderate Open Angle Glaucoma (COMPETE)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Diablo Eye Associates
Collaborators
Alcon Research

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma
Keywords
Primary Open Angle Glaucoma, Hydrus, iStent, minimally invasive glaucoma surgery, MIGS, randomized

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
390 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined cataract surgery with Hydrus microstent
Arm Type
Experimental
Arm Title
Combined cataract surgery with iStent Inject W
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Combined cataract surgery with Hydrus microstent
Intervention Description
Device designed to help lower intraocular pressure by improving aqueous outflow through the trabecular meshwork. Used in combination with cataract surgery.
Intervention Type
Device
Intervention Name(s)
Combined cataract surgery with iStent Inject W
Intervention Description
Device designed to help lower intraocular pressure by improving aqueous outflow through the trabecular meshwork. Used in combination with cataract surgery.
Primary Outcome Measure Information:
Title
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.
Time Frame
24 Months
Secondary Outcome Measure Information:
Title
Intraoperative and postoperative adverse events rates
Time Frame
24 Months
Title
Rates of secondary intervention to reduce intraocular pressure
Time Frame
24 Months
Title
Rates of needing incisional glaucoma surgery as secondary intervention to control interocular pressure
Time Frame
24 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Viloria, OD
Phone
7147452003
Email
eric_viloria@berkeley.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Yen Hsia, MD
Email
yenchsia@gmail.com
Facility Information:
Facility Name
Diablo Eye Associates
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yen Hsia, MD
Email
yenchsia@gmail.com
First Name & Middle Initial & Last Name & Degree
Eric Viloria, OD
Phone
7147452003
Email
eric_viloria@berkeley.edu
First Name & Middle Initial & Last Name & Degree
Yen Hsia, MD

12. IPD Sharing Statement

Learn more about this trial

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

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