Combined Phacoemulsification With iStent Inject W Versus Hydrus for Mild to Moderate Open Angle Glaucoma
NCT ID: NCT05583591
Last Updated: 2024-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
58 participants
INTERVENTIONAL
2022-10-01
2024-04-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Combined cataract surgery with Hydrus microstent
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.
Combined cataract surgery with iStent Inject W
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
60 Years
ALL
Yes
Sponsors
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Alcon Research
INDUSTRY
Diablo Eye Associates
INDUSTRY
Responsible Party
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Locations
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Diablo Eye Associates
Walnut Creek, California, United States
Countries
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Other Identifiers
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COMPETE Trial
Identifier Type: -
Identifier Source: org_study_id
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