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TerminatedNo phase
Combined Phacoemulsification With iStent Inject W Versus Hydrus for Mild to Moderate Open Angle Glaucoma
Key facts
- Who runs it
- Diablo Eye Associates
- Where
- Walnut Creek, United StatesSee the site
- Trial code
- Status
- Terminated
- People taking part
- 58 people enrolled
- Started
- 1 Oct 2022
- Ended
- 22 Apr 2024
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Combined cataract surgery with Hydrus microstent
- Combined cataract surgery with iStent Inject W
- Record updated
- 1 November 2024
- Why it stopped
- Slow enrollment, sites unable to obtain iStent Inject W from manufacturer
Who can take part
- Age
- 60 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 21 criteriaShow less
Who can take part
- >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
Who cannot take part
- Prior intraocular surgery
- Uncontrolled intraocular pressure on maximum tolerated medical therapy
- 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
- Corneal disease or dystrophy
- Clinically significant ocular pathology or degenerative diseases that affect vision, visual field, or optical coherence tomography of optic nerve
- Visual field MD ≥ -12 dB
- Unable to perform wash-out IOP
- Anatomic exclusion of narrow anterior chamber angle (Shaffer grade I-II), other angle abnormalities including angle closure glaucoma
- Pathological myopia with degeneration that affects diagnostic imaging
- Inability to perform reliable Visual Field and optical coherence tomography
Where in United States
- Diablo Eye AssociatesWalnut Creek, United States
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Combined cataract surgery with Hydrus microstentExisting treatment, for comparison
Treatment: Combined cataract surgery with Hydrus microstent and Combined cataract surgery with iStent Inject W
- Combined cataract surgery with iStent Inject WExisting treatment, for comparison
Treatment: Combined cataract surgery with Hydrus microstent and Combined cataract surgery with iStent Inject W
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Prospective, Randomized Controlled Study Comparing Combined Phacoemulsification With iStent Inject W Versus Hydrus for Mild to Moderate Open Angle Glaucoma (COMPETE)
- Record updated
- 1 November 2024