Open Angle GlaucomaNCT05583591
Combined Phacoemulsification With iStent Inject W Versus Hydrus for Mild to Moderate Open Angle Glaucoma
A study testing Combined cataract surgery with Hydrus microstent and Combined cataract surgery with iStent Inject W in people with Open Angle Glaucoma, run by Diablo Eye Associates at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- Combined cataract surgery with Hydrus microstent and Combined cataract surgery with iStent Inject W
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 22 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >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
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- 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 join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Diablo Eye Associates
Walnut Creek, California, 94598
About this study
Official title: Prospective, Randomized Controlled Study Comparing Combined Phacoemulsification With iStent Inject W Versus Hydrus for Mild to Moderate Open Angle Glaucoma (COMPETE)
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.
- Conditions
- Open Angle Glaucoma
- Being tested
- Combined cataract surgery with Hydrus microstent, Combined cataract surgery with iStent Inject W
- Keywords
- Primary Open Angle Glaucoma, Hydrus, iStent, minimally invasive glaucoma surgery, MIGS, randomized
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined cataract surgery with Hydrus microstentDevice
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 WDevice
Device designed to help lower intraocular pressure by improving aqueous outflow through the trabecular meshwork. Used in combination with cataract surgery.
| Study group | Role | What they receive |
|---|---|---|
| Combined cataract surgery with Hydrus microstent | Active comparator | Not described Receives: Device: Combined cataract surgery with Hydrus microstent; Device: Combined cataract surgery with iStent Inject W |
| Combined cataract surgery with iStent Inject W | Active comparator | Not described Receives: Device: Combined cataract surgery with Hydrus microstent; Device: Combined cataract surgery with iStent Inject W |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 Months
Secondary outcomes (3)
Intraoperative and postoperative adverse events rates
Measured: 24 Months
Rates of secondary intervention to reduce intraocular pressure
Measured: 24 Months
Rates of needing incisional glaucoma surgery as secondary intervention to control interocular pressure
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start1 Oct 2022
- Primary completion22 Apr 2024
- Study completion22 Apr 2024
Why it stopped: Slow enrollment, sites unable to obtain iStent Inject W from manufacturer
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diablo Eye Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583591
- Sponsor's protocol ID
- COMPETE Trial
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2022
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Controlled Study Comparing Combined Phacoemulsification With iStent Inject W Versus Hydrus for Mild to Moderate Open Angle Glaucoma (COMPETE)
- ClinicalTrials.gov ID
- NCT05583591
- Acronym / sponsor ID
- COMPETE Trial
- Conditions
- Open Angle Glaucoma
- Keywords
- Primary Open Angle Glaucoma, Hydrus, iStent, minimally invasive glaucoma surgery, MIGS, randomized
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment, sites unable to obtain iStent Inject W from manufacturer
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Diablo Eye AssociatesIndustry (pharma, biotech, devices)
- Collaborators
- Alcon Research
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 22 Apr 2024 (actual)
- Study completion
- 22 Apr 2024 (actual)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined cataract surgery with Hydrus microstent | Active comparator | Device: Combined cataract surgery with Hydrus microstent, Device: Combined cataract surgery with iStent Inject W |
| Combined cataract surgery with iStent Inject W | Active comparator | Device: Combined cataract surgery with Hydrus microstent, Device: Combined cataract surgery with iStent Inject W |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- >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)
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined cataract surgery with Hydrus microstentDevice 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 Hydrus microstent, Combined cataract surgery with iStent Inject W |
| Combined cataract surgery with iStent Inject WDevice 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 Hydrus microstent, Combined cataract surgery with iStent Inject W |
Primary outcome
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
3 secondary outcomes
Intraoperative and postoperative adverse events rates
Time frame: 24 Months
Rates of secondary intervention to reduce intraocular pressure
Time frame: 24 Months
Rates of needing incisional glaucoma surgery as secondary intervention to control interocular pressure
Time frame: 24 Months
Results and safety
The study was stopped early (reason given: Slow enrollment, sites unable to obtain iStent Inject W from manufacturer). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined cataract surgery with Hydrus microstent and Combined cataract surgery with iStent Inject W in people with Open Angle Glaucoma, run by Diablo Eye Associates at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow enrollment, sites unable to obtain iStent Inject W from manufacturer). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.