Primary Angle Closure GlaucomaNCT04622605
Hydrus Microstent and Lens Extraction for the Treatment of Primary Angle-Closure Glaucoma
A study testing Trabecular bypass and Schlemm's canal stent in people with Primary Angle Closure Glaucoma and Primary Angle Closure, run by Asian Eye Institute at 1 site in Philippines.
Trial summary
This study is a prospective evaluation of the Hydrus Microstent for the treatment of Primary Angle Closure (PAC) and Primary Angle Closure Glaucoma (PACG) with adjunctive cataract. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Primary Angle Closure Glaucoma, Primary Angle Closure
- What is being tested?
- Trabecular bypass and Schlemm's canal stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 sitePhilippines
- Study dates
- 13 Jun 2017to 23 Dec 2021
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pre-Operative Inclusion Criteria
- Male and Female patients at least 40 years of age.
- An operable age-related cataract with visual impairment or glare, eligible for phacoemulsification.
- Subjects with diagnosed primary angle-closure (PAC; defined as appositional or synechial irido-trabecular contact of 90 degrees or more on gonionscopy) OR primary angle-closure glaucoma (PACG; defined as PAC with documented glaucomatous optic neuropathy and/or reproducible glaucomatous visual field defect), and on > or = 1 glaucoma medication with IOP > or = 21mmHg at both preoperative visits.
- PAC or PACG subjects that are newly diagnosed, or unmedicated (newly diagnosed or non-compliant patient not using medication for > 30 days), with IOP > or = 24mmHg at both preoperative visits.
- The subject is able to understand the requirements of the study and is willing to provide written informed consent, follow study instructions, and comply with all study procedures.
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- Intraoperative Inclusion Critera
- An intact and centered capsulorhexis.
- An intact posterior capsular bag.
- A well-centered IOL implant placed in the capsular bag.
- A clear view and visualization of the angle with direct gonioscopy.
- No evidence of zonular dehiscence/rupture (uncomplicated cataract extraction)
Who cannot join
- Pseudophakia in the intended study eye
- All forms of glaucoma other than primary angle-closure (i.e. all open-angle glaucoma including primary open-angle, pseudoexfoliative, or pigmentary glaucoma; neovascular, uveitic, traumatic, steroid induced, lens induced, or glaucoma associated with increased episcleral venous pressure; congenital or developmental glaucoma).
- Secondary angle-closure glaucoma
- Advanced glaucoma, defined as visual field mean deviation worse than -15 dB, or cup-to-disc ration > or = 0.9.
- Visual field depression within the central 5 degrees of fixation, on pattern deviation probability plot.
- Eyes with an anticipated need for incisional glaucoma surgery (e.g. trabeculectomy or tube shunt) within the 12-month follow-up period.
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- Central corneal thickness >620 or <490 microns.
- Axial length < or = 19 mm (nanophthalmos).
- Previous incisional glaucoma surgery in the study eye, including trabeculectomy, tube shunt, and non-penetrating procedures such as deep sclerectomy, viscocanalostomy or canaloplasty.
- Plateau iris syndrome.
- History of complicated intraocular surgery.
- Previous MIGS surgery in the study eye.
- Proliferative diabetic retinopathy.
- Previous surgery for retinal detachment.
- Clinically significant corneal dystrophy (e.g. Fuch's Dystrophy).
- Best-corrected visual acuity in the fellow eye worse than 20/200.
- Previous corneal surgery.
- Previous refractive surgery.
- Degenerative visual disorders such as exudative age-related macular degeneration.
- Clinically significant ocular inflammation or infection within thirty days prior to screening.
- Uncontrolled systemic disease that in the opinion of the investigator would put the subject's health at risk and/or prevent the subject from completing all study visits.
- Pregnant or nursing females.
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Asian Eye Institute
Makati City, National Capital Region, 1200
About this study
This study is a prospective evaluation of the Hydrus Microstent for the treatment of Primary Angle Closure (PAC) and Primary Angle Closure Glaucoma (PACG) with adjunctive cataract. A total of 20 subjects will be successfully treated with one Hydrus device after completion of cataract extraction with phacoemulsification followed by IOL replacement (HMS cohort), and 10 eyes will be treated with phacoemulsification cataract extraction and IOL replacement only (PCS group). Since cataract surgery is standard of care for this condition, eligible fellow eyes from the HMS cohort may be enrolled into the PCS group. To avoid selection bias in this non-randomized study, the first 20 consecutive qualifying subjects will be treated with Hydrus and the next 10 consecutive qualifying eyes will be treated with cataract surgery only.
Read the detailed description
The objective of this study is to assess the effectiveness of the Hydrus Microstent for lowering intraocular pressure in patients with PAC or PACG. The addition of the Hydrus is expected to lower IOP and medication dependency, and thus reduce the risk of progression of glaucoma. The PCS group will provide a control group to assess the magnitude of the Hydrus treatment effect on IOP, medications, and safety.
Upon successfully meeting the study inclusion/exclusion criteria at both the screening and baseline visits, the subject will be scheduled for surgery. Follow up will be continued for 1 year post surgery, and will include assessments of the subject's IOP, ocular health, and visual acuity status. Visits will be conducted at 1, 7, 30, 90, 180, and 365 days.
A 20% drop in IOP in response to therapy is considered clinically meaningful. The study treatment will be considered successful if a patient can obtain this response in IOP using the same or a fewer number of medications as pre-operative baseline.
- Being tested
- Trabecular bypass and Schlemm's canal stent
- Medical subject headings
- Glaucoma, Angle-Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trabecular bypass and Schlemm's canal stentDevice
Also called Hydrus Microstent
ab interno Microstent placement after cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Cataract extraction and intraocular lens placement with combined placement of glaucoma microstent Receives: Device: Trabecular bypass and Schlemm's canal stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in IOP
Proportion of subjects with > or = 20% reduction of IOP while maintaining the same or fewer number of glaucoma medications compared with baseline, measured by Goldmann applanation tonometry
Measured: 12 months
Secondary outcomes (1)
Change in IOP
Change in IOP compared to baseline IOP regardless of the number of glaucoma medications
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start13 Jun 2017
- Primary completion1 Sep 2021
- Study completion23 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Angle Closure 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asian Eye Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ivantis, Inc.
- Responsible party
- Principal investigator, Robert Edward T. Ang, Asian Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622605
- Sponsor's protocol ID
- 2017-004
- Status last verified
- Feb 2022
- First submitted
- 5 Nov 2020
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydrus Microstent and Lens Extraction for the Treatment of Primary Angle-Closure Glaucoma
- ClinicalTrials.gov ID
- NCT04622605
- Acronym / sponsor ID
- 2017-004
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Asian Eye InstituteIndustry (pharma, biotech, devices)
- Collaborators
- Ivantis, Inc.
- Study start
- 13 Jun 2017 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 23 Dec 2021 (actual)
- First posted
- 10 Nov 2020 (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.
This study is a prospective evaluation of the Hydrus Microstent for the treatment of Primary Angle Closure (PAC) and Primary Angle Closure Glaucoma (PACG) with adjunctive cataract. A total of 20 subjects will be successfully treated with one Hydrus device after completion of cataract extraction with phacoemulsification followed by IOL replacement (HMS cohort), and 10 eyes will be treated with phacoemulsification cataract extraction and IOL replacement only (PCS group). Since cataract surgery is standard of care for this condition, eligible fellow eyes from the HMS cohort may be enrolled into the PCS group. To avoid selection bias in this non-randomized study, the first 20 consecutive qualifying subjects will be treated with Hydrus and the next 10 consecutive qualifying eyes will be treated with cataract surgery only.
Detailed description
The objective of this study is to assess the effectiveness of the Hydrus Microstent for lowering intraocular pressure in patients with PAC or PACG. The addition of the Hydrus is expected to lower IOP and medication dependency, and thus reduce the risk of progression of glaucoma. The PCS group will provide a control group to assess the magnitude of the Hydrus treatment effect on IOP, medications, and safety.
Upon successfully meeting the study inclusion/exclusion criteria at both the screening and baseline visits, the subject will be scheduled for surgery. Follow up will be continued for 1 year post surgery, and will include assessments of the subject's IOP, ocular health, and visual acuity status. Visits will be conducted at 1, 7, 30, 90, 180, and 365 days.
A 20% drop in IOP in response to therapy is considered clinically meaningful. The study treatment will be considered successful if a patient can obtain this response in IOP using the same or a fewer number of medications as pre-operative baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Trabecular bypass and Schlemm's canal stentCataract extraction and intraocular lens placement with combined placement of glaucoma microstent |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Pre-Operative Inclusion Criteria
- Male and Female patients at least 40 years of age.
- An operable age-related cataract with visual impairment or glare, eligible for phacoemulsification.
- Subjects with diagnosed primary angle-closure (PAC; defined as appositional or synechial irido-trabecular contact of 90 degrees or more on gonionscopy) OR primary angle-closure glaucoma (PACG; defined as PAC with documented glaucomatous optic neuropathy and/or reproducible glaucomatous visual field defect), and on > or = 1 glaucoma medication with IOP > or = 21mmHg at both preoperative visits.
- PAC or PACG subjects that are newly diagnosed, or unmedicated (newly diagnosed or non-compliant patient not using medication for > 30 days), with IOP > or = 24mmHg at both preoperative visits.
Key exclusion criteria (22 listed)
- Pseudophakia in the intended study eye
- All forms of glaucoma other than primary angle-closure (i.e. all open-angle glaucoma including primary open-angle, pseudoexfoliative, or pigmentary glaucoma; neovascular, uveitic, traumatic, steroid induced, lens induced, or glaucoma associated with increased episcleral venous pressure; congenital or developmental glaucoma).
- Secondary angle-closure glaucoma
- Advanced glaucoma, defined as visual field mean deviation worse than -15 dB, or cup-to-disc ration > or = 0.9.
- Visual field depression within the central 5 degrees of fixation, on pattern deviation probability plot.
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 |
|---|---|---|
| Trabecular bypass and Schlemm's canal stentAlso: Hydrus Microstentab interno Microstent placement after cataract surgery | Device | Treatment Group |
Primary outcome
Reduction in IOP
Time frame: 12 months
Proportion of subjects with > or = 20% reduction of IOP while maintaining the same or fewer number of glaucoma medications compared with baseline, measured by Goldmann applanation tonometry
1 secondary outcome
Change in IOP
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
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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 Trabecular bypass and Schlemm's canal stent in people with Primary Angle Closure Glaucoma and Primary Angle Closure, run by Asian Eye Institute at 1 site in Philippines.
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 12 inclusion and 22 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: finished, as of the sponsor's last update on 16 Feb 2022. 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 Philippines. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction in IOP (time frame: 12 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 16 Feb 2022.