GlaucomaNCT04796883
A Study for Assessing the Safety of Hanita Glaucoma Shunt in Glaucoma Patients
A study testing Hanita Glaucoma shunt Ver.3.2 in people with Glaucoma, run by Hanita Lenses at 1 site in Spain.
Trial summary
The HANITA Glaucoma Filtration Device is intended to reduce intraocular pressure in glaucoma patients where medical and conventional surgical treatments have failed. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Hanita Glaucoma shunt Ver.3.2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jun 2015to 15 Nov 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is between 40 and 80 years of age
- Subject diagnosed with primary Open-angle glaucoma
- Subject is Diagnosed with glaucoma uncontrolled by medical therapy which meets at least one of the following criteria:
- Failed one or more incisional intraocular glaucoma surgeries (e.g., glaucoma filtering surgery or tube shunt)
- Failed one or more cilioablative procedures (e.g., cryotherapy, cyclodiode therapy)
- Have any other condition (e.g., conjunctival scarring, uveitis) in which a conventional incisional glaucoma surgery like trabeculectomy would be more likely to fail than for a person with uncomplicated primary open-angle glaucoma
Show all 10Show fewer
- Under present-day criteria subject is a candidate for glaucoma surgery
- Intraocular pressures of the eye above or equal to 25 mmHg with or without medication
- The angle should be grade 3 in at least the 180º superior and not less than grade 2 at any level of the angle
- Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
Who cannot join
- Subject diagnosed with primary angle-closure glaucoma (PACG)
- Subject diagnosed with normal-tension glaucoma (NTG)
- Subject diagnosed with secondary glaucoma
- Subject diagnosed with neovascular glaucoma
- Patient eyes with no light perception vision
- Patient eyes with the need for a combined glaucoma procedure or anticipated need for additional ocular surgery or retinal laser procedure within the 6-month follow-up period
Show all 14Show fewer
- Patient eyes that have failed laser trabeculoplasty but have not met the stated inclusion criteria
- The subject has best-corrected visual acuity (BCVA) worse than 20/200 in the non-study eye
- Subject consumes the anti aggregating or anticoagulant and cannot suspend the use at least four days prior to the procedure, and antiplatelet drugs one week before
- The subject is diagnosed with glaucoma-related to other comorbidities (especially neovascular glaucoma, inflammatory glaucomas, glaucomas associated with hemorrhages and pseudoexfoliation)
- Subject with inadequate space in the anterior chamber and/or angle as determined by slit-lamp examination and gonioscopy
- The subject is diagnosed with active anterior segment intraocular inflammation
- The subject is obligated to previous participation in another study with any investigational drug or device within the past 30 days
- Subject is pregnant
Trial locations and contacts
1 site in 1 country.
About this study
The HANITA Glaucoma Filtration Device is intended to reduce intraocular pressure in glaucoma patients where medical and conventional surgical treatments have failed.
Read the detailed description
Study Design:
This study is a prospective, single-arm single-center, open-label study.
Study population:
Men and women diagnosed with open-angle glaucoma who require glaucoma surgery procedures that meet the inclusion/exclusion criteria and provide written informed consent will be enrolled in the study.
Enrollment:
A total of 30 subjects will be enrolled:
15 patients will be implanted according to procedure 1 (see section 8.7), at completion additional 15 patients will be implanted according to procedure 2 (see section 8.7)
Investigational sites:
One (1) center will participate in this study.
Duration of Subject participation:
Completion of active enrolment is anticipated to last approximately 6 months. The primary endpoint will be achieved when the final study subject has completed 6 months follow-up.
Study Group:
A single study group. This is a single-arm design; there is no control device in this study.
Visits \& Procedures Pre-operative visit: 0-3 months prior to the implantation procedure. The visit will include the subject's qualification assessment for inclusion/exclusion criteria as described above. Informed consent must be signed.
Complete anamnesis will be taken including the subject's medical complaints, medical history, and medication use. Ophthalmic examinations as well as ultrasound biomicroscopy.
Surgical procedure: Procedure will be performed under anesthesia (at physician discretion) and a Hanita shunt will be implanted.
Follow-up: All subjects will have regular follow-up visits at 1 and 7 days and on 1, 3, and 6 months post-implantation. 1-year post-operative evaluation is optional at the sponsor's discretion. All postoperative visits will include a complete ophthalmic examination,
- Conditions
- Glaucoma
- Being tested
- Hanita Glaucoma shunt Ver.3.2
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hanita Glaucoma shunt Ver.3.2Device
The procedure will be performed under anesthesia (at physician discretion) and a Hanita shunt devce will be implanted.
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | Hanita Glaucoma shunt Ver.3.2 Receives: Device: Hanita Glaucoma shunt Ver.3.2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
VISUAL ACUITY
- Distance (far) manifest refraction and the testing distance used will be recorded on the case report forms. Manifest refraction will be determined using the maximum plus for best visual acuity method. The distance manifest refraction will be done with a distance adjusted chart but not less than 4 meters. The actual manifest refraction distance will be noted on the case report forms.
Visual acuity will be measured with ETDRS format charts for distance and near. Results will be recorded in a LogMar scale.
Measured: 1 year
SLIT LAMP EXAM
The slit lamp exam will include the measurement of aqueous cell and flare, and the measurement of corneal edema by a standard grading system. It will also include an evaluation for the presence of pupillary irregularities, iris atrophy and pigment dispersion. A gonioscopic exam using a consistent grading system at each site will also be conducted.
For the evaluation of aqueous cells and flare, use a slit lamp beam 0.3 mm wide and 1 mm high, and use the following grading:
Cells none (0) = no cells seen trace (+1) = 1-5 cells seen mild (+2) = 6-15 cells seen moderate (+3) = 16-30 cells seen severe (+4) = > 30 cells seen
Flare none (0) = No Tyndall effect trace (+1) = Tyndall effect barely discernible mild (+2) = Tyndall beam in anterior chamber is mildly intense moderate (+3) = Tyndall beam in anterior chamber is moderately intense severe (+4) = Tyndall beam is severely intense. The aqueous has a white and milky appearance.
Measured: 1 year
MEASUREMENT OF INTRAOCULAR PRESSURE
Intraocular pressure will be measured using Goldmann applanation tonometry or other validated methods.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start30 Jun 2015
- Primary completion15 Nov 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanita Lenses
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796883
- Sponsor's protocol ID
- HGS-01
- Status last verified
- Feb 2022
- First submitted
- 10 Mar 2021
- Last updated
- 2 Mar 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 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study for Assessing the Safety of Hanita Glaucoma Shunt in Glaucoma Patients
- ClinicalTrials.gov ID
- NCT04796883
- Acronym / sponsor ID
- HGS-01
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hanita LensesIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2015 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 15 Mar 2021 (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 HANITA Glaucoma Filtration Device is intended to reduce intraocular pressure in glaucoma patients where medical and conventional surgical treatments have failed.
Detailed description
Study Design:
This study is a prospective, single-arm single-center, open-label study.
Study population:
Men and women diagnosed with open-angle glaucoma who require glaucoma surgery procedures that meet the inclusion/exclusion criteria and provide written informed consent will be enrolled in the study.
Enrollment:
A total of 30 subjects will be enrolled:
15 patients will be implanted according to procedure 1 (see section 8.7), at completion additional 15 patients will be implanted according to procedure 2 (see section 8.7)
Investigational sites:
One (1) center will participate in this study.
Duration of Subject participation:
Completion of active enrolment is anticipated to last approximately 6 months. The primary endpoint will be achieved when the final study subject has completed 6 months follow-up.
Study Group:
A single study group. This is a single-arm design; there is no control device in this study.
Visits \& Procedures Pre-operative visit: 0-3 months prior to the implantation procedure. The visit will include the subject's qualification assessment for inclusion/exclusion criteria as described above. Informed consent must be signed.
Complete anamnesis will be taken including the subject's medical complaints, medical history, and medication use. Ophthalmic examinations as well as ultrasound biomicroscopy.
Surgical procedure: Procedure will be performed under anesthesia (at physician discretion) and a Hanita shunt will be implanted.
Follow-up: All subjects will have regular follow-up visits at 1 and 7 days and on 1, 3, and 6 months post-implantation. 1-year post-operative evaluation is optional at the sponsor's discretion. All postoperative visits will include a complete ophthalmic examination,
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Device: Hanita Glaucoma shunt Ver.3.2Hanita Glaucoma shunt Ver.3.2 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject is between 40 and 80 years of age
- Subject diagnosed with primary Open-angle glaucoma
- Subject is Diagnosed with glaucoma uncontrolled by medical therapy which meets at least one of the following criteria:
- Failed one or more incisional intraocular glaucoma surgeries (e.g., glaucoma filtering surgery or tube shunt)
- Failed one or more cilioablative procedures (e.g., cryotherapy, cyclodiode therapy)
Key exclusion criteria (14 listed)
- Subject diagnosed with primary angle-closure glaucoma (PACG)
- Subject diagnosed with normal-tension glaucoma (NTG)
- Subject diagnosed with secondary glaucoma
- Subject diagnosed with neovascular glaucoma
- Patient eyes with no light perception vision
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 |
|---|---|---|
| Hanita Glaucoma shunt Ver.3.2The procedure will be performed under anesthesia (at physician discretion) and a Hanita shunt devce will be implanted. | Device | single arm |
Primary outcome
VISUAL ACUITY
Time frame: 1 year
• Distance (far) manifest refraction and the testing distance used will be recorded on the case report forms. Manifest refraction will be determined using the maximum plus for best visual acuity method. The distance manifest refraction will be done with a distance adjusted chart but not less than 4 meters. The actual manifest refraction distance will be noted on the case report forms. Visual acuity will be measured with ETDRS format charts for distance and near. Results will be recorded in a LogMar scale.
SLIT LAMP EXAM
Time frame: 1 year
The slit lamp exam will include the measurement of aqueous cell and flare, and the measurement of corneal edema by a standard grading system. It will also include an evaluation for the presence of pupillary irregularities, iris atrophy and pigment dispersion. A gonioscopic exam using a consistent grading system at each site will also be conducted. For the evaluation of aqueous cells and flare, use a slit lamp beam 0.3 mm wide and 1 mm high, and use the following grading: Cells none (0) = no cells seen trace (+1) = 1-5 cells seen mild (+2) = 6-15 cells seen moderate (+3) = 16-30 cells seen severe (+4) = > 30 cells seen Flare none (0) = No Tyndall effect trace (+1) = Tyndall effect barely discernible mild (+2) = Tyndall beam in anterior chamber is mildly intense moderate (+3) = Tyndall beam in anterior chamber is moderately intense severe (+4) = Tyndall beam is severely intense. The aqueous has a white and milky appearance.
MEASUREMENT OF INTRAOCULAR PRESSURE
Time frame: 1 year
Intraocular pressure will be measured using Goldmann applanation tonometry or other validated methods.
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 2 Mar 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 Hanita Glaucoma shunt Ver.3.2 in people with Glaucoma, run by Hanita Lenses at 1 site in Spain.
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 14 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 2 Mar 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 Spain. 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?
VISUAL ACUITY (time frame: 1 year). The study lists 3 primary outcomes in all. 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 2 Mar 2022.