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CompletedNCT04796883Updated Mar 2, 2022

A Study for Assessing the Safety of Hanita Glaucoma Shunt in Glaucoma Patients

An interventional study of Hanita Glaucoma shunt Ver.3.2 in Glaucoma, sponsored by Hanita Lenses. Completed at 1 site in Spain. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-03-02.

Sponsored by Hanita Lenses · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years 8 months after the study started (first participant enrolled Jun 2015, registered Mar 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
40 Years to 80 Years
Sex
All
01

Study summary

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,

02

Conditions studied

  • Glaucoma

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03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 16 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Hanita Lenses is the lead sponsor of 13 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    single arm

    Hanita Glaucoma shunt Ver.3.2

    Device: Hanita Glaucoma shunt Ver.3.2

Interventions

  • DeviceHanita Glaucoma shunt Ver.3.2

    The procedure will be performed under anesthesia (at physician discretion) and a Hanita shunt devce will be implanted.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

  2. 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.

    Time frame: 1 year

  3. MEASUREMENT OF INTRAOCULAR PRESSURE

    Intraocular pressure will be measured using Goldmann applanation tonometry or other validated methods.

    Time frame: 1 year

07

Study locations

1 site
  • VISSUM
    Madrid, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04796883
Lead sponsor
Hanita Lenses
Responsible party
Sponsor
First posted
Mar 15, 2021
Start date
Jun 30, 2015
Primary completion
Nov 15, 2021
Completion
Nov 15, 2021
Last update
Mar 2, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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