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

Hanita Lenses

Status

Completed

Conditions

Glaucoma

Treatments

Device: Hanita Glaucoma shunt Ver.3.2

Study type

Interventional

Funder types

Industry

Identifiers

NCT04796883

HGS-01

Details and patient eligibility

About

The HANITA Glaucoma Filtration Device is intended to reduce intraocular pressure in glaucoma patients where medical and conventional surgical treatments have failed.

Full 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,

Enrollment

16 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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

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