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

NCT04796883 | Completed

• 1 other identifier: HGS-01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  1 year

• MEASUREMENT OF INTRAOCULAR PRESSURE

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

  1 year

Study Arms (1)

single arm

EXPERIMENTAL

Hanita Glaucoma shunt Ver.3.2

Device: Hanita Glaucoma shunt Ver.3.2

Interventions

Hanita Glaucoma shunt Ver.3.2 DEVICE

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

single arm

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hanita Lenses: lead

Study Sites (1)

VISSUM

Madrid, Spain

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 15, 2021
• Study Start: June 30, 2015
• Primary Completion: November 15, 2021
• Study Completion: November 15, 2021
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

ES (1)