Status:
COMPLETED
A Study for Assessing the Safety of Hanita Glaucoma Shunt in Glaucoma Patients
Lead Sponsor:
Hanita Lenses
Conditions:
Glaucoma
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
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 tha...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 30 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04796883
Start Date
June 30 2015
End Date
November 15 2021
Last Update
March 2 2022
Active Locations (1)
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1
VISSUM
Madrid, Spain