None listed
Conditions
Brief summary
Assess the intraocular pressure (IOP) reduction induced by the STARflo glaucoma implant in eyes with open angle glaucoma. Absolute success is defined as an IOP < 21mmHg and > 5mmHg with a minimum 20% IOP reduction from baseline without the need for glaucoma medication. Qualified success is defined as an IOP < 21mmHg and > 5mmHg with a minimum 20% IOP reduction from baseline with the concomitant use of glaucoma medication. This is a prospective, single centre study of the CE marked and TGA approved STARflo glaucoma implant. Patients with open angle glaucoma requiring surgical reduction of IOP will be screened for suitability for inclusion in the study. Following implantation of the STARflo, participants will be followed for a minimum 12-months.
Interventions
Implantation of STARflo glaucoma implant into the anterior chamber and suprachoroidal space. The STARflo glaucoma implant (v2.0) is a 5mm x 8mm silicone device made using a patented porous biomatrix designed to facilitate the flow of aqueous fluid through it and enhance compatibility with surrounding tissues. Implantation is performed via an external approach under local anaesthesia and is anticipated to take 45 - 60 minutes.
Sponsors
South East Sydney Illawarra Area Health Service
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males or females 18 years of age or greater. 2. Diagnosis of open angle glaucoma in the study eye. 3. Concurrent treatment with ocular hypotensive medications in the study eye and/or oral acetazolamide. 4. Documented IOP > or = 21 mmHg in the study eye on medical therapy at two visits at least 48 hours apart, within six weeks prior to study entry and at day 0. 5. Glaucoma progression despite current medical and/or laser trabeculoplasty treatment OR intolerance of current medical and/or laser trabeculoplasty treatment OR inadequate IOP reduction with medical and/or laser trabeculoplasty treatment. 6. Patient willing and able to undergo implantation of the STARflo in the study eye and return for scheduled study-related examinations.
Exclusion criteria
1. Diagnosis of secondary open angle glaucoma where STARflo implant is considered contraindicated (e.g., traumatic, uveitic, or neovascular glaucoma). 2. Diagnosis of angle-closure glaucoma or angle-closure suspect Clinically significant corneal disease (e.g., corneal dystrophy, corneal graft) 3. Any previous ophthalmic surgery in the same eye quadrant other than trabeculectomy, trabeculoplasty, and cataract surgery within 3 months prior to study entry. 4. Laser trabeculoplasty within three months prior to study. Active vascular or inflammatory retinopathy (diabetes, hypertension, uveitis) 5. Intra-ocular inflammation or infection within six months prior to study 6. Evidence of crystalline lens subluxation or luxation
Outcome results
None listed