The purpose of this study is to evaluate the safety and effectiveness of implanting 2 novel interposition supraciliary implant as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) who have failed at least one class of topical medical therapy
22 patients will be included in this 36 months interventional study. All patients shall be indicated for glaucoma surgery alone (not combined with cataract), and will undergo incisional glaucoma therapy, including a novel simplified surgical technique allowing placement of 2 interposition supraciliary permanent devices. Several patient data like IOP, visual capacity or associated pharmacological treatments will be recorded pre and post-operatively all along the follow-up. Purpose is to ensure device safety, and verify IOP and associated pharmacological treatment reduction after surgery, and evolution along follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Surgical placement of 2 interposition supraciliary implant in the supraciliary space
Malayan Center
Yerevan, Armenia
Assess post-op IOP reduction
Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20%
Time frame: 6, 12, 24, 26, 48, 60 months
Assess post-op IOP clinical success
Proportion of Eyes With Intraocular Pressure (IOP) \< 21 mmHg
Time frame: 6, 12, 24, 26, 48, 60 months
Evaluate implant and surgical procedure safety
To evaluate the safety of the implant and the surgical procedure: To describe of all adverse events (AEs) throughout the study
Time frame: up to 60 months
Compare clinical success rate
To compare the clinical success rate at 6, 12, 24, 36, 48 and 60 months to that of the Supraflow study in Armenia
Time frame: Up to 60 months
assess rate of patients with a reduction in post-op IOP with or without combined treatments
To describe the rate of patients with at least a 20%, 25%, 30% and 40% reduction in postoperative IOP, with or without combined medical treatments, at each visit
Time frame: Up to 60 months
assess rate of patients with IOP less than or equal to 18 mmHg and less than or equal to threshold
To describe the rate of patients with a post-operative IOP ≤ 18 mm Hg; as well as for a threshold ≤ 16 mm Hg
Time frame: Up to 60 months
assess the rate of patients with a reduction of IOP post-operatively
To describe the rate of patients with a reduction of post-operative IOP of least 5 mmHg
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Time frame: Up to 60 months
assess the mean and median reduction in IOP
To describe the mean and median reduction in IOP between the baseline and each subsequent assessment
Time frame: Up to 60 months
assess the rate of patients without medical treatment for glaucoma
To describe the rate of patients without medical treatment for glaucoma at each visit
Time frame: Up to 60 months
average rate of IOP reduction
describe the average rate of IOP reduction vs baseline
Time frame: Up to 60 months
assess IOP stability
To describe IOP stability over at each visit, without further eye surgery, and without the use of anti-glaucoma or adjunctive therapies such as goniopuncture or needling
Time frame: Up to 60 months
assess the rate of patients with no filtering bleb
To describe the rate of patients with no filtering bleb
Time frame: Up to 60 months
Average number of adjunctive therapies and follow up visits
To describe the average number of adjunctive therapies (needling, goniopuncture) and follow up visits (including those which were scheduled and which were not scheduled in the protocol)
Time frame: Up to 60 months
Evaluate surgical procedure
To evaluate the surgical procedure (duration of operation, ease of implantation)
Time frame: Day 0, day of surgery
Assess patient satisfaction
To describe patient satisfaction following surgery based on criteria of pain, discomfort and deterioration in visual acuity
Time frame: Up to 60 months
Assess changes in quality of life
To describe changes in quality of life (EQ5D)
Time frame: Up to 60 months
Follow the progression of glaucoma and potential complications
To describe the progression of the glaucoma at 6, 12, 24, 36, 48 and 60 months, and any complications
Time frame: Up to 60 months