Study of a Novel Interposition Supraciliary Implant in Patients With Open Angle Glaucoma (SAFARI 2)
Megadott ok: All original protocol assessments through M36 were completed. M48/60 were amendment additions to assess long-term efficacy. A new SV22 device was developed, and all subsequent studies used it. Amendments reflected interest in outcomes, not safety.
Key facts
- Where
- Yerevan, ÖrményországSee the site
Where in Örményország
- Malayan centerYerevan, ÖrményországNo longer taking part
Trial details
- Who runs it
- Ciliatech
- Trial code
- NCT04770324
- Record updated
- 2025. október 1.
- Original description
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 therapyRead full original descriptionShow less
Monocentre, Non-Randomised Clinical Study Evaluating the Efficacy and Safety of 2 Supraflow® v1.3 Medical Devices in Glaucoma Surgery
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
Inclusion: Patient:; Patient ≥ 50 years old; Patient dated and signed the informed consent form to participate in the study at first visit; Eye:; Phakic, pseudophakic or aphakic eye; Has medically treated open-angle glaucoma (schaffer grade 3 and 4); The optimal medical treatment against glaucoma for this eye has failed i. Preoperative treatment ≥ 2 molecules with target IOP not reached despite medication, ii. or IOP ≥ 21 mmHg under treatment, iii. or patient not compliant with treatment, iv. or patient intolerant to treatment; Having undergone at most one filtration surgery (trabeculectomy, deep sclerectomy, viscocanalostomy) for more than 3 months; Having the indication for glaucoma surgery alone.
Exclusion: Patient with visual acuity of the contralateral eye greater than LogMar 0.3. If no problems are detected at three months post surgery on at least the first 10 patients included, the study monitoring committee may propose to relax this non-inclusion criterion by setting the visual acuity of the contralateral eye above LogMar 0.7; Having had a non-surgical operational treatment (ultrasound, cyclophotocoagulation, etc.); Having had eye surgery (other than glaucoma) less than 6 months ago; Patient with a known allergy to any of the constituents of the products used in this study; Presenting with major traumatic glaucoma or neovascular glaucoma or iridocorneal endothelial syndrome (ICE syndrome); Pre-existing ocular or systemic pathology that may cause post operative complications such as:; Clinically significant inflammation such as uveitis; Eye infection; Anterior segment neovascular disease; Severe dry eye syndrome; Patient:; Patient already included in another study; A person protected by law (temporary or permanent guardianship) or not capable of discernment; Eye; Presenting with inflammatory glaucoma; Presenting with congenital glaucoma; Closed angle, grade 1 or 2 Schafer OAG; Severe blepharitis; Retinopathy which can lead to neovascular complications in the anterior segment; Eye of axial length <20 mm; Eye with lens dislocation or subluxation.