Status:
TERMINATED
Study of a Novel Interposition Supraciliary Implant in Patients With Open Angle Glaucoma (SAFARI 2)
Lead Sponsor:
Ciliatech
Collaborating Sponsors:
Clinchoice Inc
Conditions:
Glaucoma, Open-Angle
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
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 patie...
Detailed Description
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 ther...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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 criteria
- Patient:
- 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
- Patient with a known allergy to any of the constituents of the products used in this study
- 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
- Presenting with major traumatic glaucoma or neovascular glaucoma or iridocorneal endothelial syndrome (ICE syndrome)
- Having had a non-surgical operational treatment (ultrasound, cyclophotocoagulation, etc.)
- Having had eye surgery (other than glaucoma) less than 6 months ago
- Closed angle, grade 1 or 2 Schafer OAG
- 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
- 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
Exclusion
Key Trial Info
Start Date :
April 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 26 2024
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04770324
Start Date
April 23 2021
End Date
July 26 2024
Last Update
October 1 2025
Active Locations (1)
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1
Malayan Center
Yerevan, Armenia, 0033