Glaucoma implant trial halted early – what we know

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: Patient: 1. Patient ≥ 50 years old 2. Patient dated and signed the informed consent form to participate in the study at first visit Eye: 3. Phakic, pseudophakic or aphakic eye 4. Has medically treated open-angle glaucoma (schaffer grade 3 and 4) 5. 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 6. Having undergone at most one filtration surgery (trabeculectomy, deep sclerectomy, viscocanalostomy) for more than 3 months. 7. Having the indication for glaucoma surgery alone Exclusion criteria Patient: 1. 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 2. Patient with a known allergy to any of the constituents of the products used in this study 3. Patient already included in another study 4. A person protected by law (temporary or permanent guardianship) or not capable of discernment Eye 5. Presenting with inflammatory glaucoma 6. Presenting with congenital glaucoma 7. Presenting with major traumatic glaucoma or neovascular glaucoma or iridocorneal endothelial syndrome (ICE syndrome) 8. Having had a non-surgical operational treatment (ultrasound, cyclophotocoagulation, etc.) 9. Having had eye surgery (other than glaucoma) less than 6 months ago 10. Closed angle, grade 1 or 2 Schafer OAG 11. 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 12. Severe dry eye syndrome 13. Severe blepharitis 14. Retinopathy which can lead to neovascular complications in the anterior segment 15. Eye of axial length \<20 mm 16. Eye with lens dislocation or subluxation