V. Kumar,1,2 M. Frolov,1 E. Bozhok,2 G. Dushina1 1 Department of Ophthalmology, People’s friendship university of Russia, Moscow, Russian Federation 2 Ophthalmic Unit of Skhodnya city hospital, Moscow province, Russian Federation A novel stainless steel spiral intracanalicular device for Schlemm’s canal dilation to treat open-angle glaucoma Financial disclosure: The university is patent holder of the device Innovative educational program of PFUR 1

ICD Material: Medical grade (316) stainless steel wire (0.05mm) Technical characteristics: Spiral, curvature as of SC, length varies from 5 to 7 mm, inner lumen diameter – 0.2mm, outer -0.3mm. The wire loops of end parts are closely located, in the central part they are apart from each other by 0.5 to 1 mm. ICD size in comparison to 50 kopek coin Patented as useful model in Russian Federation. Actual size of ICD ICD – schematic Purpose To evaluate the efficacy of a novel intracanalicular device (ICD) in decreasing intraocular pressure (IOP) in patients with open angle glaucoma (OAG).

A prospective, non-randomized, interventional case series Methods and material A prospective, non-randomized, interventional case series Total 10 cases (10 eyes) of OAG: 4 male, 6 – female; avg. age: 70.3+/-5.5 yrs (4 cases-OAG; 4 cases – concomitant pathology; 1 case – previous glaucoma surgery; 1 case – secondary glaucoma with open angle) Inclusion criteria: OAG with high IOP on maximum hypotensive medication(s). Conditions interfering with reliable tonometry by Maklakov method Insufficient gonioscopic visualization of the trabecular meshwork (TM) Cases having macro perforation of TM in exposed SC area Follow-up period < 3 months Exclusion criteria: Previous cataract or glaucoma surgery – not exclusion criteria Main outcome measures: Primary - IOP change. Secondary - complication rate, additional glaucoma medication, need for surgical revision Criteria for success : Complete success: decrease in IOP >25% or IOP 18 mmHg or less without medication Partial success - decrease in IOP >25% or IOP 18 mmHg or less with medication

Methods and material Maklakov’s applanation tonometry Tonometry Tonometer – 10g. Imprint

It is an ab externo procedure. Surgical steps are as follows: Surgical technique It is an ab externo procedure. Surgical steps are as follows: Dissection of conjunctival and superficial and deep scleral flaps. Exposure of Schlemm’s canal (SC) without creating a window in descemete membrane. Viscocanalostomy and SC dilation with microprobes. Insertion of ICD. Watertight wound closure. Surgical technique

Results Mean preoperative IOP - 26.3+/-6.4mmHg (range:18-35) Mean number of topical medication - 2.5+/-0.7 (range: 2-4) Mean follow-up – 15.8+/-3.8 weeks IOP change: Mean IOP - 11+/-3.8mmHg IOP decrease - 15.3 mmHg (56.8%) Range - 6 -19 mmHg; (p<0.000004). Glaucoma Decrease in mean number - 1.8 (72%) medication(s) of medication from 2.5 to 0.7 Success rate Complete success -60% (6 cases) after 3 months: Partial success -40% (4 cases) Observations Easy implantation during surgery: Micro-perforation of TM - 2 cases Difficulty during insertion - 1 case Observations Low diffuse bleb - 3 cases (30%) in postoperative period: Transitory increase in IOP - 1 case YAG laser goniopuncture - 1 case

No inflammation at insertion site was observed during gonioscopy. Results Gonioscopy: ICD in SC - 9 cases Dislocation of device - 1case Blood Dislocated body of the stent Case N5. 1st day after surgery. Blood reflux in SC is observed. Case N7. 1st day after surgery. ICD is clear, no blood reflux. No inflammation at insertion site was observed during gonioscopy. Follow-up 4 weeks. ICD is clear. No sign of inflammation. Gonioscopy after 4.5 months. ICD is clear. No sign of inflammation. Conclusion In eyes with OAG, ICD decreases IOP significantly by keeping the SC opened.