A NEW INTRACANALICULAR DEVICE TO TREAT OPEN-ANGLE GLAUCOMA KUMAR V., FROLOV M.A., BOJHOK E.V., DUSHINA G.N. A NEW INTRACANALICULAR DEVICE TO TREAT OPEN-ANGLE GLAUCOMA (PRELIMINARY RESULTS) Purpose To evaluate the efficacy of a new intracanalicular device (ICD) in decreasing intraocular pressure (IOP) in patients with open-angle glaucoma (OAG). Setting Department of ophthalmology, People’s friendship university of Russia, Moscow Ophthalmic unit of Skhodnya city hospital, Moscovskaya oblast , Russian Federation. Innovative educational program of PFUR Financial disclosure - none

Methods and material A prospective, non-randomized, interventional case series Total 10 cases (10 eyes) of OAG Male –5 patients (50%), female –5 patients (50%); avg. age: 70.2+/-1.7 yrs Study period: October 2012 - December 2012 Exclusion criteria: Conditions interfering with reliable applanation tonometry by Maklakov method Peripheral anterior synechia or insufficient gonioscopic visualization of the trabeculum Minimum follow-up period less than 3 months IOP change, complication rate, additional glaucoma medication, need for surgical revision Main outcome measures: 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

Surgical technique It is an ab externo procedure. Surgical steps are as follows: Dissection of conjunctival flap, 1/2 thickness superficial (5X5 mm) and deep (3X3 mm) scleral flaps upto ciliary body as for viscocanalostomy. Exposure of Schlemm’s canal (SC) without creating a window in descemete membrane. Viscocanalostomy and mechanical dilation of SC with microprobes. Insertion of ICD. Watertight wound closure. Surgical technique (Video-insertion technique for ICD.wmv) ICD size in comparison to 50 kopek coin Actual size of ICD The device has been patented in Russia. Patent № 130840 dated 10 August, 2013.

Results Mean preoperative IOP - 23.3mmHg Mean number of topical medication - 2.5 IOP change: Mean IOP decrease - 10.6 mmHg (44.1%) Range- 4.7 to 16.8 mmHg; (p<0.05). Glaucoma Decrease in mean number - 2.2 (88%) medication(s) of medication - from 2.5 to 0.3 (p<0.05). Success rate Complete success -70% (7 cases) after 3 months: Partial success -30% (3 cases) Observations All surgical steps to implant ICD into SC were easy to during surgery: perform. Micro-perforation of trabecular meshwork in areas other than exposed SC - 2 cases Complete insertion of the device into SC - 5 cases Partial insertion of the device - 5 cases. Observations Low diffuse bleb - 5 cases (50%) in postoperative period: Transitory increase in IOP - 2 cases YAG laser goniopuncture - 1 case Gonioscopy – ICD in SC - 9 cases Dislocation of device - 1case

No inflammation in any of the cases was observed Results No inflammation in any of the cases was observed Pic.1b. Patient B. after 7 days. Blood has been dissolved spontaneously. No sign of inflammation. Pic.1a. Patient B. 65/M. 1ST day after operation. Some blood is seen in SC. Pic.2a. Patient A. 73/F. ICD in the SC. Follow-up 1 week. Pic. 2b. Same pt. A. Follow-up 4.5 months. The device is in SC. No sign of inflammation.

Conclusions In eyes with OAG, ICD decreases IOP significantly by keeping the SC open. The technique of ICD implantation is simple, learning curve is short, and complications are few and easily manageable.