V. Kumar 1,2, M. Frolov 1, I. Shepelova 1,2 Department of ophthalmology, People's friendship university of Russia, Moscow, Russian Federation 1 ; Ophthalmic.

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V. Kumar 1,2, M. Frolov 1, I. Shepelova 1,2 Department of ophthalmology, People's friendship university of Russia, Moscow, Russian Federation 1 ; Ophthalmic unit of Skhodnya city hospital, Moscow province 2 Long term results of surgical treatment of refractory glaucoma using an original stainless steel glaucoma device Innovative educational program of PFUR Financial disclosure – PFUR is the patent holder for this device

Purpose: To analyze long term results of surgical treatment of refractory glaucoma using an original stainless steel glaucoma device. Methods and material: Study period: Jan,2008 – July, patients (20 eyes) - 10 male and 10 female patients, avg. age: /- 6.8 yrs. (55-81 yrs.). –Painful terminal stage of open angle glaucoma – 8 cases (40%) –Failed previous glaucoma surgery – 8 cases (40%) –Post-uveal secondary glaucoma – 1 case ( 5%) –Neovascular glaucoma – 3 cases (15%) Mean intraocular pressure (IOP), – 34+/-5.8 mmHg measured by Maklakov method (range: mmHg) Mean number hypotensive medications – 2.6+/-0.5 The device, Patent of the Russian Federation №91863 Outcome measures : IOP change, visual acuity, additional hypotensive medication use and need for repeat surgery. Success rates were evaluated at each follow-up visit as per the guidelines of World Glaucoma Association for clinical surgical trials.

Surgical technique: Under fornix based conjunctival flap, app mm away from limbus and parallel to it, a band of sclera (1.5 X 1.0 mm X 90-95% full sclera thickness) was dissected and excised. Device made from 0.25 mm thick medical grade stainless steel wire was inserted into anterior chamber through 1.5 mm wide parasynthesis at the base of scleral groove and its other end was fixed to the posterior lip of scleral groove with suture.

Results: Success rate: Complete success - 12 cases (60%) Partial success - 4 cases (20%) Failure - 4 cases (20%) IOP change: Mean IOP decreased from 34+/-5.8 to /-3.9 mm Hg (p= ) 67.5% IOP drop from baseline Use of hypotensive medications: mean number decreased from 2.6+/-0.5 to 1.1+/-0.3 (p=0.0002). Device explantation: In one case (5%) after 2.5 years, device eroded through the conjunctiva and was removed. A filtering surgery was performed in this cases to control IOP. Visual acuity: useful vision was maintained in all cases. Relieve from pain: all cases with painful eyes were free from pain at long term follow-up.

Results:

Conclusions: Implantation of an original stainless steel glaucoma drainage device into anterior chamber angle in long terms effectively decreases IOP in cases with refractory glaucoma, relieves patients of pain and can serve as an alternative to enucleation or evisceration of eye ball.