1. 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

2. 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).

3. 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

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

5. 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

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

7. No inflammation at insertion site was observed during gonioscopy.
Results
Gonioscopy:
ICD in SC 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.