1. 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

2. 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 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

3. 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 № dated 10 August, 2013.

4. Results Mean preoperative IOP - 23.3mmHg
Mean number of topical medication - 2.5
IOP change: Mean IOP decrease mmHg (44.1%)
Range to 16.8 mmHg; (p<0.05).
Glaucoma Decrease in mean number (88%)
medication(s) of medication - from 2.5 to (p<0.05).
Success rate Complete success % (7 cases)
after 3 months: Partial success % (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 cases
Complete insertion of the device into SC - 5 cases Partial insertion of the device cases.
Observations Low diffuse bleb 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

5. 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.

6. 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.