Posters

Ocular magnetic neurostimulation as an innovative treatment for dry eye disease: initial results of a randomized, sham-controlled study

Poster Details

First Author: H.Avizemer ISRAEL

Co Author(s):    A. Bar   D. Zadok   E. Roditi   D. Varssano   E. Levinger   G. Kleinman     

Abstract Details

Purpose:

To evaluate the safety and effectiveness of the Ocular Magnetic Neurostimulation System (OMNS) for the management of severe dry eye disease (DED).

Setting:

1. Ophthalmology Dept., Edith Wolfson Medical Center, Holon, Israel. 2. Sackler Faculty of Medicine, Dept. of Ophthalmology, Tel Aviv University, Tel Aviv, Israel. 3. Ophthalmology Dept., Shaare Zedek Medical Center, Jerusalem, Israel. 4. Ophthalmology Dept., Cornea Unit, Tel Aviv Sourasky Medical Center, Israel.

Methods:

Subjects with severe DED were enrolled into this prospective, interventional, randomized, double-masked, sham-controlled ongoing study. Subjects were randomized equally to a control (sham) or active treatment group. A 10-minute OMNS treatment was administered to both eyes, one eye at a time. Follow-ups were conducted at 1, 4, 8, and 12 weeks post treatment. Signs and symptoms were assessed by corneal staining (NEI grading scale 0-15) and by the SPEED questionnaire, respectively. Safety measurements included treatment related adverse events (AE), BCVA, slit lamp findings and IOP measurement.

Results:

Of the 10 subjects, 4 were Sjögren's syndrome patients and 6 non-Sjögren's aqueous tear deficiency patients. Half of the patients were treated, and half received sham treatment. 4 weeks post treatment mean change from baseline in corneal staining score and symptom score showed an improvement of 2.1 points in the treated group vs. 1.0 point in the control group, and 18.7 points for the treatment group vs. 7.0 points for the control group, respectively. No treatment related AEs were observed.

Conclusions:

This interim analysis of 10 subjects (out of 40 planned subjects) demonstrated that OMNS treatment was safe and induced a greater improvement in both signs and symptoms of DED compared to the control group in a cohort of subjects with severe DED. Data collection is ongoing to further evaluate this innovative device as an adjunct in the management of DED.

Financial Disclosure:

receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented