Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
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Transcutaneous periorbital electrical stimulation in the treatment of dry eye.

PURPOSE: To evaluate efficacy and safety of transcutaneous application of electrical current on symptoms and clinical signs of dry eye (DE).

METHODS: 27 patients with DE underwent transcutaneous electrostimulation with electrodes placed onto the periorbital region of both eyes and manual stimulation with a hand-piece conductor moved by the operator. Each patient underwent 12 sessions of 22 min spread over 2 months, two sessions per week in the first month and one session per week in the second month. Ocular Surface Disease Index (OSDI) questionnaire, tear break-up time (TBUT), fluorescein staining of the cornea, Schirmer I test and adverse events were evaluated at baseline, at end of treatment and at 6 and 12 months.

RESULTS: OSDI improved from 43.0±19.2 at baseline to 25.3±22.1 at end of treatment (mean±SD, p=0.001). These effects were substantially maintained at 6-month and 12-month follow-up evaluations. Improvement of the values of TBUT was recorded for the right eye at the end of treatment (p=0.003) and found in the left eye after 12 months (p=0.02). The Oxford scores changed in both eyes at the end of treatment and at the 6-month evaluation (p<0.001), and in the right eye at the 12-month evaluation (p=0.035). Schirmer I improved significantly at the end of treatment in the left eye (p=0.001) and in both eyes at the 12-month evaluation (p=0.004 and p=0.039 for the left and right eye, respectively). A significant reduction of the use of tear substitutes was found at the end of treatment (p=0.003), and was maintained during the follow-up (p<0.001).No complications occurred and patients found the treatment satisfying.

CONCLUSIONS: Transcutaneous electrical stimulation was shown to improve DE, both subjectively and objectively, without any adverse effects and has the potential to enlarge the armamentarium for treating DE.

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