Evaluation Of An Electroporation-Based Device For Dry Eye Disease: A Prospective Clinical Study

This study evaluates the efficacy and safety of JETT MEDICAL, an electroporation-based device, in improving symptoms and objective ocular parameters in patients with Dry Eye Disease (DED). Electroporation, a novel approach in ophthalmology, temporarily increases cell membrane permeability, facilitating hydration and nutrient exchange, potentially stabilizing the tear film and improving ocular surface quality.

This prospective, single-center clinical study was conducted in France, assessing patients with moderate to severe DED who had previously shown limited response to conventional therapies.

Eligible patients (Ocular Surface Disease Index, OSDI >13 or 5-item dry eye questionnaire, DEQ-5 >6) underwent three weekly treatment sessions using JETT MEDICAL. The procedure involved a silver flat applicator with gel-based conduction. Inclusion criteria were adults with moderate to severe DED and OSDI score >13. Exclusion criteria included active ocular infection, recent ocular surgery, and use of contact lenses. Primary outcome measures included changes in OSDI and DEQ-5 scores. Secondary endpoints included Tear Break Up Time (TBUT), Interblink Intervals (IBI), Ocular Protection Index (OPI), Schirmer test, meibography for gland atrophy, corneal/conjunctival staining, and epithelial mapping (OCT).

Significant improvements were observed in OSDI and DEQ-5 scores. Mean DEQ-5 scores decreased from 12.2 (SD 3.4) at baseline to 9.7 (SD 3.59) at day 7, and 8.7 (SD 3.95) at 1 month (p<0.001). Median OSDI scores improved from 37.05 (IQR 24.43) at baseline to 18.75 (IQR 30.73) at day 7, and 21.52 (IQR 22.9) at 1 month (p=0.005). Meibomian gland atrophy showed improvement, with median values decreasing from 30.0 (IQR 12.5) to 27.0 (IQR 14.5) post-treatment (p=0.002). No significant changes were observed in TBUT, IBI, or OPI. Further statistical validation is underway for epithelial mapping and corneal staining data

JETT MEDICAL offers a promising non-invasive alternative for DED management, demonstrating significant symptom relief with potential objective ocular surface improvements. While tear film and some glandular function changes remain inconclusive, epithelial remodeling and meibomian gland improvement may be early markers of treatment efficacy. Future studies with larger cohorts and longer follow-up periods are required to validate these findings and optimize treatment protocols.