ESCRS - PO252 - Efficacy Of Novel Tixel Treatment In Reducing Dry Eye Signs And Symptoms, A Prospective Multicentre Clinical Trial

Efficacy Of Novel Tixel Treatment In Reducing Dry Eye Signs And Symptoms, A Prospective Multicentre Clinical Trial

Published 2022 - 40th Congress of the ESCRS

Reference: PO252 | Type: Free paper | DOI: 10.82333/cr7w-js82

Authors: Sunil Shah* 1 , Debarun Dutta 2 , Ludger Hanneken 3 , Marisa Martins 3 , Roberto Mendes 3 , Shehzad Naroo 4

1Midlands Eye,Midlands Eye,Sollihul,United Kingdom, 2Health and Life Sciences,Aston University,Birmingham,United Kingdom, 3Vallmedic Vision,Vallmedic Vision,Andorra,Andorra, 4Health and Life Sciences,Aston University ,Birmingham ,United Kingdom

Purpose

To determine the efficacy of a fractional skin rejuvenation system (Tixel) on alleviating dry eye signs and symptoms in a prospective, multicentre clinical trial.

Setting

Multicentre clinical trial 

Methods

A prospective, cross-sectional, multicentre, controlled study was conducted at Birmingham, UK; Andorra and Cambodia. Participants with dry eye symptoms, OSDI score >13, NIBUT  ≤ 10 seconds were recruited. Three Tixel treatments were conducted at 2-weeks intervals (40 peri-orbital non-ablative microthermal delivery of heat for 8 milliseconds and 400-micrometer protrusion (0.18 millijoules/point). Participants were followed up at the baseline, 2-weeks after 1st (visit 2), 2nd (visit 3) and 3rd treatment (visit 4), and 6 weeks after 3rd treatment (visit 5). Detailed dry eye assessments including OSDI questionnaires, non-invasive break-up time (NIBUT) and tear osmolarity were investigated.

Results

A total of 120 participants were recruited, the average age was 57±13.8 years, among them 87  were females. By the time of reporting 109 participants completed visit 4 and 78 participants completed visit 5. Ocular dryness by OSDI score after visit 2, 3, 4, and 5 improved by 10.6.2±4.7, 14.4±6.0, 18.8±8.9, 20.6± 9.6 (P<0.001) respectively, which are higher than the minimal clinically important difference (MCID). NIBUT improved 2.2±0.9 in Birmingham centre, 2.4±1.1 in Cambodia, 6.1±2.9 in Andorra centre (P<0.05. Tear osmolarity for right and left eye reduced from 298.2±14.6 and 298.4±14.4 to 294.9±8.5 (P=0.090) and 295.6±8.7 (P=0.041) mOsm/L respectively. 

Conclusions

Tixel treatments significantly reduce key clinical parameters of dry eye signs and symptoms when followed up to 3 months post-treatment.