EFFICACY OF NOVEL TIXEL TREATMENT IN REDUCING DRY EYE SIGNS AND SYMPTOMS, A
PROSPECTIVE MULTICENTRE CLINICAL TRIAL
Published 2022
- 26th ESCRS Winter Meeting
Reference: P198
| Type: Abstracts
| DOI:
10.82333/eezn-gz65
Authors:
Sunil Shah* 1
, Debarun Dutta 2
, Ludger Hanneken 3
, Roberto Mendes 3
, Mukesh Taneja 4
, Shehzad Naroo 5
1Midlands Eye,Midlands Eye,Birmingam ,United Kingdom;Optometry School,Aston University ,Birmingham,United Kingdom, 2Optometry School ,Aston University ,Birmingham ,United Kingdom, 3Vallmedic Vision,Vallmedic Vision,Andorra,Andorra, 4Khmer Sight Foundation Research Centre,Khmer Sight Foundation Research Centre,Phnom Penh,United Kingdom, 5Optometry School,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
Prospective, cross-sectional, multicentre, controlled clinical setting
Methods
The 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 298.3±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.
Conclusion
Tixel treatments significantly reduce key clinical parameters of dry eye signs and symptoms when followed up to 3 months post-treatment.