JUN 09, 2022
The Systane iLux thermal pulsation treatment was assessed for its efficacy in treating dry eye disease by examining meibomian gland secretions (MGS) and tear breakup time (TBUT), Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire scoring, and Ocular Surface Disease Index (OSDI) scores.
This prospective, nonrandomized, open-label, multicenter study evaluated the efficacy of Systane iLux thermal pulsation in 60 eyes of patients with dry eye and meibomian gland dysfunction (MGD). The primary outcome measure was the mean MGS score based on the sum of 15 graded glands and the TBUT. The secondary measures were the SPEED questionnaire and OSDI scores. Efficacy of treatment was measured at 1 week and 1 month following treatment. Enrolled patients were already regularly using artificial tears. Patients were excluded from the study if they had a history of ocular surgery, isotretinoin use within the past year, inflammation within the past 3 months, cyclosporine A use within the past 2 months, contact lens wear, or use of any other topical medications within the 2 weeks prior to enrollment. Both eyes of each enrolled patient were treated until clear meibum was expressed across the lower eyelid or after 4 compression cycles.
Following iLux treatment patients achieved statistically significant improvement from baseline in both the primary and secondary efficacy outcomes at 1 week and 1 month after treatment. Mean MGS scores increased by at least 11 points on the 45-point scale and at each assessment. Mean TBUT increased more than 3 seconds in all eyes and at each assessment. Mean SPEED scores showed a change of –8.6 and OSDI scores showed a change of –26.3 at 1 week and –28.5 at 1 month.
Limitations to this study include lack of a control group and the unregulated use of at-home therapies including artificial tears, warm compresses, and lid hygiene. Both objective and subjective measurements were included; however, those assessing the objective measurements were aware of the treatment. The study also did not include any post-surgical patients and did not assess efficacy beyond 1 month.
The Systane iLux thermal pulsation treatment is an 8–10 minute in-office procedure that produced statistically significant and clinically relevant improvements in MGD and dry eye both at 1 week and 1 month following treatment.