Efficiency and Changes of Cytokines Expression in Tear After Intense Pulsed Light Treating Dry Eye Disease
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional

Summary: 
      The aim of the current study is to investigate changes of tear cytokines levels as well as
      the efficacy and the reduction of demodex infestation after OPT IPL treatment in patients
      with meibomian gland dysfunction-Associated demodicosis. The effect of OPT IPL will be
      examined in a study designed as a randomised controlled trial. In the study arm, subjects
      will undergo 4 treatment sessions, consisting of OPT IPL pulses immediately followed by
      meibomian gland expression (MGX). In the control arm, subjects will undergo the same
      treatments, except that the OPT IPL pulses will be disabled. For each subject, the duration
      of the study will be 2 months , as explained in the detailed description.
    

Detailed description: 
      All subjects will receive 4 treatments at 2 weeks intervals. In each treatment session, a
      subject allocated to the study group will be treated with Optimal pulsed technology intense
      pulsed light (OPT IPL) administered in the malar region, from tragus to tragus including the
      nose, 2-3 mm below the lower eyelids. Immediately following the OPT IPL administration, the
      subject will undergo meibomian gland expression (MGX) in both eyelids of both eyes. Subjects
      in the control arm will receive exactly the same treatment, except that the OPT IPL
      administration will be sham. A single follow-up will occur at 2 months after the baseline (or
      2 weeks after the 4th treatment session). At the follow-up, the changes in the outcome
      measures will be evaluated, and compared between the two arms.

      For each subject, the duration of the study will be 2 months: 1st treatment at baseline; 2nd
      treatment at 2 weeks after baseline; 3rd treatment at 4 weeks after baseline; 4th treatment
      at 6 weeks after baseline; and a single follow-up at 8 weeks after baseline).

      Statistically significant differences between the two arms will support the study hypothesis
      that IPL treatment is potentially reduce demodex counts and decrease levels of cytokines ,
      and relief to both signs and symptoms of dry eye disease.
    

Intervention name(s): OPT IPL; Sham OPT IPL; MGX
Intervention type(s): Device; Device; Procedure
Intervention description(s): Intense pulsed light (IPL) is a non-invasive and non-laser light treatment that is FDA-approved for various conditions in dermatology. Subjects will receive a total of 4 IPL treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications of 24 IPL pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression.; Sham Optimal pulsed technology intense pulsed light IPL will be implemented with an IPL device in which all light is blocked by a filter. Subjects will receive a total of 4 sham treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications of 24 sham pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression.; Meibomian gland expression (MGX) will be implemented by squeezing the meibomian glands with the aid of stainless steel jaeger lid plate positioned in the inferior fornix space between the tarsal and bulbar conjunctiva, and a cotton swab in another side.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized 1:1 to a study arm and a control arm. Subjects in the study arm will be treated with OPT IPL and meibomian gland expression. Subjects in the control arm will be treated with sham OPT IPL and meibomian gland expression.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Optimal pulsed technology intense pulsed light; meibomian gland dysfunction; demodicosis; Dry Eye Disease