Effectiveness of Intense Pulsed Light for Improving Dry Eye Syndrome
Condition: Dry Eye Syndrome
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Meibomian Gland Dysfunction; Syndrome
Study type: Interventional

Summary: 
      The aim of the current study is to examine the contribution of intense pulsed light (IPL) for
      relieving signs and symptoms of dry eye due to meibomian gland dysfunction. The effect of IPL
      will be examined in a study designed as a randomized controlled trial. In the study arm,
      subjects will undergo 4 treatment sessions, consisting of IPL pulses immediately followed by
      meibomian gland expression (MGX). In the control arm, subjects will undergo the same
      treatments, except that the IPL pulses will be disabled. For each subject, the duration of
      the study will be 10 weeks, as explained in the detailed description.
    

Detailed description: 
      Outcome measures (tear break-up time,meibography, self-assessed symptoms and close up photos
      of the lid margins) will be measured at baseline. 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 intense pulsed light (IPL) administered in the malar region, from tragus to
      tragus including the nose, 2-3 mm below the lower eyelids. Immediately following the 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 IPL administration will be sham. A single follow-up will occur at 10 weeks after the
      baseline (or 4 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 10 weeks: 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 10 weeks after baseline).

      Statistically significant differences between the two arms will support the study hypothesis
      that IPL treatment itself provides relief to both signs and symptoms of dry eye disease.
    

Intervention name(s): IPL; Sham 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 10-15 IPL pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression.; Sham 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 of10-15 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 two Q-tips positioned on either side of the meibomian glands, or with a meibomian gland expressor forceps
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 IPL and meibomian gland expression. Subjects in the control arm will be treated with sham and meibomian gland expression.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Intense Pulsed Light; Meibomian Gland Dysfunction; Dry Eye Disease