Dry Eye Clinical Trial
Official title:
Intense Pulsed Light and Meibomian Gland Expression (MGX) Versus MGX Alone in the Treatment of Dry Eye Disease Secondary to Meibomian Gland Dysfunction
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 expression of the meibomian glands. 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,
Outcome measures (tear break-up time, tear film osmolarity, meibomian gland assessment,
number of meibomian glands yielding liquid secretion in lower eyelid , 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 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 meibomian glands will be manually expressed from both
eyelids. 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.
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