Dry Eye Syndromes Clinical Trial
Official title:
Feasibility of Intense Pulsed Light (IPL) for Reducing Dry Eye Symptoms Caused by Meibomian Gland Dysfunction (MGD)
The purpose of this study is to evaluate if, in patients with meibomian gland dysfunction (MGD), treatment with the Lumenis M22 Intense Pulsed Light (IPL) system causes a reduction in dry eye symptoms post-treatment, compared to pre-treatment.
The IPL module has FDA clearance (K142860) for a wide range of indications, including benign
cavernous hemangiomas, benign venous malformations, telangiectasia, port-wine stains,
pigmented lesions and erythema of rosacea. As shown by a retrospective study, in over 85% of
the cases, using IPL in subjects with ocular rosacea also alleviated the symptoms of DED
caused by MGD. No serious adverse events were recorded, suggesting that IPL therapy
administered close to the ocular orbits is safe (provided that the eyes are shielded).
However, the above mentioned study was retrospective. Therefore, additional evidence is
needed in order to substantiate the hypothesis that alleviation of MGD symptom was
facilitated by IPL treatments.
The aim of the current study is to assess the safety and efficacy of IPL treatment for
reducing the symptoms of dry eye disease (DED) in subjects with MGD. The study hypothesis is
that in a study population of subjects diagnosed with moderate to severe MGD, 4 sessions of
IPL therapy with the M22 system, followed by expression of the MGs, will cause a significant
increase in tear break-up time post-treatment, compared to pre-treatment.
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