Toyos et al. (2022) Intense pulsed light improves signs and symptoms of dry eye disease due to meibomian gland dysfunction: A randomized controlled study
The US FDA approval for Lumenis IPL with OPT™ for management of DED was based on this recent clinical study.
In this perspective, multi-center, double-blinded, randomized controlled study, Lumenis IPL with OPT™ combined with MGX significantly improved signs of DED due to MGD in patients with moderate to severe symptoms.
Indication for Use:
Improvement of signs of Dry Eye Disease (DED) due to Meibomian Gland Dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye, in patients 22 years of age and older with moderate to severe signs and symptoms of DED due to MGD and with Fitzpatrick skin types I-IV. IPL is to be applied only to skin on the malar region of the face, from tragus to tragus including the nose (eyes should be fully covered by protective eyewear). IPL is intended to be applied as an adjunct to other modalities, such as meibomian gland expression, artificial tear lubricants and warm compresses
Treatment with Lumenis IPL with OPT™ is contraindicated for patients with the following conditions in the treatment area:
Ocular surgery or eyelid surgery or Neuro-paralysis within 6 months prior to the first treatment; Uncontrolled eye disorders affecting the ocular surface; Pre-cancerous lesions, skin cancer or pigmented lesions in the planned treatment area; Uncontrolled infections or uncontrolled immunosuppressive diseases; Recent Ocular infections; Prior history of cold sores or rashes in the perioral area, including: Herpes simplex 1 & 2, Systemic Lupus erythematosus and porphyria; Use of photosensitive medication and/or herbs that may cause sensitivity within 3 months prior to the first IPL session; Recent radiation therapy to the head or neck or planned radiation therapy; Recent treatment with chemotherapeutic agent or planned chemotherapy; History of migraines, seizures or epilepsy.
Patients eyes must be completely occluded during the treatment. Please refer to the operator manual for a complete list of intended use, contraindications and risks.
Please consult your physician as to whether this procedure is suitable for you.
The following possible side effects can occur following IPL treatments:
Pain/discomfort, damage to natural skin texture, change of pigmentation, scarring, excessive edema, fragile skin, bruising, burns, pruritus and xerosis. Please refer to the user manual or ask your doctor for a complete list of intended use, contraindications and risks
- Lumenis has an interest in the study device (Lumenis IPL with OPT™)
- All uses of the Lumenis IPL with OPT™ described in this paper were approved by the FDA, except the following:
– The study concluded that both signs and symptoms of DED were improved by the use of IPL, whereas FDA cleared only improvement of signs.
- Dr. Toyos was a consultant of Lumenis
- Lumenis sponsored the study
- The publication doesn’t discuss any unapproved uses of the device.
PB-00043680 Rev A