Indication for Use:
In EU: Evaporative Dry Eye Disease (DED), also known as dry eye syndrome or lipid tear deficiency, due to Meibomian Gland Dysfunction (MGD). This indication is intended for Fitzpatrick skin types I-V.
In US: 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.
The indications are only relevant where they were approved by the Regulatory Authorities.
Treatment with OptiLight 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; Uncontrolled infections or uncontrolled immunosuppressive diseases; Recent Ocular infections; 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.
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.
