New Medical Device

In overseas, there is a method of using scleral-supported special large hard contact lenses for improved visual acuity, which, however, is not appropriate in Asian patients and in patients with severe SJS/TEN with severe adhesion because of a large diameter (approximately 16 to 23 mm) of the lenses.

The Department of Ophthalmology of Kyoto Prefectural University of Medicine developed a uniquely designed hard contact lens (limbal-supported HCL) of 13 to 14 mm in diameter in collaboration with Sun Contact Lens Co., Ltd. and has been conducting clinical research in patients with corneal epithelial stem cell deficiency.

When patients put on this contact lens, lacrimal fluid enters between the lens and the cornea. This alleviates irregularities on the corneal surface and makes it possible to correct visual acuity. Furthermore, the lens prevents lacrimal fluid from being evaporated and alleviates clinical presentations associated with dry eye. Among 65 eyes in 52 patients studied in clinical research, not only significantly improved visual acuity but also improved quality of life related to visual acuity could be obtained in 53 eyes in 42 patients, who were affected by SJS.

An investigator-initiated clinical trial was conducted for the limbal-supported contact lens as a new medical device for patients with visual impairment due to SJS/TEN in 2014. (“Development of New Medical Devices for Overcoming Severe Multiform Exudative Erythema [Eye Disorder],” as a part of the Research Program for Overcoming Intractable Diseases by the MHLW [2013-2014])

History of scleral-supported special large hard contact lenses

June 2015: Regulatory application was made for approval.
February 2016: Regulatory approval was obtained.
October 2016: Prescription was started at the Department of Ophthalmology of Kyoto Prefectural University of Medicine.