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Rigid Scleral Contact Lens Approved for Marketing

CCFDIE|Updated: 2023-08-03

     

Recently, the innovative product Rigid Scleral Contact Lens of Shanghai Aikangte Medical Technology Co., Ltd. is approved by China NMPA.

This product is a daily-wear and large-diameter rigid scleral contact lens (commonly known as "scleral lens"). The lens material is hexafocon A, colored in ice blue. This product is composed of four arc segments: optical zone, peripheral central clearance zone, limbus corneal zone and scleral landing zone. During clinical testing, parameter adjustments can be made to each arc segment to obtain a more ideal thickness of the microscopic fluid, improving the patient's visual quality while also protecting corneal tissue. This product innovatively adopts a double sagittal deep asymmetric design, which can better match the asymmetric sclera. The scleral landing area is designed with a reverse curved surface, providing patients with a more comfortable wearing experience.

This product is suitable for patients with refractive errors or for those who have +25.00D to -25.00D with corneal regular astigmatism less than 5.00D to correct irregular astigmatism. The marketing of this product will provide more options for clinical treatment.

The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.