What Is an Intraocular Lens?

IOL refers to a special lens made of synthetic materials. Its components include silicone, polymethyl methacrylate, and hydrogel. The shape and function of the intraocular lens is similar to the lens of the human eye, and has the characteristics of light weight, high optical performance, non-antigenicity, inflammatory, carcinogenicity and biodegradability. After cataract surgery, the cloudy lens is removed, and the artificial lens is implanted in the eye to replace the original lens, so that external objects can be focused on the retina, and the surrounding scenes can be seen clearly.

Polymethylmethacrylate, or PMMA for short, was the first material used to make artificial lenses. After long-term clinical verification, PMMA is an ideal intraocular lens material.

PMMA has stable performance and high resistance to aging and environmental changes: acid, alkali, salt and organic solvents. But it is not heat-resistant. Below 100 ° C, PMMA is solid. When it exceeds 100 ° C, PMMA will become gelatinous and can be injection molded. PMMA is lightweight, not easily broken, and has a molecular weight of 250-300KD.

As an ideal intraocular lens material, PMMA also has certain disadvantages. The first is that it cannot be sterilized by heating, which will cause serious deformation; the second is that it has limited elasticity and cannot manufacture a foldable intraocular lens suitable for small incisions; it has limited tolerance to YAG lasers, and the monomers released after laser treatment have biological

For more than 50 years, the materials for making intraocular lens rhenium have developed greatly.

Pre-marketing clinical trials of IOLs in China should meet regulatory requirements. During the entire clinical trial of medical devices, including program design, implementation, inspection, verification, inspection, data collection, recording, analysis, summary, and reporting, etc., all shall follow the "Good Medical Device Clinical Trial Quality Management Specifications" and ensure clinical trial The process is standardized, and the results are authentic, scientific, reliable and traceable.