What is an Intraocular Lens?
Intraocular lenses (IOLs) are surgically-implanted medical devices which are most often used to treat cataracts, nearsightedness, and/or astigmatism. IOLs incorporate a variety of lens geometries and materials for the purpose of optimizing vision correction. Some of the materials used include PMMA, acrylic, and silicone based polymers. Next generation IOLs seek to enhance overall vision quality by addressing multiple vision problems in one device or by enhancing devices for easier and safer surgeries. These new devices incorporate novel polymer materials which require analytical investigations, such as those listed under ISO 11979-5, to ensure safe implantation into humans.
Intraocular Lens Analytical Services at EKG Labs
EKG Labs provides analytical services to support companies developing IOLs according to the biocompatibility guidances set forth under ISO 11979-5. Our team has experience working with the various polymeric materials used in IOLs and preparing relevant data for regulatory submissions. Because of this, EKG Labs is an ideal analytical partner for companies wishing to assess the biocompatibility of intraocular devices.
ISO 11979-5 Guidance and Biocompatibility Testing at EKG Labs
EKG Labs uses the following series of tests to evaluate the physicochemical properties of IOLs that are relevant to biocompatibility:
- Exhaustive Extraction: EKG Labs performs exhaustive extraction on IOL materials to detect and quantify additives and other potential leachables under extreme conditions, typically on multiple lots using multiple solvents. The extracts then undergo analysis for volatiles, semi-volatiles, and non-volatiles using techniques such as GC/MS and LC/MS.
- Leachables: EKG Labs also performs leachables testing on ocular implants to detect and quantify extractable additives and other potential leachables under physiological conditions, typically on multiple lots using multiple solvents. The extracts then undergo analysis for volatiles, semi-volatiles, and non-volatiles using techniques such as UV/Vis, GC/MS, and LC/MS.
- Hydrolytic Stability: EKG Labs can additionally perform hydrolytic stability testing on ocular implant samples to determine the stability of the IOL materials in an aqueous environment. This is done through the detection and quantification of possible degradation products from hydrolysis detected through changes in physical appearance, optical properties, and chromatographic characteristics. The hydrolytic stability is typically performed in duplicate, on multiple lots, and using an aqueous medium. The extracts then undergo analysis for volatiles, semi-volatiles, and non-volatiles using techniques such as UV/Vis, GC/MS, and LC/MS. The extracted IOL samples also undergo analysis for spectral transmission using dioptric power and microscopy.
- Photostability: EKG Labs performs photostability testing on ocular implant samples, typically in physiological saline, to determine the photostability of IOL materials irradiated in the wavelength range of 300 nm to 400 nm. After exposure, the medium is analyzed for volatiles, semi-volatiles, and non-volatiles using techniques such as UV/Vis, GC/MS, and LC/MS.
- Insoluble Inorganics: EKG Labs analyzes the intraocular lens material for residual insoluble inorganics using ICP-MS. Typically, this includes two analyses: one on the entire intraocular lens and one from a wash from the surface of the lens.
Additional information regarding how we can support intraocular lens or ISO 11979-5 guidance testing can be found below: