Overview
SIST EN ISO 11979-10:2018, titled Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes, is an international standard defining clinical investigation requirements for phakic intraocular lenses (PIOLs). These lenses are implanted in the anterior segment of the eye and are primarily indicated for the modification of refractive power in phakic (natural lens present) eyes. This standard applies to three optical design categories of phakic IOLs:
- Phakic monofocal intraocular lenses (PIOL)
- Phakic multifocal intraocular lenses (PMIOL)
- Phakic toric intraocular lenses (PTIOL)
These categories are specified for implantation in either the anterior or posterior chamber of the anterior segment. ISO 11979-10:2018 outlines essential safety, performance, and investigational design requirements to ensure the effectiveness and biocompatibility of phakic IOLs for ametropia correction.
Key Topics
- Types of Phakic IOLs: The standard covers clinical investigations for monofocal, multifocal, and toric phakic IOLs, each with unique optical designs targeting specific refractive needs, such as myopia, hyperopia, astigmatism, and presbyopia correction.
- Clinical Investigation Design: Both controlled and non-controlled clinical investigations are addressed. Key requirements include assessment duration (minimum three years), primary safety endpoints (e.g., endothelial cell density), and inclusion/exclusion criteria for participants.
- Safety and Performance Endpoints: Endothelial cell density is highlighted as the primary safety parameter for all PIOL investigations. For PTIOLs, rotational stability is crucial, while for PMIOLs, evaluation of multiple focal vision (far, intermediate, near) is required.
- Subject Selection and Risk Management: The document specifies strict inclusion/exclusion criteria-including age, refractive stability, endothelial cell density, medical history, and ocular health-to minimize risks and ensure reliable data collection.
- Manufacturer's Information: Requirements are set for labelling, contraindications, and reporting of clinical investigation outcomes, including detailed data on postoperative cell loss and performance results.
Applications
The practical applications of ISO 11979-10:2018 in ophthalmology and medical device industries include:
- Development and Regulatory Approval: Guiding manufacturers in designing and conducting robust clinical investigations for new phakic IOL products, facilitating regulatory approval and market introduction.
- Clinical Safety and Efficacy Assessment: Establishing standardized methods for evaluating postoperative outcomes such as visual acuity, refractive stability, and device-related adverse events, ensuring patient safety and optimal surgical results.
- Risk Analysis and Continuous Improvement: Integrating risk management and iterative improvements in phakic IOL design, supporting innovations that enhance patient outcomes and expand the indications for refractive correction.
- Informed Patient Selection: Assisting surgeons and healthcare providers in selecting appropriate candidates for phakic IOL implantation based on standardized clinical criteria to maximize treatment success and minimize complications.
Related Standards
ISO 11979-10:2018 references and complements several related standards in the field of ophthalmic implants and clinical investigations:
- ISO 11979-1: Ophthalmic implants - Intraocular lenses - Vocabulary
- ISO 11979-2: Optical properties and test methods for intraocular lenses
- ISO 11979-3: Mechanical properties and test methods
- ISO 11979-4: Labelling and information for intraocular lenses
- ISO 11979-5: Biocompatibility requirements
- ISO 11979-6: Shelf-life and transport stability testing
- ISO 11979-7: Clinical investigations of lenses for correction of aphakia
- ISO 11979-8: Fundamental requirements
- ISO 14971: Risk management for medical devices
- ISO 14155: Clinical investigation of medical devices for human subjects - Good clinical practice
By adhering to SIST EN ISO 11979-10:2018, manufacturers and clinicians can ensure that phakic intraocular lenses for ametropia correction meet internationally recognized standards for safety, quality, and clinical efficacy. This supports better patient outcomes and global harmonization of ophthalmic device regulations.