Overview
EN ISO 11979-10:2018 (ISO 11979-10:2018) - "Ophthalmic implants - Intraocular lenses - Part 10" specifies clinical-investigation requirements for phakic intraocular lenses (IOLs) implanted in the anterior segment with the primary aim of modifying refractive power. The standard covers three optical categories of phakic IOLs:
- Phakic monofocal (PIOL)
- Phakic multifocal (PMIOL)
- Phakic toric (PTIOL)
Each category is further designated by intended implantation location (anterior or posterior chamber). EN ISO 11979-10:2018 focuses on clinical aspects not fully addressed in other ISO 11979 parts and updates prior editions to include multifocal and toric phakic designs.
Key Topics
- Scope and definitions related to phakic IOLs and ametropia correction in phakic eyes.
- Clinical investigation design: requirements and recommendations for planning clinical studies, including justification for new models and risk-based approaches for modifications of existing devices.
- Characteristics to evaluate: optical, mechanical and functional clinical endpoints appropriate for PIOL, PMIOL and PTIOL designs.
- Additional design-specific requirements: extra clinical considerations for phakic multifocal and phakic toric lenses (e.g., visual performance across distances and astigmatic correction).
- Safety and performance monitoring: duration of follow-up, adverse-event reporting, bilateral implantation considerations, surgical technique, and post-operative examinations.
- Supportive elements: statistical methods and sample-size guidance (Annex B) and recommended elements for clinical investigations (Annex A).
- Integration with other parts of ISO 11979: cross-references to requirements on vocabulary, optical/mechanical test methods, labelling, biocompatibility, shelf-life and transport stability (e.g., ISO 11979-1 to ISO 11979-8).
Applications
Who uses EN ISO 11979-10:2018 and why:
- Medical device manufacturers developing or modifying phakic IOLs - to design compliant clinical investigations and demonstrate safety/performance for regulatory submissions.
- Clinical researchers and ophthalmic surgeons - to align trial protocols, inclusion/exclusion criteria, follow-up schedules and adverse-event reporting with international best practice.
- Regulators and notified bodies - to assess clinical evidence for market approval and post-market surveillance.
- Contract research organizations (CROs) and statisticians - for study planning, sample-size calculations and outcome analysis.
Keywords useful for search: EN ISO 11979-10:2018, phakic intraocular lenses, clinical investigations, PIOL, PMIOL, PTIOL, ophthalmic implants, ISO 11979.
Related Standards
Key referenced parts of the ISO 11979 series include:
EN ISO 11979-10:2018 should be used alongside these parts to ensure comprehensive technical and clinical compliance.