Overview
ISO 11979-10:2018 - "Ophthalmic implants - Intraocular lenses - Part 10" defines clinical-investigation requirements for phakic intraocular lenses (phakic IOLs) implanted in the anterior segment to correct refractive errors (ametropia) while preserving the natural crystalline lens. The standard covers three optical categories: phakic monofocal (PIOL), phakic multifocal (PMIOL) and phakic toric (PTIOL), each of which can be intended for anterior- or posterior-chamber implantation. It provides specific clinical requirements that complement other parts of the ISO 11979 series.
Key topics and technical requirements
- Scope and device categories: Defines PIOL, PMIOL and PTIOL categories and their chamber designations.
- Clinical design guidance: Specifies when to use non-controlled versus controlled clinical investigations:
- Non-controlled investigations for PIOLs and higher-cylinder PTIOLs.
- Controlled investigations for PMIOLs and low-cylinder PTIOLs (≤ 1.5 D).
- Primary safety endpoint: Endothelial cell density is identified as the principal safety measure for phakic IOL studies.
- PTIOL-specific requirement: Rotational stability must be demonstrated; objective performance criteria are given (absolute rotation < 10° in 90% of cases and < 20° in 95% of cases).
- PMIOL-specific requirement: Clinical assessment must evaluate visual performance at distance, near and any intended intermediate focal distances.
- Risk management and GCP: Risk analysis per ISO 14971 and clinical investigations conducted in accordance with ISO 14155.
- Cross-references: Optical, mechanical, biocompatibility, shelf-life and fundamental requirements are covered by other parts of ISO 11979 and are to be applied as relevant (ISO 11979-1 through -8).
- Additional content: Includes enrolment, inclusion/exclusion criteria, bilateral implantation, surgical technique, adverse-event reporting, and manufacturer information requirements; informative annexes address trial elements and statistical/sample-size considerations.
Practical applications and who uses this standard
- Manufacturers of phakic IOLs: design clinical investigations, prepare regulatory submissions, and justify modifications to existing models.
- Clinical investigators and ophthalmic surgeons: plan and conduct trials that meet international clinical and safety endpoints.
- Regulatory authorities and notified bodies: assess conformity, review clinical evidence for market authorization.
- Quality, regulatory and R&D teams: integrate risk management, GCP and device-specific testing into product development.
- Ethics committees and clinical trial sponsors: ensure study designs align with ISO/clinical requirements.
Related standards
- ISO 11979 series (Parts 1–8) - vocabulary, optical/mechanical tests, biocompatibility, shelf-life, labelling, fundamental requirements
- ISO 14155 - Clinical investigation of medical devices - Good clinical practice
- ISO 14971 - Risk management for medical devices
Keywords: ISO 11979-10:2018, phakic intraocular lenses, phakic IOL, PIOL, PMIOL, PTIOL, clinical investigations, endothelial cell density, rotational stability, ophthalmic implants.