Overview
ISO 11979-7:2024 - "Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia" specifies the particular requirements for clinical investigations of intraocular lenses (IOLs) implanted to correct aphakia. This fifth edition updates clinical testing guidance, clarifies lens-type definitions (including non‑accommodative Simultaneous Vision IOLs) and aligns clinical methodologies across lens subtypes. It is intended for new IOL models and for modifications of existing models where risk analysis indicates clinical data are needed.
Key topics and requirements
- Scope and purpose: Defines clinical investigation requirements specifically for IOLs used to correct aphakia.
- Lens categories: Monofocal IOLs, toric IOLs (TIOL), Simultaneous Vision IOLs (SVIOL) with subtypes MIOL (multifocal), EDF (extended depth of focus) and FVR (full visual range), and accommodating IOLs (AIOL). Also distinguishes by anatomic placement: posterior chamber vs anterior chamber.
- Design of clinical investigations: Comparative assessment of adverse event rates and visual acuities, with additional, lens‑type specific requirements (e.g., near/intermediate vision metrics for MIOL/EDF/FVR; toric rotational stability and refractive outcomes for TIOL).
- Risk and ethics: Requires implementation of risk analysis per ISO 14971 and application of clinical good practice per ISO 14155.
- Study conduct elements: Enrollment criteria, inclusion/exclusion rules, bilateral implantation guidance, surgical technique, follow‑up duration, adverse event reporting, and subject examination/treatment.
- Supporting material: Normative and informative annexes covering general clinical elements, additional elements for specific lens types, post‑operative adverse event evaluation, clinical tests, and statistical methods and sample size calculations (Annex G).
Applications and users
This standard is essential for:
- IOL manufacturers - designing premarket and post‑market clinical trials, preparing regulatory submissions, and guiding device modifications.
- Clinical investigators and ophthalmic surgeons - planning study protocols, defining endpoints (UDVA, UIVA, UNVA, CDVA, etc.), and performing study procedures.
- Regulatory authorities and notified bodies - evaluating clinical evidence for safety and performance.
- Clinical research organizations (CROs) and ethics committees - ensuring compliance with ISO 14155 and ISO 14971 during human subject research.
Practical uses include trial protocol development, selection of appropriate clinical endpoints for specific IOL types (e.g., intermediate vision for EDF), adverse event monitoring frameworks, and statistical planning.
Related standards
- ISO 11979-1 - Vocabulary for intraocular lenses
- ISO 11979-2 - Optical evaluation (informative for deciding clinical characteristics)
- ISO 11979-10 - Clinical investigations for phakic IOLs
- ISO 14155 - Good clinical practice for medical device trials
- ISO 14971 - Risk management for medical devices
Keywords: ISO 11979-7:2024, intraocular lenses, IOL clinical investigations, aphakia, toric IOL, SVIOL, MIOL, EDF, FVR, accommodating IOL, ISO 14155, ISO 14971.
Open preview (PDF)Ophthalmic implants — Intraocular lenses — Part 7: Clinical investigations of intraocular lenses for the correction of aphakia