1.3 Why does Standardization Matter?

Standardization makes results comparable. When studies use consistent testing conditions, measurement methods, and reporting criteria, differences in outcomes are more likely to reflect the treatment or technology being evaluated rather than differences in how vision was measured. This is particularly important when comparing IOLs across studies, centers, or populations, and when combining results in systematic reviews or meta-analyses.

IOLResearch has been developed with established clinical standards and recommendations in mind, but IOLResearch is not itself a standard. Researchers may use IOLResearch or any other validated test or tool that follows the same standardized guidelines.

For IOL clinical studies, these principles are described in published recommendations for collecting and reporting outcomes [1], which encourage standardized visual acuity measurement and reporting to facilitate comparison between studies [2]. They are also addressed by ISO 11979-7:2024, the current international standard for clinical investigations of IOLs, which includes requirements for visual acuity and depth-of-focus testing, and ANSI Z80.35-2018 for extended-depth-of-focus IOLs, which covers clinical investigations and test methods and explicitly allows alternative validated test methods [3,4].

Key references

Fernández J, Ribeiro FJ, Rodríguez-Vallejo M, et al. Standard for collecting and reporting outcomes of IOL-based refractive surgery: update for enhanced monofocal, EDOF, and multifocal IOLs. J Cataract Refract Surg. 2022;48:1235–1241.
Fernández J, Rocha-De-Lossada C, Rodríguez-Vallejo M. Recommendations for Writing Clinical Research Manuscripts: From Monofocal to Multifocal Intraocular Lenses. Int J Environ Res Public Health. 2022;19:17036.
ISO 11979-7:2024. Ophthalmic implants — Intraocular lenses — Part 7: Clinical investigations of intraocular lenses for the correction of aphakia.
ANSI Z80.35-2018 (R2023). Ophthalmics — Extended Depth of Focus Intraocular Lenses