Abstract
Purpose
To evaluate in a large sample of patients from 10 different European centers the results of cataract surgery, characterizing the relationship between patient-reported outcomes (PROMs) and clinician-reported outcome measures (CROMs).
Methods
Prospective non-interventional multicenter observational descriptive study analyzing the clinical outcomes of a total of 3799 cases undergoing cataract surgery (mean age: 72.7 years). In all cases, the cataract surgery standard developed by the International Consortium for Health Outcomes Measurements (ICHOM) was used to register the clinical data. Three-month postoperative visual acuity and refraction data were considered CROMs, whereas Rasch-calibrated item 2 (RCCQ2) and total Catquest-9SF score (CQ) were considered PROMs.
Results
Postoperative corrected distance visual acuity (CDVA) was 0.3 logMAR or better in 88.7% (2505/2823) of eyes. Mean differences between preoperative and postoperative RCCQ2 and CQ scores were −3.09 and −2.39, respectively. Visual function improvement with surgery was reported by 91.5% (2163/2364) of patients. Statistically significant, although weak, correlations of postoperative CDVA with postoperative refraction, PROMs, and complications were found (0.133 ≤ r ≤0.289, p < 0.001). A predictive model (R2: 0.254) of postoperative CDVA considering 10 variables was obtained, including preoperative CDVA, different ocular comorbidities, age, gender and intraoperative complications. Likewise, another predictive model (R2: 0.148) of postoperative CQ considering a total of 14 variables was obtained, including additionally preoperative CQ, target refraction and previous surgeries.
Conclusions
Cataract surgery provides an improved functional vision in most of patients although this improvement can be limited by ocular comorbidities and complications. The relationship between PROMs and CROMs is multifactorial and complex.
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Acknowledgements
The authors gratefully acknowledge the participation in this study of Quodem by performing the statistical analysis of the current study. European CAT-Community Study Group, Annemijn Knitel, Roberto Bergado-Mijangos, Daniel Coello-Ojeda, Itziar Ozaeta, Beatriz Macias-Murelaga, Jesús Garrido Fierro, Cristian E Dalmasso, Pío Jesús Garcia-Gómez, Mari Himanka, Javier Martínez, Meilin Chang-Sotomayor, Anna Camós-Carreras, Felipe Spencer, Noelia Sabater-Cruz, Carlo Scardellato, Carmen Dell’Aquila, Giulia Pian
Funding
This study has been sponsored by a grant from Johnson & Johnson Vision. The author David P Piñero has been supported by the Ministry of Economy, Industry and Competitiveness of Spain within the program Ramón y Cajal, RYC-2016-20471. No additional funding was received for the performance of this study. European CAT-Community Study Group, Annemijn Knitel, Roberto Bergado-Mijangos, Daniel Coello-Ojeda, Itziar Ozaeta, Beatriz Macias-Murelaga, Jesús Garrido Fierro, Cristian E Dalmasso, Pío Jesús Garcia-Gómez, Mari Himanka, Javier Martínez, Meilin Chang-Sotomayor, Anna Camós-Carreras, Felipe Spencer, Noelia Sabater-Cruz, Carlo Scardellato, Carmen Dell’Aquila, Giulia Pian
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the ethics committees of the centers involved in the study and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
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Zijlmans, B.L., van Zijderveld, R., Manzulli, M. et al. Global multi-site, prospective analysis of cataract surgery outcomes following ICHOM standards: the European CAT-Community. Graefes Arch Clin Exp Ophthalmol 259, 1897–1905 (2021). https://doi.org/10.1007/s00417-021-05181-5
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DOI: https://doi.org/10.1007/s00417-021-05181-5