Development and Initial Validation of the MCL-PRO-CAT: A computerized adaptive test designed to measure multifocal contact lens performance from the patient's perspective.

PURPOSE: To create a valid and reliable computer-adaptive testing (CAT) tool for assessing Multifocal Contact Lens (MCL) performance in presbyopic individuals, ensuring high precision. The self-administered tool will initially be accessible online in Spanish.

METHODS

Five steps were followed for the correct development of the instruments: item bank development, item refinement phase, item response theory calibration of the refined item bank, CAT simulations and design, and an initial validation study. A total of 1163 presbyopic patients were involved in the over-all study. Convergent validity was assessed by comparing results to the CLDQ-8 questionnaire, and repeatability assessment was performed two weeks after the initial completion.

RESULTS

The final item bank consisted of 108 items assessing various relevant domains for MCL performance evaluation. The calibration study showed a person separation index of 4.69 and a reliability of 0.96 along with a measurement precision of 0.27. The final CAT distinguished between 16 levels of MCL performance by presenting an average of 10.61  ± 1.00 items per patient, with an average completion time of 3:04 ± 1:24 min. Signs of convergent validity showed a correlation of 0.73 and repeatability was assessed showing an intraclass Correlation Coefficient of 0.881 with a 95% Confidence Interval 0,815-0,924, and Limits of Agreement of  ± 1.07.

CONCLUSION

The MCL-PRO-CAT is a groundbreaking tool for evaluating MCL performance in presbyopic individuals. With automated scoring and fewer items, it was feasible, valid, and precise, enhancing clinical practicality.