Patient-Reported Outcomes in Keratoconus: A Save Sight Keratoconus Registry Study.

PURPOSE

The aim of this study was to evaluate the quality-of-life (QoL) status in keratoconus severity subgroups using the Keratoconus Outcomes Research Questionnaire (KORQ) and to determine the relationship between the QoL scores and the standard clinical variables.

METHODS

A cross-sectional study was conducted using prospective, web-based Save Sight Keratoconus Registry data. Rasch analysis was conducted on the KORQ data using the Andrich Rating Scale Model. Comparative analysis included Welch t test and 1-way ANOVA. Associations between visual acuity, corneal curvature, and minimum corneal thickness with KORQ scores were evaluated with Pearson correlation and multiple regression adjusted for age and sex.

RESULTS

The KORQ was completed by 542 patients with keratoconus (male, 67.7%; mean age, 31.6 years). Keratoconus severity, based on Kmax, was mild [<48 diopter (D)], moderate (48-55 D), and severe (>55 D) in 26.3%, 45.0%, and 28.7% of patients, respectively. Activity limitation (AL) and symptoms (SY) scales of the KORQ had robust psychometric properties including well-functioning response categories, unidimensionality, excellent measurement precision, and satisfactory fit statistics. In a group-wise analysis, the female patients had significantly lower AL and SY scores. Similarly, the severe keratoconus group had the worst AL and SY scores. Contact lens wearers had worse KORQ scores than the spectacles wearers. Overall, statistically significant but weak correlations between KORQ scores and visual acuity and corneal curvature (Kmax and K2) (Pearson r, 0.11-0.35) were observed. The correlations for SY were weaker than for AL scores.

CONCLUSIONS

Female sex, contact lens wear, reduced visual acuity, and higher disease severity were associated with worse AL and SY scores in keratoconus. Although the correlations between clinical and QoL scores were statistically significant, the low magnitudes suggested a complex relationship between clinical parameters and patient-reported outcomes.