Background: Keratoconus is a disease characterized by progressive distortion of the corneal anatomy, coupled with a decrease in vision. Assessing quality of life (QoL) in keratoconus is essential. So far, no instrument in the world has been designed to evaluate both visual function and emotional distress in this population. The purpose of the following study is to develop and validate the "Keratoconus End-Points Assessment Questionnaire" (KEPAQ) in a population of ectatic patients, the very first disease-specific scale to measure emotional latent traits in keratoconus. Methods: A last generation, Rasch analysis method was used for scale validation. First, a number of focus groups were carried out to create a pool of potential items. Then, a series of processes (such as "Content Validity Index") was carried out to develop a prior, 20question version of the KEPAQ. Then, a study including 150 keratoconus patients was performed, followed by a careful Rasch analysis to validate and optimize both sub-scales (Emotional Compromise, KEPAQ-E, and Functional Compromise, KEPAQ-F). Results: Initially, 86 items were considered as potential elements. After test optimization, 20 items were retained. A total of 150 patients with a confirmed diagnosis of keratoconus were included for the Rasch analysis. The mean age was 29.84 ± 9.96 years. In 150 patients, 12.6% had a history of keratoplasty, 46.0% had corneal rings, and 31.3% had crosslinking. For both sub-scales, misfitting items were removed until no misfitting was determined by repetitive Rasch runs. For the final version of the KEPAQ-E sub-scale, variance explained by the model was 62.4% with a dimensional scale. Person Separation Index and Person Number of Strata were 2.43 and 3.57, respectively. For the final version of the KEPAQ-F sub-scale, variance explained by the model was 61.3% with a unidimensional scale. Person Separation Index and Person Number of Strata were 3.19 and 4.59, respectively. Both sub-scales showed excellent Person Reliability. Conclusion: The KEPAQ is a robust scale, developed and validated through the latest theoretical models. It shows excellent psychometric properties, which render it extremely useful for both clinical and research use. To date, the KEPAQ is the only disease-specific scale worldwide to evaluate both functional and emotional compromise in keratoconus patients.

Background: Keratoconus is a disease characterized by progressive corneal distortion and quality of vision. So far, no study using disease-specific scales has evaluated whether different stages of the disease correlate with higher quality of life (QoL) compromise. Methods: A total of 114 patients with a confirmed diagnosis of Keratoconus were included in this retrospective study. All patients underwent a clinical and a Pentacam evaluation. They were also administered the "Keratoconus End-Points Assessment Questionnaire" (KEPAQ). Belin ABCD criteria were used for Keratoconus classification. "Better eye" was defined as the eye with the lowest maximum keratometry value. Spearman Rank Order Correlation was used to determine the correlation between the different Belin criteria and the KEPAQ scores in both subscales. Results: Mean age was 28.13 ± 11.57 years, with 39.47% of patients being male. Mean score for the KEPAQ-E was 2.33 ± 3.40 Logit, while for the KEPAQ-F, it was 1.85 ± 3.61 Logit. Criteria A (anterior elevation), B (posterior elevation) and D (visual acuity) in the worse eye correlated significantly with a greater decrease in QoL (p < 0.05 for all correlations). No correlation could be found regarding the better eye. Conclusion: A greater corneal distortion in the worse eye, as determined by Belin ABCD, is associated with a greater decrease in patient's QoL. Surgical improvement of the worse eye should probably be performed before surgery of the better eye, as it may provide a better response regarding the quality of life improvement.

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