Early findings in a randomised controlled trial on crosslinking protocols using isoosmolar and hypoosmolar riboflavin for the treatment of progressive keratoconus.

PURPOSE: To present baseline characteristics and to present the perioperative corneal thickness during corneal crosslinking (CXL) treatment for progressive keratoconus and to describe how the addition of sterile water (SW) efficaciously can maintain the corneal thickness. The treatment efficacy will be evaluated when the 1-year follow-up is complete. METHODS: A randomised clinical study using epithelium-off CXL with continuous UVA irradiation (9 mW/cm2) and two kinds of riboflavin solutions: (i) isoosmolar dextran-based riboflavin (n = 27) and (ii) hypoosmolar dextran-free riboflavin (n = 27). INCLUSION CRITERIA: progressive keratoconus with an increase in maximum keratometry value (Kmax) of 1.0 dioptre (12 months) or 0.5 dioptres (6 months). Corneae thinner than 400 µm were also included. OUTCOME PARAMETERS: Perioperative corneal thickness and the effect of adding SW. RESULTS: Seventy-four per cent of the patients in the isoosmolar group and 15% in the hypoosmolar group required the addition of SW, which effectively maintained a corneal thickness of 400 µm in all cases during CXL. The addition of SW was primarily needed during the irradiation procedure and not the preoperative soaking period. CONCLUSIONS: Especially during the CXL irradiation phase, isoosmolar riboflavin causes a significant dehydrating effect leading to corneal thinning during CXL. The customised addition of SW is efficacious in maintaining the corneal thickness during CXL and could increase the safety of the procedure.

Repeatability of Epithelium Thickness Measured by an AS-OCT in Different Grades of Keratoconus and Compared to AS-OCT/Placido Topography.

PURPOSE: To compare agreement of corneal epithelium thickness (ET) between AS-OCT system (RTVue, Optovue) and AS-OCT/Placido topographer (MS-39, CSO) in eyes with different stages of keratoconus (KC), and to assess the repeatability of RTVue AS-OCT. DESIGN: Prospective reliability analysis. METHODS: KC eyes were classified into forme fruste KC (FFKC), mild, moderate, and severe KC. Agreement was evaluated with Bland-Altman plots and 95% limits of agreement (LoA). The repeatability of RTVue was assessed via within-subject standard deviation (Sw), test-retest variability (TRT), coefficient of variation (CoV), and intraclass correlation coefficient (ICC). RESULTS: A total of 119 KC eyes were enrolled, with 21 being FFKC, 26 mild, 39 moderate, and 34 severe. The 95% LoA ranged between -5.9 and 4.8 µm for center epithelium thickness (CET), between -5.7 and 8.2 µm for thinnest epithelium thickness (TET). At 1-mm measuring points, the 95% LoA of superior, inferior, nasal, and temporal were -4.2 to 4.7 µm, -5.2 to 6.0 µm, -7.9 to 10.2 µm, and -11.2 to 6.0 µm. At 3-mm measuring points, the corresponding values were -2.8 to 9.3 µm, -2.0 to 13.0 µm, -4.6 to 9.6 µm, and -6.3 to 9.7 µm, indicating that the 2 instruments were not interchangeable without adjustment. Despite that the repeatability of RTVue measurements in KC patients were acceptable, repeatability decreased gradually with the peripheralization of the measurement points. CONCLUSIONS: The 2 OCT-based devices, RTVue and MS-39, do not provide interchangeable measurements of epithelium thickness in KC patients. Repeatability decreases in cases of more severe KC, emphasizing the importance of grading before clinical examination to avoid diagnostic errors.

Assessing progression limits in different grades of keratoconus from a novel perspective: precision of measurements of the corneal epithelium.

BACKGROUND: To assess repeatability and reproducibility of corneal epithelium thickness (ET) measured by a spectral-domain optical coherence tomographer (SD-OCT)/Placido topographer (MS-39, CSO, Florence, Italy) in keratoconus (KC) population at different stages, as well as to determine the progression limits for evaluating KC progression. METHODS: A total of 149 eyes were enrolled in this study, with 29 eyes in the forme fruste keratoconus (FFKC) group, 34 eyes in the mild KC group, 40 eyes in the moderate KC group, and 46 eyes in the severe KC group. Employing the within-subject standard deviation (Sw), test-retest variability (TRT), coefficient of variation (CoV), and intraclass correlation coefficient (ICC) to evaluate intraoperator repeatability and interoperator reproducibility. RESULTS: The repeatability and reproducibility of MS-39 in patients with KC were acceptable, according to ICC values ranging from 0.732 to 0.954. However, patients with more severe KC and progressive peripheralization of the measurement points had higher TRTs but a thinning trend. The current study tended to set the cut-off values of mild KC, moderate KC, and severe KC to 4.9 µm, 5.2 µm, and 7.4 µm for thinnest epithelium thickness (TET). When differences between follow-ups are higher than those values, progression of the disease is possible. As for center epithelium thickness (CET), cut-off values for mild KC, moderate KC, and severe KC should be 2.8 µm, 4.4 µm, and 5.3 µm. This might be useful in the follow-up and diagnosis of keratoconus. CONCLUSIONS: This study demonstrated that the precision of MS-39 was reduced in measuring more severe KC patients and more peripheral corneal points. In determining disease progression, values should be differentiated between disease-related real changes and measurement inaccuracies. Due to the large difference in ET measured by MS-39 between various stages of disease progression, it is necessary to accurately grade KC patients to avoid errors in KC clinical decision-making.