Biomedical subjects

CLEK Study Group

Publications and source records attributed to CLEK Study Group.

3 recordsLinked to original sources

PubMed2006

Estimation of the incidence and factors predictive of corneal scarring in the Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study.

PURPOSE: The multicenter Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study is a prospective, observational study of 1209 keratoconus patients. We report methods to define incident corneal scarring and baseline factors predictive of incident corneal scarring in nonsurgical eyes of CLEK Study keratoconus patients through their fifth year of follow-up. METHODS: Of the 1,209 patients, 878 patients with at least one unscarred cornea at baseline were included in this study. The cumulative 5-year incidence of scarring is defined as the proportion of patients who developed central corneal opacification as detected by a clinician examining the patient with a slit-lamp biomicroscope and by masked readings of corneal photographs at the CLEK Photography Reading Center. Logistic regression analysis was used to test for relationships between baseline factors and incident corneal scarring. Baseline factors analyzed included age, sex, race, atopic disease, contact lens wear, family history of keratoconus, corneal curvature, and central corneal fluorescein staining, among others. RESULTS: The 5-year incidence of corneal scarring was 13.7% (120 of 878) overall, 16.7% (102 of 609) for contact lens-wearing eyes, and 38.0% (46 of 121) for contact lens-wearing eyes with corneal curvature greater than 52 D. Baseline factors predictive of incident scarring included corneal curvature greater than 52 D (odds ratio [OR] = 4.79; 95% confidence interval [CI], 3.08, 7.45; P < 0.001), contact lens wear (OR = 2.50; 95% CI, 1.40, 4.76; P = 0.003), marked corneal staining (OR = 2.38; 95% CI, 1.49, 3.76; P = 0.0002), and age less than 20 years (OR = 6.34; 95% CI, 2.57, 15.00; P < 0.0001). CONCLUSIONS: Multivariate analyses of 5-year prospective data from the CLEK Study cohort showed that baseline corneal curvature, contact lens wear, corneal staining, and younger age were predictive of the development of corneal scarring. The 5-year incidence of scarring is 13.7% for the overall sample and 38.0% for those eyes with corneal curvature greater than 52 D that wore contact lenses. Contact lens wear increased the risk of incident scarring more than 2-fold. These findings suggest a causal contribution of contact lens wear to corneal scarring in keratoconus and imply that corneal scarring might be reduced by modifying the contact lens fit.

Adult↗

PubMed2006

Longitudinal changes in corneal curvature in keratoconus.

PURPOSE: This study was designed to identify factors that predict longitudinal increases in corneal curvature as measured by the First Definite Apical Clearance Lens (FDACL) and flatter keratometric reading (Flat K) in keratoconus. METHODS: The Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study is a long-te rm evaluation of the natural history of keratoconus involving 1209 patients. This report uses 8 years of follow-up data from 1032 patients who had penetrating keratoplasty in neither eye at baseline and who provided enough data to compute the slope of the change with time in the FDACL or the Flat K. Outcome measures included the aforementioned slopes and whether the FDACL or the Flat K increased by 3.00 or more diopters (D) in at least 1 eye. RESULTS: At CLEK Study entry, patients were aged 38.9 +/- 10.8 years. Overall, 44.3% of them were women, and 69.3% of them were white. The slope of the change in FDACL (0.18 +/- 0.60 D/y) and Flat K (0.20 +/- 0.80 D) during 8 years translates into expected 8-year increases of 1.44 D in FDACL and 1.60 D in Flat K. Increases of > or = 3.00 D in either eye had an 8-year incidence of 24.8% for FDACL and 24.1% for Flat K. Independent predictors of increased FDACL included younger age, poorer baseline high-contrast manifest refraction visual acuity, and non-white race. Younger age and poorer high-contrast manifest refraction visual acuity were independent predictors of a >3.00-D increase for both FDACL and Flat K. CONCLUSION: CLEK patients exhibited a slow but clear increase in corneal curvature. Younger age and poorer high-contrast manifest refraction visual acuity at baseline predicted the rate of change in corneal curvature.

Adult↗

PubMed2006

A new method for grading the severity of keratoconus: the Keratoconus Severity Score (KSS).

PURPOSE: To define a new method for grading severity of keratoconus, the Keratoconus Severity Score (KSS). METHODS: A rationale for grading keratoconus severity was developed using common clinical markers plus 2 corneal topographic indices, creating a 0 to 5 severity score. An initial test set of 1012 eyes, including normal eyes, eyes with abnormal corneal and topographic findings but not keratoconus, and eyes with keratoconus having a wide range of severity, was used to determine cutpoints for the KSS. Validation set 1, comprising data from 128 eyes, was assigned a KSS and compared with a clinician's ranking of severity termed the "gold standard" to determine if the scale fairly represented how a clinician would grade disease severity. kappa statistics, sensitivity, and specificity were calculated. A program was developed to automate the determination of the score. This was tested against a manual assignment of KSS in 2121 (validation set 2) eyes from the Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study, as well as normal eyes and abnormal eyes without keratoconus. Ten percent of eyes underwent repeat manual assignment of KSS to determine the variability of manual assignment of a score. RESULTS: From initial assessments, the KSS used 2 corneal topography indices: average corneal power and root mean square (RMS) error for higher-order Zernike terms derived from the first corneal surface wavefront. Clinical signs including Vogt striae, Fleischer rings, and corneal scarring were also included. Last, a manual interpretation of the map pattern was included. Validation set 1 yielded a kappa statistic of 0.904, with sensitivities ranging from 0.64 to 1.00 and specificities ranging from 0.93 to 0.98. The sensitivity and specificity for determining nonkeratoconus from keratoconus were both 1.00. Validation set 2 showed kappa statistics of 0.94 and 0.95 for right and left eyes, respectively. Test-retest analysis yielded kappa statistics of 0.84 and 0.83 for right and left eyes, respectively. CONCLUSION: A simple and reliable grading system for keratoconus was developed that can be largely automated. Such a grading scheme could be useful in genetic studies for a complex trait such as keratoconus requiring a quantitative measure of disease presence and severity.

Cornea↗