Original articleBaseline Factors Predictive of Incident Penetrating Keratoplasty in Keratoconus
Section snippets
Methods
The CLEK Study protocol was approved by each clinic’s institutional review board, and the clinics obtained informed consent from each patient. The protocol has been described in detail elsewhere.18 Eligibility criteria included age 12 years or older, an irregular corneal surface in either eye, and the presence of biomicroscopic findings in at least one eye (Vogt striae, Fleischer ring, or corneal scarring characteristic of keratoconus). Exclusion criteria were bilateral corneal transplants or
Results
At baseline, 118 of the initially enrolled 1,209 patients had already undergone corneal surgery (116 penetrating keratoplasties and two epikeratoplasties) and were excluded from the analysis. Also excluded were 26 patients who dropped out of the study before completing any follow-up visits. Thus the analysis sample for this report consisted of 1,065 patients who had not undergone penetrating keratoplasty or epikeratoplasty and had completed at least one follow-up visit. Of these 1,065 patients,
Discussion
The CLEK Study is the first prospective cohort study to report the rate of PK in a large and geographically dispersed sample of patients diagnosed with keratoconus. Over eight years of follow-up, 12% of the 1,065 patients who entered the study without PK in either eye underwent PK in one or both eyes (9.3% in one eye; 2.5% in both eyes). The 82% completion rate of the close-out visit protects against biased loss to follow-up and biased ascertainment of PK. The rate of PK was similar at CLEK
Mae O. Gordon, PhD, Professor, Department of Ophthalmology and Visual Sciences and Division of Biostatistics at Washington University School of Medicine, is Director of Coordinating Centers for the Collaborative Longitudinal Evaluation of Keratoconus Study and the Ocular Hypertension Treatment Study. Dr Gordon research interests include design and implementation of clinical trials, development of outcome measures, and adherence to treatment regiments.
References (22)
- et al.
Keratoconus and related noninflammatory corneal thinning disorders
Surv Ophthalmol
(1984) Keratoconus
Surv Ophthalmol
(1998)- et al.
A 48-year clinical and epidemiologic study of keratoconus
Am J Ophthalmol
(1986) - et al.
Clinical management of keratoconusA multicenter analysis
Ophthalmology
(1990) - et al.
KeratoconusContact lens or keratoplasty?
Ophthalmology
(1988) - et al.
Prognostic factors for the progression of keratoconus
Ophthalmology
(1994) - et al.
Contact lens failure in keratoconus management
Ophthalmology
(1992) - et al.
KeratoconusEvaluation of recent trends in the surgical and nonsurgical correction of keratoconus
Ophthalmology
(1988) 1990 to 1992 report
Aust N Z J Ophthalmol
(1993)- et al.
Nineteen years of penetrating keratoplasty in the Hotel-Dieu Hospital in Paris
Cornea
(2001)
Indications for penetrating keratoplasty and associated procedures
Cornea
Cited by (112)
Personalized Model to Predict Keratoconus Progression From Demographic, Topographic, and Genetic Data
2022, American Journal of OphthalmologyKeratoconus: An updated review
2022, Contact Lens and Anterior EyeKeratoconus in India: Clinical presentation and demographic distribution based on big data analytics
2024, Indian Journal of Ophthalmology
Mae O. Gordon, PhD, Professor, Department of Ophthalmology and Visual Sciences and Division of Biostatistics at Washington University School of Medicine, is Director of Coordinating Centers for the Collaborative Longitudinal Evaluation of Keratoconus Study and the Ocular Hypertension Treatment Study. Dr Gordon research interests include design and implementation of clinical trials, development of outcome measures, and adherence to treatment regiments.
See accompanying Editorial on page 1044.