Purpose. To describe the baseline findings in patients enrolled in the Coll
aborative Longitudinal Evaluation of Keratoconus (CLEK) Study.
METHODS. This is a longitudinal observational study of 1209 patients with k
eratoconus enrolled at 16 clinical centers. Its main outcome measures are c
orneal scarring, visual acuity, keratometry, and quality of life.
RESULTS. The CLEK Study patients had a mean age of 33.29 +/- 10.90 years wi
th moderate to severe disease, assessed by a keratometric-based criterion (
95.4% of patients had steep keratometric readings of at least 45 D) and rel
atively good visual acuity (77.9% had best corrected visual acuity of at le
ast 20/40 in both eyes). Sixty-five percent of the patients wore rigid gas-
permeable contact lens, and most of those (73%) reported that their lenses
were comfortable. Only 13.5% of patients reported a family history of kerat
oconus. None reported serious systemic diseases that had been previously re
ported to be associated with keratoconus. Many (53%) reported a history of
atopy. Fifty-three percent had corneal, scarring in one or both eyes.
CONCLUSIONS. Baseline findings suggest that keratoconus is not associated w
ith increased risk of connective tissue disease and that most patients in t
he CLEK Study sample represent mild to moderate keratoconus. Additional fol
low-up of at least 3 years will provide new information about the progressi
on of keratoconus, identify factors associated with progression, and assess
its impact on quality of life.