The Children's Overnight Orthokeratology Investigation (COOKI) pilot study.

PURPOSE Innovations in contact lens materials and designs allow patients to wear contact lenses during sleep to flatten the cornea and temporarily to reduce myopic refractive error and improve unaided visual acuity. We conducted the Children's Overnight Orthokeratology Investigation (COOKI) pilot study, a case series, to describe the refractive error and visual changes, as well as the slitlamp observations associated with overnight orthokeratology in children, over a period of 6 months. METHODS Twenty-nine 8- to 11-year-old children with myopia between -0.75 and -5.00 D and <-1.50 D corneal toricity were fitted with corneal refractive therapy contact lenses (Paragon Vision Sciences, Mesa, AZ). They were examined within 1 hour of awakening and about 6 hours later at 1 day, 1 week, 2 weeks, 1 month, 3 months, and 6 months after the first night of contact lens wear. At each visit, the logarithm of the minimum angle of resolution (logMAR) visual acuity, manifest refraction, slitlamp examination, and corneal topography were performed. RESULTS Twenty-three subjects completed the 6-month study. Three subjects decided not to wear contact lenses, two did not achieve acceptable fits, and one moved from the area. At the 6-month afternoon visit, the mean +/- SD uncorrected high-contrast visual acuity was +0.08 +/- 0.15 logMAR (Snellen equivalent, 20/24), and the mean +/- SD spherical equivalent refraction was -0.16 +/- 0.66 D. The corneas of three-fifths of the subjects showed mild staining at the morning visit, and one-third of the patients showed mild corneal staining at the afternoon visit. The most common type of stain was central punctate staining. No subjects experienced lasting adverse visual effects from cornea-reshaping contact lens wear during the study period. CONCLUSIONS Overnight cornea-reshaping contact lenses are efficacious for young myopic patients, and no children experienced a serious adverse event during the study.