A new long-term study aims to determine whether orthokeratology with specially designed gas permeable (GP) contact lenses can safely and effectively control the progression of nearsightedness in children.
The clinical study, called the Stabilizing Myopia by Accelerating Reshaping Technique (SMART) study, will compare the progression of myopia among 267 children ages 8 to 14 that have been enrolled in the study. The research is taking place at 10 clinical research sites throughout the United States.
A total of 162 of children enrolled in the study have been successfully fit with the ortho-k contacts and will wear the GP lenses on an overnight basis throughout the five-year study period. The overnight ortho-k lenses enable the subjects to see clearly throughout the day without glasses or contact lenses.
A control group of 105 children in the study will wear silicone hydrogel contact lenses on a daily wear basis throughout the study, replacing the lenses monthly.
At yearly intervals, the children wearing the ortho-k lenses will return the gas permeable contacts to one of the study’s investigators and will be given soft contact lenses to wear temporarily. While wearing the soft lenses, the subjects’ eyes will be examined every three days until their myopia has stabilized.
The investigator will then compare this amount of myopia with how nearsighted the child was at the beginning of the study to determine the net effect of the ortho-k lenses on slowing the progression of nearsightedness. After this comparison is made, the participant will again wear the ortho-k lenses for another one-year period.
The researchers say the five-year SMART study will offer more information about the safety and effectiveness of overnight orthokeratology than previous ortho-k studies, which typically have evaluated subjects over a period of no more than two years and often for six months or less.
You can follow the progress of the research and get the latest updates by visiting the SMART Clinical Trial page on Facebook.
