The design of the multicenter study of light reduction in retinopathy of prematurity (LIGHT-ROP)

Background: The LIGHT-ROP Study was a multicenter, prospective, randomized, controlled, clinical trial designed to determine if a reduction in ambient light exposure to premature infants' eyes would reduce the incidence of re tinopathy of prematurity (ROP). Previous clinical reports were contradictor y and had one or more methodological flaws. Methods: The LIGHT-ROP trial was designed in rigorous fashion to include ra ndomization to treatment or control groups, masking of examiners, an adequa te sample size of high-risk infants, a universal ROP classification system, a reliable and reproducible ophthalmologic examination protocol, a control led method of light reduction, and monitoring of light levels in the nurser y. The multicenter trial was conducted at three centers in Buffalo, Dallas, and San Antonio, with a separate coordinating center in Houston. The trial also utilized a-separate data and safety monitoring committee. Conclusion: The design of the LIGHT-ROP study represents the most rigorous and largest clinical trial to date. It has demonstrated that light reductio n does not reduce the incidence of confirmed ROP in high risk infants.