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 retinopathy of prematurity (ROP). Previous clinical reports were contradictory and had one or more methodological flaws.


METHODS
The LIGHT-ROP trial was designed in rigorous fashion to include randomization to treatment or control groups, masking of examiners, an adequate sample size of high-risk infants, a universal ROP classification system, a reliable and reproducible ophthalmologic examination protocol, a controlled method of light reduction, and monitoring of light levels in the nursery. 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.


CONCLUSIONS
The design of the LIGHT-ROP study represents the most rigorous and largest clinical trial to date. It has demonstrated that light reduction does not reduce the incidence of confirmed ROP in high risk infants.
D006801:Humans; D007230:Infant, Low Birth Weight; D007231:Infant, Newborn; D008027:Light / Q000009:adverse effects; D011446:Prospective Studies; D015203:Reproducibility of Results; D012107:Research Design; D012178:Retinopathy of Prematurity / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D012683:Sensory Deprivation; D016896:Treatment Outcome