Abstract
Purpose:
Compare infant characteristics and ROP status in 3 clinical studies conducted in a 27-year period in the US.
Methods:
Common baseline infant characteristics and ROP onset, severity, and time course of ROP were determined using retrospective review of CRYO-ROP and ETROP publications (Ophthalmology 1991;98:1628-40, Pediatrics 2005;116:15-23) and the primary data from e-ROP (JAMA Ophthalmology 2014;132:1178). All three studies enrolled infants with birth weight of <1251g.
Results:
The CRYO-ROP study enrolled 4099 infants from January 1986 through November 1987 and the ETROP Trial screened 6998 babies for a prospective study to detect prethreshold ROP from October 2000 through September 2002. The e-ROP examined 1257 infants from May 2011 through October 2013. Across the three studies, mean birth weight (BW) and gestational age (GA) decreased from CRYO-ROP [954g (185), 27.9 (2.2)] to ETROP [907g (205), 27.4 (2.2)] to e-ROP [864g (212), 27.0 (2.2), p<0.0001] with an increase in % infants enrolled <750g (15.8% CRYO, 24.9% ETROP, 33.4% e-ROP, p<0.0001). The percentage of infants who developed ROP varied (65.8% CRYO, 68.0% ETROP, 63.7% e-ROP, p=0.003). Moderately severe ROP (defined as prethreshold or referral-warranted) varied somewhat (17.8% CRYO, 12.3% ETROP, 19.4% e-ROP, p<0.0001), while the onset of any ROP varied little (34.3wks CRYO, 34.1wks ETROP, 34.8wks e-ROP) as did onset of stage 3 ROP and plus disease.
Conclusions:
BW and GA of infants enrolled in ROP studies have decreased over the last 27 years in the US, while ROP prevalence and onset of disease are less variable.