Objectives: To determine and compare the incidence of severe, vision-t
hreatening retinopathy of prematurity (ROP) in black and white low-bir
th-weight infants. Design: Prospective cohort study. Setting: Seventy
neonatal intensive care units in 23 US participating centers in the Mu
lticenter Trial of Cryotherapy for Retinopathy of Prematurity. Patient
s: A total of 4099 premature infants weighing less than 1251 g at birt
h were enrolled to evaluate the natural history of ROP. This 'Natural
History' cohort included 2158 white infants and 1584 black infants who
were followed up prospectively according to a Natural History protoco
l. Main Outcome Measures: Incidence and severity of acute ROP. Results
: While ROP occurred with similar frequency in all racial subgroups, s
evere ROP was less common in black infants. One hundred sixty (7.4%) o
f 2158 white infants reached threshold ROP (defined as at least 5 cont
iguous or 8 cumulative clock-hours of stage 3 retinopathy in zone 1 or
zone 2 in the presence of ''plus disease'' [dilation and tortuosity o
f the posterior pole blood vessels]), but only 51 (3.2%) of 1584 black
infants progressed to threshold ROP. Using multiple logistic regressi
on analysis, race emerged as a highly significant factor (P < .001) in
the development of threshold disease, even when birth weight, gestati
onal age status at delivery, sex, multiple births, and transport statu
s were considered. Conclusions: Severe, vision-threatening ROP occurs
with greater frequency in low-birth-weight white infants than in low-b
irth-weight black infants who are seemingly at equivalent risk. The re
ason for this disparity is unknown. We speculate that differences in r
etinal pigmentation may confer relative protection against free radica
l-mediated phototoxic injury in black infants.