Table 5.

Progression to Threshold ROP* by Ophthalmic Characteristics and Treatment Assignment

CharacteristicConventionalSupplementalTotal
n%n%n%
Enrolled325100%324100%649100%
 Without eye endpoints 268% 268% 528%
 With eye endpoints29992%29892%59792%
Infants with eye endpoints299100%298100%597100%
 Progression to threshold14548%12241%26745%
 Stratum A (progressed/total)46 /8455%37 /8146%83 /16550%
  Fellow eye worse than PT8 /1362%8 /1457%16 /2759%
  At least 1 study eye zone I38 /7154%29 /6743%67 /13849%
 Stratum B (progressed/total)99 /21546%85 /21739%184 /43243%
  Both eyes zone II PT80 /15253%66 /15243%146 /30448%
  1 eye less than PT19 /6330%19 /6529%38 /12830%
Infants with zone I ROP, in at least 1 eye46 /8256%41 /8349%87 /16553%
Infants with zone II ROP99 /21746%81 /21537%180 /43242%
Plus disease infants§54 /10352%59 /10357%113 /20655%
Non-plus disease infants§91 /19646%63 /19532%154 /39139%
Time elapsed from randomization
 All study eyes
  To adverse outcome, wk2.4 ± 2.02.7 ± 2.02.5 ± 2.0
  To favorable if resolved, wk9.0 ± 3.89.5 ± 4.09.2 ± 3.9
 Eyes <PT ROP at randomization14/62 (22.6%)14/61 (23.0%)28/123 (22.8%)
  To adverse outcome, wk1.7 ± 1.13.2 ± 1.32.4 ± 1.4
  To favorable outcome, wk7.8 ± 3.88.2 ± 3.98.0 ± 3.8
 Eyes without plus disease
  To adverse outcome, wk2.3 ± 2.12.7 ± 2.02.5 ± 2.1
  To favorable outcome, wk8.9 ± 4.09.5 ± 4.19.2 ± 4.1
 Eyes with plus disease
  To adverse outcome, wk1.6 ± 1.02.2 ± 1.91.9 ± 1.6
  To favorable outcome, wk7.5 ± 2.97.1 ± 3.37.3 ± 3.1
  • * Infant ophthalmic outcomes based on progression of at least 1 study eye to threshold ROP. If an infant entered the study with 1 eye already at threshold or worse, that eye was not a study eye, and the infant's outcome is based on only the study eye.

  • “Eye endpoints” means that for that infant, the primary endpoint of either 1) at least 1 eye progressing to threshold, or 2) all study eyes not progressing to threshold is known.

  • PT indicates prethreshold ROP.

  • § “Plus disease infants” are those who have at least 2 quadrants of posterior pole dilation/tortuosity in at least 1 study eye, whereas “non-plus disease infants” have all study eyes with 0 or 1 quadrant of posterior pole dilation/tortuosity.

  • Mean ± standard deviation.