Table 3.

Baseline Ophthalmic Characteristics By Treatment Group

CharacteristicConventionalSupplementalTotal
 n      % n      % n      %
325100%324100%649100%
Stratum A—at least 1 eye PT ROP*
 Fellow eye worse than PT144.3%144.3%284.3%
 At least 1 eye zone I7723.7%7523.2%15223.4%
Stratum B—at least 1 eye PT
 Both eyes zone II PT16751.4%16450.6%33151.0%
 1 eye less than PT6720.6%7121.9%13821.3%
Infants with zone I ROP8827.1%9128.1%17927.6%
Infants with zone II ROP23772.9%23371.9%47072.4%
Plus disease infants10732.9%11234.6%21933.7%
Non-plus disease infants21867.1%21265.4%43066.3%
Time from first§ PT diagnosis to randomization (infants in category)
 ≤24 h11535.5%10031.6%21533.2%
 >24, ≤48 h12739.2%12839.6%25539.4%
 >48 h8225.3%9529.4%17727.4%
 Missing112
  • * PT indicates prethreshold retinopathy of prematurity.

  • Note that in stratum A, infants with bilateral zone I ROP and 1 eye already at threshold or beyond, are categorized as “fellow eye worse than prethreshold.”

  • Plus disease is defined as present when there is posterior pole vascular dilation and tortuosity in at least 2 quadrants. An infant is a plus disease infant if at least 1 study eye has plus disease at baseline. Similarly, an infant is a zone I infant if at least 1 study eye has zone I ROP.

  • § “First PT diagnosis” is the date/time of the first examination that showed prethreshold ROP in at least 1 eye that was subsequently confirmed on a second examination.