IMPORTANCE Previous studies of myo-inositol in preterm infants with respiratory distress found reduced severity of retinopathy of prematurity (ROP) and less frequent ROP, death, and intraventricular hemorrhage. However, no large trials have tested its efficacy or safety.OBJECTIVE To test the adverse events and efficacy of myo-inositol to reduce type 1 ROP among infants younger than 28 weeks' gestational age. DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial included 638 infants younger than 28 weeks' gestational age enrolled from 18 neonatal intensive care centers throughout the United States from April 17, 2014, to September 4, 2015 final date of follow-up was February 12, 2016. The planned enrollment of 1760 participants would permit detection of an absolute reduction in death or type 1 ROP of 7% with 90% power. The trial was terminated early due to a statistically significantly higher mortality rate in the myo-inositol group.INTERVENTIONS A 40-mg/kg dose of myo-inositol was given every 12 hours (initially intravenously, then enterally when feeding; n = 317) or placebo (n = 321) for up to 10 weeks. MAIN OUTCOMES AND MEASURES Type 1 ROP or death before determination of ROP outcome was designated as unfavorable. The designated favorable outcome was survival without type 1 ROP. RESULTS Among 638 infants (mean, 26 weeks' gestational age; 50% male), 632 (99%) received the trial drug or placebo and 589 (92%) had a study outcome. Death or type 1 ROP occurred more often in the myo-inositol group vs the placebo group (29% vs 21%, respectively; adjusted risk difference, 7% [95% CI, 0%-13%]; adjusted relative risk, 1.41 [95% CI, 1.08-1.83], P = .01). All-cause death before 55 weeks' postmenstrual age occurred in 18% of the myo-inositol group and in 11% of the placebo group (adjusted risk difference, 6% [95% CI, 0%-11%]; adjusted relative risk, 1.66 [95% CI, 1.14-2.43], P = .007). The most common serious adverse events up to 7 days of receiving the ending dose were necrotizing enterocolitis (6% for myo-inositol vs 4% for placebo), poor perfusion or hypotension (7% vs 4%, respectively), intraventricular hemorrhage (10% vs 9%), systemic infection (16% vs 11%), and respiratory distress (15% vs 13%).CONCLUSIONS AND RELEVANCE Among premature infants younger than 28 weeks' gestational age, treatment with myo-inositol for up to 10 weeks did not reduce the risk of type 1 ROP or death vs placebo. These findings do not support the use of myo-inositol among premature infants; however, the early termination of the trial limits definitive conclusions.

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Objective To describe baseline characteristics, initial postoperative refractive errors, operative complications, and magnitude of the intraocular lens (IOL) prediction error for refractive outcome in children undergoing lensectomy largely in North America. Design Prospective, registry study of children from birth to <13 years of age having undergone lensectomy for any reason within 45 days preceding enrollment. Participants 1,266 eyes of 994 children; 49% female and 59% white Testing Measurement of refractive error, axial length, and complete ophthalmic examination Main Outcome Measures Eye and systemic associated conditions, IOL style, refractive error, pseudophakic refraction prediction error, operative and perioperative complications Results Mean age at first eligible lens surgery was 4.2 years; 337 (34%) from birth to <1 year of age. Unilateral surgery was performed in 584 (59%) children. Additional ocular abnormalities were noted in 301 (24%) eyes. An IOL was placed in 35 of 460 (8%) eyes when surgery was performed prior to 1 year of age, in 70 of 90 (78%) eyes from 1 to <2 years of age, and in 645 of 716 eyes (90%) from 2 to <13 years of age. The odds of IOL implantation were greater in children ≥2 years of age than those <2 years of age (odds ratio=29.1; p<0.001; 95% confidence interval: 19.6 to 43.3). Intraoperative complications were reported for 69 (5%) eyes, with the most common being unplanned posterior capsule rupture in 14 eyes, 10 of which had an IOL placed. Prediction error of the implanted IOL was <1.00 D in 54% of eyes, but >2.00 D in 15% of eyes. Conclusions Lensectomy surgery was performed throughout childhood, with about two-thirds of cases performed after one year of age. Initial surgery appeared safe with a low complication rate. IOL placement was nearly universal in children 2 years of age and older. The immediate postoperative refraction was within 1 diopter of the target for about one-half of eyes.

Although many theories exist, the true cause of infantile esotropia remains unknown. The literature suggests that treatment before age 2 and perhaps even earlier improves the potential for binocular vision. After significant review of literature, it is clear that surgery is the treatment of choice for infantile esotropia but no method has a clear advantage. Efforts to define the best surgical procedure and timing of surgery through prospective, randomized multicenter trials are warranted.