Correspondence: Five-year postoperative outcomes of bilateral aphakia and pseudophakia in children up to 2 years of age: A randomized clinical trial

We read with interest the recent article by Vasavada et al¹ reporting the results of their clinical trial randomizing children <2 years with bilateral cataracts to intraocular lens (IOL) implantation or aphakia. They reported a lower incidence of visual axis opacities (VAO) in the pseudophakic group than did the Infant Aphakia Treatment Study (IATS) while reporting similar visual acuities in the two treatment groups.² The low incidence of VAO in the Vasavada study is to be commended, however, the patient populations in these studies differed in two important ways that make comparison difficult. First, the median age of the children undergoing IOL implantation was quite different: IATS=1.8 months; Vasavada=6.0 months. The rate of VAO is much higher after cataract surgery in children <6 months of age even when performed by an experienced surgeon.³ Second, all patients in the IATS had unilateral cataracts, 63% of which were persistent fetal vasculature (PFV) or nuclear, whereas no patients in the Vasavada study had PFV and the number of nuclear cataracts is unknown. In particular, PFV is associated with a higher incidence of adverse events.⁴ Most patients in the Vasavada study had lamellar or total cataracts compared to <4% of the IATS patients.

Vasavada et al reported that only 2 of 30 (6%) patients randomized to aphakia in their study wore contact lenses for >1 year. In contrast, contact lens wear averaged over 90% for the children randomized to aphakia in the IATS.⁵ Vasavada et al attributed this difference to the fact that parents were not charged for contact lenses in the IATS and “monitoring of compliance was performed by regular home visits by trained personnel.” While it is true that contact lenses were provided at no cost to parents in the IATS, home visits were not part of the IATS protocol.²

The Vasavada protocol mandated that patients undergo an examination-under-anesthesia every 3 months for the first postoperative year and then every 6 months until age 5 years. Assuming that a patient undergoing cataract surgery at age 6 months returned for each examination, they would have received general anesthetics 13 times by age 5 years. Because of concerns about the neurotoxicity of general anesthesia in young children, general anesthesia was reserved for children undergoing additional surgeries in the IATS.⁶ In fact the need for additional general anesthetics for children in the pseudophakic group was one of the primary reasons we advised against primary IOL implantation in infants unless “the cost and handling of a contact lens would be so burdensome as to result in significant periods of uncorrected aphakia.”² We congratulate Dr. Vasavada and coworkers on their excellent surgical outcomes in a challenging patient population and we agree that IOLs are a good option for children >6 months of age. However, for the reasons stated and for long-term refractive considerations not addressed in their paper, we still believe that it is generally better to leave infants <6 months of age aphakic after cataract surgery and to correct their aphakia with contact lenses or spectacles.