Objective
To evaluate the characteristics of strabismus in infants who underwent cataract surgery with and without intraocular lens (IOL) implantation.
Design
Secondary outcome analysis in a prospective, randomized clinical trial
Participants
The Infant Aphakia Treatment Study (IATS) is a randomized, multicenter (n = 12) clinical trial comparing treatment of aphakia with a primary IOL or contact lens in 114 infants with a unilateral congenital cataract.
Intervention
Infants underwent cataract surgery with or without placement of an IOL.
Main Outcome Measures
The proportion of patients who developed strabismus during the first 12 months of follow-up was calculated using the life-table method, and compared across treatment groups and age strata using a log-rank test.
Results
Strabismus developed within the first 12 months of follow-up in 38 (life table estimate: 66.7%) pseudophakic infants and 42 (life table estimate: 74.5%) infants treated with contact lenses (p=0.59). The younger cohort (< 49 days) at the time of surgery developed less strabismus (29 of 50, life table estimate: 58.0%) than the older cohort (≥ 49 days) (51 of 64, life table estimate: 80.0%) (p<0.01).
Conclusions
Intraocular lens placement does not prevent the early development of strabismus following congenital cataract surgery. However, strabismus was less likely to develop in infants whose cataract was removed at an earlier age.