Primary insertion of an intraocular lens during pediatric cataract surgery is the standard of care for children age 2 years and older. It’s also more common in infants, though concerns about adverse events, re-operations, and refractive changes continue to be serious considerations.

To evaluate these concerns, Erick D. Bothun, M.D., and a research team in Ophthalmology at Mayo Clinic in Rochester, Minnesota, conducted a retrospective review of infants ages 7 to 24 months treated by surgeons at 10 Infant Aphakia Treatment Study (IATS) sites.

The 10 IATS sites registered 96 infants ages 7 to 24 months with a history of unilateral cataract surgery between 2004 and 2010. Ultimately, TAPS, an earlier study, included 56 infants.
Surgery was performed on the right eye in 31 infants (55%) and the left eye in 25 infants (45%). A primary intraocular lens was inserted in 51 infants (91%). Intraocular lenses were implanted in 20 of 24 infants (83%) who were 7 to 12 months of age, and in 31 of 32 infants (97%) who were 13 to 24 months of age.

Clinical and surgical records were reviewed for visual acuity, refractive correction, patching compliance, intraocular pressure, ocular motility, anterior segment and ocular fundus examination findings. The final study visit occurred when the infants were between 4 and 6 years of age. Other patient details included gender, age at surgery, cataract description, strabismus measurements, and intraocular lens power.

Study outcomes

Intraoperative complications and adverse events were recorded using the IATS criteria. Complications occurred in 7% of infants. Unplanned intraocular surgery occurred in 14% of infants. Adverse events were identified in 24%, with a 4% incidence of glaucoma suspect. Strabismus surgery was performed in 40% of the infants with strabismus before 4 years of age.

Visual acuity, strabismus, stereopsis and glaucoma outcomes were not statistically different between the study groups. Neither adverse events nor intraocular re-operations were more common for infants with surgery at 7 to 12 months of age than for those who underwent surgery at 13 to 24 months of age.

“Although most infants in TAPS between 7 months and 2 years of age underwent intraocular lens implantation concurrent with unilateral cataract removal, the incidences of complications, re-operations and glaucoma appear much lower than when intraocular lenses were used by the same surgeons in infants younger than 7 months of age in the IATS,” says Dr. Bothun. For infants who received an intraocular lens in IATS, intraoperative complications occurred in 28%, adverse events in 81%, and additional intraocular surgeries in 72%.

“Due to inflammatory risks, structural challenges and characteristics of eye growth, the IATS, and other efforts showed that cataract surgery risks increase in infancy compared with older children and teenagers. Before TAPS, the literature lacked documentation regarding cataract surgery outcomes in infants just older than the IATS group. The TAPS findings support the relatively safe use of intraocular lenses in infants between 7 and 24 months of age,” says Dr. Bothun.


IATS Study

The Infant Aphakia Treatment Study Group. Comparison of contact lens and intraocular lens correction of monocular aphakia during infancy: A randomized clinical trial of HOTV optotype acuity at age 4.5 years and clinical findings at age 5 years. JAMA Ophthalmology. 2014;132:676.

TAPS Study

Outcomes of unilateral cataracts in infants and toddlers 7 to 24 months of age: Toddler Aphakia and Pseudophakia Study (TAPS). Ophthalmology. 2019;126:1189.