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Lambert SR, Cotsonis G, DuBois L, Nizam Ms A, Kruger SJ, Hartmann EE, Weakley DR, Drews-Botsch C, Infant Aphakia Treatment Study Group. Long-term Effect of Intraocular Lens vs Contact Lens Correction on Visual Acuity After Cataract Surgery During Infancy: A Randomized Clinical Trial. JAMA ophthalmology. 2020;138:365-372. PMID 32077909

One-paragraph summary

The Infant Aphakia Treatment Study (NCT00212134) randomised 114 infants with unilateral congenital cataract, operated between 1 and 6 months of age at 12 US sites, to primary intraocular lens implantation or aphakia corrected with a contact lens. Best-corrected visual acuity by the electronic ETDRS protocol was obtained at age 10.5 years in 110 of 114 (96%). Median treated-eye acuity was 0.89 logMAR (IQR 0.33–1.43; Snellen ≈20/159) with an IOL and 0.86 logMAR (IQR 0.30–1.46; ≈20/145) with aphakia (P = 0.82; 99% CI for the difference in medians −0.54 to 0.47). Overall 27 children (25%) achieved 0.30 logMAR (20/40) or better — 12 (22%) in the IOL group and 15 (27%) in the aphakia group — while 50 children (44%) had 1.00 logMAR (20/200) or worse, 25 (44%) in each group. Implanting an IOL at the time of cataract extraction was neither beneficial nor detrimental to the visual outcome.

Key findings

  • Median treated-eye acuity at 10.5 years: 0.89 vs 0.86 logMAR, P = 0.82.
  • Good acuity (≤0.30 logMAR): 25% overall; poor acuity (≥1.00 logMAR): 44% overall.
  • No visual advantage from primary IOL, at either 1 year (Lambert 2010, PMID 20457949), 5 years or 10.5 years.
  • The surgical burden of primary IOL is large: intraoperative complications 28% vs 11% (P = 0.031), adverse events 81% vs 56% (P = 0.008) and additional intraocular surgeries 72% vs 16% (P < 0.0001) over five years (Plager 2014, PMID 25077835).
  • Glaucoma risk is time-dependent and IOL-independent: glaucoma 9% at 1 year, 17% at 5 and 22% at 10 years; glaucoma-or-suspect 12%, 31% and 40% (Freedman 2021, PMID 33331850).
  • Aphakia is often temporary — 22 of 51 (43%) children left aphakic to 4.5 years received a secondary IOL by 10.5 years (Drews-Botsch 2026, PMID 41962549).

Limitations

  • 114 infants: adequately powered for the primary comparison, not for identifying which subgroups might benefit from a primary IOL.
  • Unilateral disease only; bilateral congenital cataract has a different amblyopia structure and better operated-eye outcomes (Bothun 2020, PMID 31987642).
  • Outcome is acuity in the treated eye; binocularity, stereopsis and strabismus are secondary analyses (Bothun 2022, PMID 35843488).
  • Contact-lens arm results depend on adherence and family capacity, which were measured but not randomised (Cromelin 2018, PMID 29423513).
  • US tertiary centres; transferability to settings without reliable contact-lens supply is untested.

Why it matters

IATS is the only adequately powered randomised trial answering the central question of infant cataract management, and its answer — no visual difference, far more surgery with an IOL — reversed a drift toward routine primary implantation. It also produced the field's best long-term data on aphakic glaucoma, which turned out to rise steadily with follow-up and to be predicted by preoperative anterior chamber depth (OR 5.8, 95% CI 1.8–18.9) rather than by lens status (Wong 2026, PMID 41419074). The 25%/44% good/poor acuity split is the honest number to quote to families, and it has not moved across two decades of technique refinement.

Cited by wiki pages

  • congenital-and-paediatric-cataract
  • overview
  • clinical-trials-landscape