Importance The efficacy and safety of primary intraocular lens (IOL) implantation during early infancy is unknown. Objective To compare the visual outcomes of patients optically corrected with contact lenses vs IOLs following unilateral cataract surgery during early infancy. Design, Setting, and Participants The Infant Aphakia Treatment Study is a randomized clinical trial with 5 years of follow-up that involved 114 infants with unilateral congenital cataracts at 12 sites. A traveling examiner assessed visual acuity at age 4.5 years. Interventions Cataract surgery with or without primary IOL implantation. Contact lenses were used to correct aphakia in patients who did not receive IOLs. Treatment was determined through random assignment. Main Outcomes and Measures HOTV optotype visual acuity at 4.5 years of age. Results The median logMAR visual acuity was not significantly different between the treated eyes in the 2 treatment groups (both, 0.90 [20/159]; P  = .54). About 50% of treated eyes in both groups had visual acuity less than or equal to 20/200. Significantly more patients in the IOL group had at least 1 adverse event after cataract surgery (contact lens, 56%; IOL, 81%; P  = .02). The most common adverse events in the IOL group were lens reproliferation into the visual axis, pupillary membranes, and corectopia. Glaucoma/glaucoma suspect occurred in 35% of treated eyes in the contact lens group vs 28% of eyes in the IOL group ( P  = .55). Since the initial cataract surgery, significantly more patients in the IOL group have had at least 1 additional intraocular surgery (contact lens, 21%; IOL, 72%; P Conclusions and Relevance There was no significant difference between the median visual acuity of operated eyes in children who underwent primary IOL implantation and those left aphakic. However, there were significantly more adverse events and additional intraoperative procedures in the IOL group. When operating on an infant younger than 7 months of age with a unilateral cataract, we recommend leaving the eye aphakic and focusing the eye with a contact lens. Primary IOL implantation should be reserved for those infants where, in the opinion of the surgeon, the cost and handling of a contact lens would be so burdensome as to result in significant periods of uncorrected aphakia. Trial Registration clinicaltrials.gov Identifier:NCT00212134

https://jamanetwork.com/journals/jamaophthalmology/articlepdf/1838344/eoi140024.pdf

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.

Purpose To evaluate the stability of 2.2 mm and 3.0 mm clear corneal cataract incisions with square or nearly square surface architecture. Setting Private practice ambulatory surgical center, Century City, California, USA. Methods A retrospective chart review of 60 patients who had clear corneal cataract extraction between January and September 2006 was conducted. Fifty patients had clear corneal cataract extraction with a square 2.2 mm incision and 10 patients with a nearly square 3.0 mm incision. For the 2.2 mm incision subset, cataract surgery and intraocular lens implantation were accomplished through an unenlarged 2.2 mm clear corneal cataract incision using the Alcon Infiniti unit and an Ultrasleeve for infusion. For the 3.0 mm subset, the Allergan Sovereign unit was used. Intraocular pressure (IOP) was measured intraoperatively at the conclusion of each procedure with a Schiotz or Barraquer tonometer and set between 15 mm Hg and 20 mm Hg. Wound sealing was confirmed by intraoperative Seidel testing in all cases. Intraocular pressure was measured by a Tono-Pen (Medtronic) or Goldmann applanation tonometry between 2 hours and 6 hours after the conclusion of each procedure. Results The mean postoperative IOP was 19.2 mm Hg ± 4.9 (SD) (median 18 mm Hg; range 11 to 35 mm Hg) in the group with a 2.2 mm square incision and 16.6 ± 5.2 mm Hg (median 16.0 mm Hg; range 10 to 25 mm Hg) in the group with a 3.0 mm nearly square clear corneal incision. No patient had an IOP less than 10 mm Hg, and there was no evidence of hypotony or wound leakage by Seidel testing in either group. Conclusions Clear corneal wounds of square or nearly square surface architecture that are meticulously checked for sealing were stable postoperatively as demonstrated by the absence of hypotony and wound leakage. In the presence of a sealed clear corneal wound, IOP remained reasonably stable relative to the level set at the conclusion of the procedure.

Proper wound construction to prevent short-term ocular hypotony after clear corneal incision cataract surgery.

Importance Although intraocular lenses (IOLs) are often implanted in children, little is known whether primary IOL implantation or aphakia and contact lens correction results in better long-term visual outcomes after unilateral cataract surgery during infancy. Objective To compare long-term visual outcomes with contact lens vs IOL correction following unilateral cataract surgery during infancy. Design, Setting, and Participants This multicenter randomized clinical trial enrolled 114 infants with a unilateral congenital cataract who underwent cataract surgery with or without primary IOL implantation between 1 and 6 months of age. Data on long-term visual outcomes were collected when the children were age 10.5 years (July 14, 2015, to July 12, 2019) and analyzed from March 30 through August 6, 2019. Interventions Intraocular lens implantation at the time of cataract surgery. Main Outcomes and Measures Best-corrected visual acuity using the electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) testing protocol. Analysis was performed on an intention-to-treat basis. Results Best-corrected visual acuity was measured at age 10.5 years for 110 of the 114 patients (96%) enrolled as infants. The participants included 58 girls (53%) and 52 boys (47%). Overall, 27 of the children (25%) had good (logMAR 0.30 [Snellen equivalent, 20/40] or better) visual acuity in the treated eye (12 [22%] in the IOL group and 15 [27%] in the aphakia group), but 50 children (44%) had a visual acuity of logMAR 1.00 (Snellen equivalent, 20/200) or worse (25 [44%] in the IOL group and 25 [44%] in the aphakia group). The median logMAR acuity in the treated eye was similar in children randomized to receive an IOL at the time of cataract extraction (0.89; interquartile range [IQR], 0.33-1.43 [Snellen equivalent, 20/159]) and those who remained aphakic (0.86; IQR, 0.30-1.46 [Snellen equivalent, 20/145]) (IQR, 0.30-1.46;P = .82). Although the overall difference in median visual acuity between the 2 groups was small, the estimate was imprecise (99% CI for the difference in medians was −0.54 to 0.47). Conclusions and Relevance As in previous phases of the study, visual acuity outcomes were highly variable with only 27 children (25%) achieving excellent visual acuity in their treated eye and 50 children (44%) having poor vision in the treated eye. Implanting an IOL at the time of cataract extraction was neither beneficial nor detrimental to the visual outcome. Trial Registration ClinicalTrials.gov Identifier:NCT00212134

/pdf/long-term-effect-of-intraocular-lens-vs-contact-lens-280wxzyuln.pdf

Long-term Effect of Intraocular Lens vs Contact Lens Correction on Visual Acuity After Cataract Surgery During Infancy: A Randomized Clinical Trial

Outcomes of Bilateral Cataracts Removed in Infants 1 to 7 Months of Age Using the Toddler Aphakia and Pseudophakia Treatment Study Registry.

Five-Year Postoperative Outcomes of Bilateral Aphakia and Pseudophakia in Children up to 2 Years of Age: A Randomized Clinical Trial.

Reply: To PMID 25077835.

Outcomes of Unilateral Cataracts in Infants and Toddlers 7 to 24 Months of Age: Toddler Aphakia and Pseudophakia Study (TAPS).

After Sir Harold Ridley’s invention of the intraocular lens (IOL) in 1949, Dr. Edward Epstein implanted an IOL in a 12-year-old aphakic child in 1952. However, implantation in pediatric eyes was slow to catch on as many early attempts at IOL implantation in children resulted in complications. These results have been attributed to a lack of awareness of the need for primary posterior capsulectomy and vitrectomy, poor IOL design for children, and the inherent propensity for an increased inflammatory response in a child’s eye after intraocular surgery. Advances in surgical techniques and technologies resulted in a reduction in the postsurgical inflammatory response, even in the highly reactive eyes of children. Improvements in IOL design are important contributing factors in this regard. Implantation of IOLs in children began to increase steadily in the 1980s and early 1990s. This increase was the result of the introduction of poly(methylmethacrylate) (PMMA) IOLs, which were highly polished, downsized to 12.0 mm overall length, and equipped with more flexible haptics. In addition, the use of mechanized vitrectomy instrumentation to selectively perform a primary posterior capsulectomy and vitrectomy combined with IOL implantation resulted in fewer reoperations in younger children. Soon after its introduction in the mid 1990s, the hydrophobic acrylic IOL assumed a prominent role in adult cataract surgery. Because posterior capsule opacification (PCO) is one of the most frequent and severe complications in pediatric cataract surgery, reports that acrylic IOLs decreased the incidence of PCO after adult cataract surgery prompted pediatric cataract surgeons to use this material in pediatric eyes. The

ASCRS white paper. Hydrophobic acrylic intraocular lenses in children.

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Reply: To PMID 25077835.

Outcomes of Unilateral Cataracts in Infants and Toddlers 7 to 24 Months of Age: Toddler Aphakia and Pseudophakia Study (TAPS).

ASCRS white paper. Hydrophobic acrylic intraocular lenses in children.