Elsevier

Ophthalmology

Volume 118, Issue 12, December 2011, Pages 2330-2334
Ophthalmology

Original article
Complications, Adverse Events, and Additional Intraocular Surgery 1 Year After Cataract Surgery in the Infant Aphakia Treatment Study

https://doi.org/10.1016/j.ophtha.2011.06.017Get rights and content

Purpose

To compare rates and severity of complications between infants undergoing cataract surgery with and without intraocular lens (IOL) implantation.

Design

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 unilateral congenital cataract.

Intervention

Infants underwent cataract surgery with or without placement of an IOL.

Main Outcome Measures

The rate, character, and severity of intraoperative complications (ICs), adverse events (AEs), and additional intraocular surgeries (AISs) during the first postoperative year in the 2 groups were analyzed.

Results

There were more patients with ICs (28% vs. 11%; P = 0.031), AEs (77% vs. 25%; P<0.0001), and AISs (63% vs. 12%; P<0.0001) in the IOL group than the contact lens group. Iris prolapse was the most common IC. The most common AE was visual axis opacification, and the most common additional intraocular reoperation was a clearing of visual axis opacification.

Conclusions

The rates of ICs, AEs, and AISs 1 year after surgery were numerically higher in the IOL group, but their functional impact does not clearly favor either treatment group.

Financial Disclosure(s)

The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Section snippets

Patients and Methods

The study design, surgical techniques, follow-up schedule, and patient characteristics at baseline have been reported in detail previously and are only summarized here.7 This study was approved by the institutional review boards of all participating institutions and was in compliance with the Health Insurance Portability and Accountability Act. The off-label research use of the AcrySof SN60AT and MA60AC IOLs (Alcon Laboratories, Fort Worth, TX) was covered by United States Food and Drug

Intraoperative Complications

There were more patients with ICs reported in the IOL group, 16 (21%), than the CL group, 6 (11%; P = 0.031). There were a total of 22 ICs in 16 IOL patients. Of these, iris prolapse was the most common (n = 12), followed by iris damage (n = 3), and hyphema (n = 2). There was one occurrence each of retained cortex, corneal clouding, iris sphincterotomy, lens fragment in the vitreous, and inadvertent rupture of the posterior capsule.

More specifically in the IOL group, the following complications

Discussion

The decision regarding whether to implant an IOL in an infant eye at the time of surgery for congenital cataract, as with any surgery, requires balancing the expected benefit of the surgery against the risks associated with the procedure. One of the potential benefits of placing an IOL at the time of infant cataract surgery and the primary outcome measure of the IATS is the visual acuity. At 1 year, the acuity in the 2 groups was not different.8 This measure will be reassessed in all study

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Members of the Infant Aphakia Treatment Study Group are listed in Appendix 1, available at http://aaojournal.org.

Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Supported by the National Institutes of Health, Bethesda, Maryland (grant nos.: U10 EY13272 and U10 EY013287; and Departmental Core Grant no.: EY06360); and in part by Research to Prevent Blindness, Inc., New York, New York.

Manuscript no. 2011-483.

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