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Glaucoma-Related Adverse Events in the Infant Aphakia Treatment Study 1-Year Results

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Glaucoma-Related Adverse Events in the Infant Aphakia Treatment Study 1-Year Results CLINICAL SCIENCES ONLINE FIRST Glaucoma-Related Adverse Events in the Infant Aphakia Treatment Study 1-Year Results Allen D. Beck, MD; Sharon F. Freedman, MD; Michael J. Lynn, MS; Erick Bothun, MD; Daniel E. Neely, MD; Scott R. Lambert, MD; for the Infant Aphakia Treatment Study Group Objectives: To report the incidence of glaucoma and glau- sistent fetal vasculature and 1.6 times higher for each coma suspects in the IATS, and to evaluate risk factors for month of age younger at cataract surgery. the development of a glaucoma-related adverse event in patients in the IATS in the first year of follow-up. Conclusions: Modern surgical techniques do not elimi- nate the early development of glaucoma following con- Methods: A total of 114 infants between 1 and 6 months genital cataract surgery with or without an intraocular of age with a unilateral congenital cataract were as- lens implant. Younger patients with or without persis- signed to undergo cataract surgery either with or with- tent fetal vasculature seem more likely to develop a glau- out an intraocular lens implant. Standardized defini- coma-related adverse event in the first year of follow- tions of glaucoma and glaucoma suspect were created and up. Vigilance for the early development of glaucoma is used in the IATS. needed following congenital cataract surgery, especially when surgery is performed during early infancy or for a Results: Of these 114 patients, 10 (9%) developed glau- child with persistent fetal vasculature. Five-year fol- coma and 4 (4%) had glaucoma suspect, for a total of 14 low-up data for the IATS will likely reveal more glaucoma- patients (12%) with a glaucoma-related adverse event in related adverse events. the treated eye through the first year of follow-up. Of the 57patients who underwent lensectomy and anterior vi- Trial Registration: clinicaltrials.gov Identifier: trectomy, 5 (9%) developed a glaucoma-related adverse NCT00212134 event; of the 57 patients who underwent an intraocular lens implant, 9 (16%) developed a glaucoma-related ad- Arch Ophthalmol. 2012;130(3):300-305. verse event. The odds of developing a glaucoma-related Published online November 14, 2011. adverse event were 3.1 times higher for a child with per- doi:10.1001/archophthalmol.2011.347 LAUCOMA IS AN IMPOR- tomy performed at the time of cataract sur- tant complication of pe- gery.2-10 Cataract surgery in the first year Author Affiliations: Emory Eye diatric cataract surgery, of life and a small corneal diameter have Center (Dr Beck) and with a wide range of re- been the most consistent risk factors for Department of Ophthalmology, ported frequencies of oc- glaucoma development in reported stud- School of Medicine (Drs Beck currence, depending on the definition used ies.3,5-10 The effect of the placement of an and Lambert), and Department G 1-3 and the length of follow-up. Two large, intraocular lens (IOL) at the time of cata- of Biostatistics and 4,5 Bioinformatics, Rollins School retrospective series reported a 15% to ract surgery on the risk of developing glau- of Public Health (Mr Lynn), 21% frequency of glaucoma being diag- coma is unknown, although one retro- 11 Emory University, Atlanta, nosed 5 years after cataract surgery. Nu- spective review suggested a decreased Georgia; Duke Eye Center, merous risk factors for the development incidence of glaucoma in patients who re- Durham, North Carolina of glaucoma have been noted, including ceived an IOL. However, the eyes that re- (Dr Freedman); Departments of cataract surgery in the first year of life, ceived an IOL in that report11 were older Ophthalmology and Pediatrics, at the time of surgery (mean age, 5.1 years University of Minnesota, for pseudophakia vs 2.7 years for apha- Minneapolis (Dr Bothun); and See also page 293 kia), and children with corneal diam- Department of Ophthalmology, eters less than or equal to 10 mm were ex- Indiana University, Indianapolis postoperative complications such as sec- 9,10 (Dr Neely). cluded from analysis. Other studies have Group Information: The ondary membrane surgery, small corneal noted similar rates of glaucoma in apha- members of the Infant Aphakia diameters, type of cataract, a family his- kic and pseudophakic children who had Treatment Study Group (IATS) tory of aphakic glaucoma, and primary cataract surgery performed in the first year are listed on page 304. posterior capsulotomy/anterior vitrec- of life. ARCH OPHTHALMOL / VOL 130 (NO. 3), MAR 2012 WWW.ARCHOPHTHALMOL.COM 300 ©2012 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/26/2021 The Infant Aphakia Treatment Study (IATS) is a mul- and/or axial length, (3) increased optic nerve cupping defined ticenter, randomized, controlled clinical trial sponsored as an increase of 0.2 or more in the cup-to-disc ratio, or (4) by the National Eye Institute. The objective of the study the use of a surgical procedure for IOP control. A patient was is to compare the use of primary IOL implantation to sur- designated as a glaucoma suspect if he or she had 2 consecu- gery without IOL implantation in infants with a unilat- tive IOP readings above 21 mm Hg on different dates after topi- cal corticosteroids had been discontinued without any of the eral congenital cataract removed between 1 and 6 months anatomical changes listed above or if he or she had received of age. The results of the IATS during the first year after glaucoma medication to control IOP without any of the ana- cataract surgery (including visual acuities, number of ad- tomical changes listed above. verse events, and number of additional surgery) have been 12 previously reported. In our study, we report the devel- ASSESSMENT OF IOP, OCULAR DIMENSIONS, opment of glaucoma-related adverse events in IATS pa- AND OPTIC NERVE tients through 1 year of follow-up. The investigator could perform tonometry with a Tono-Pen (Rei- METHODS chert, Depew, New York), a handheld Goldmann applanation tonometer, or a pneumatonometer. A protocol assessment of The study design, surgical technique, follow-up schedule, patch- IOP was performed at the initial examination of the patient un- ing and optical correction regimens, evaluation methods, and der anesthesia (ie, immediately after the induction of anesthe- patient characteristics at baseline have been previously re- sia prior to randomization and surgery) and at an examination ported in detail13 and are therefore only briefly summarized in of the patient under anesthesia at 1 year of age. All other IOP this report. Our study was approved by the institutional re- measurements were performed at the discretion of the princi- view boards of all the participating institutions and was in com- pal investigator. Corneal diameters (measured using cali- pliance with the Health Insurance Portability and Accountabil- pers), axial length assessment (A-scan biometry using immer- ity Act. The off-label research use of the Acrysof SN60AT and sion or applanation techniques), and indirect ophthalmoscopy MA60AC IOLs (Alcon Laboratories, Fort Worth, Texas) was of the optic nerve were also part of the protocol assessment dur- covered by US Food and Drug Administration investigational ing examination of the patient under anesthesia prior to ran- device exemption G020021. domization and at 1 year of age. STUDY DESIGN STATISTICAL CONSIDERATIONS The main inclusion criteria were a visually significant congen- Statistical comparisons were made between patients with and pa- ital cataract (Ն3 mm central opacity) in 1 eye and an age range tients without a glaucoma-related adverse event by using the of 28 days to less than 210 days at the time of cataract surgery. Fisher exact test for percentages, the independent groups t test Patients with a unilateral cataract due to persistent fetal vas- for means, and the Wilcoxon rank sum test for medians. The non- culature (PFV) were allowed in our study as long as the PFV parametric test was used for factors that were highly skewed (age was not associated with visible stretching of the ciliary pro- at surgery and visual acuity at 1 year of age). The exact bino- cesses or with involvement of the retina or optic nerve as de- mial method was used to compute the 95% CI for a proportion, termined by the treating IATS investigator. The other main ex- and the normal approximation was used to compute the 95% clusion criteria were an acquired cataract, a corneal diameter CI for the difference between 2 proportions. Stepwise logistic re- of less than 9 mm, and prematurity (Ͻ36 gestational weeks). gression was used to assess the relationship between the devel- Patients were randomly assigned to have either an IOL placed opment of glaucoma and a selected set of patient characteris- at the time of the initial surgery (with spectacle correction) or tics: age at surgery, diagnosis of PFV, and corneal diameter. A ␹2 to be left aphakic (with contact lens correction). Patients were significance level of .10 was set for the Wald statistic for in- examined at 1 day, 1 week, and 1, 3, 6, 9, and 12 months after cluding and retaining independent variables in the logistic re- surgery. Grating visual acuity was measured at 1 year of age gression model, and 90% CIs were calculated for the odds ra- Ͻ (±2 months) by a traveling examiner using Teller Acuity Cards tios. For all other analyses, a P .05 was considered statistically (Stereo Optical, Chicago, Illinois). significant, and 95% CIs were computed. No adjustment was made for multiple testing. Given that relatively few of the patients in our study developed glaucoma or were suspected of having glau- SURGICAL TECHNIQUE coma, the statistical power of our study is limited. Patients randomly assigned to the contact lens group under- went a lensectomy and anterior vitrectomy.
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