Browsing by Author "Wilson, M. Edward"

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    Complications at 10 Years of Follow-up in the Infant Aphakia Treatment Study
    (Elsevier, 2020-11) Plager, David A.; Bothun, Erick D.; Freedman, Sharon F.; Wilson, M. Edward; Lambert, Scott R.; Ophthalmology, School of Medicine
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    Complications in the first 5 years following cataract surgery in infants with and without intraocular lens implantation in the Infant Aphakia Treatment Study
    (Elsevier, 2014-11) Plager, David A.; Lynn, Michael J.; Buckley, Edward G.; Wilson, M. Edward; Lambert, Scott R.; Infant Aphakia Treatment Study Group; Department of Ophthalmology, IU School of Medicine
    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. METHODS: A total of 114 infants were enrolled in the Infant Aphakia Treatment Study, a randomized, multi-center (12) clinical trial comparing the treatment of unilateral aphakia in patients under 7 months of age with a primary IOL implant or contact lens. The rate, character, and severity of intraoperative complications, adverse events, and additional intraocular surgeries during the first 5 postoperative years in the 2 groups were examined. RESULTS: There were more patients with intraoperative complications (28% vs 11%, P = .031), adverse events (81% vs 56%, P = .008), and more additional intraocular surgeries (72% vs 16%, P < .0001) in the IOL group than in the contact lens group. However, the number of patients with adverse events in the contact lens group increased (15 to 24) in postoperative years 2-5 compared to the first postoperative year, while it decreased (44 to 14) in years 2-5 compared to the first postoperative year in the IOL group. If only one half of the patients in the contact lens (aphakic) group eventually undergo secondary IOL implantation, the number of additional intraocular surgeries in the 2 groups will be approximately equal. CONCLUSION: The increased rate of complications, adverse events, and additional intraocular surgeries associated with IOL implantation in infants <7 months of age militates toward leaving babies aphakic if it is considered likely that the family will be successful with contact lens correction.
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    Outcomes of Bilateral Cataract Surgery in Infants 7 to 24 Months of Age Using the Toddler Aphakia and Pseudophakia Treatment Study Registry
    (Elsevier, 2021-02) Bothun, Erick D.; Wilson, M. Edward; Vanderveen, Deborah K.; Plager, David A.; Freedman, Sharon F.; Trivedi, Rupal H.; Traboulsi, Elias I.; Anderson, Jill S.; Loh, Allison R.; Yen, Kimberly G.; Weil, Natalie C.; Morrison, David; Lambert, Scott R.; Ophthalmology, School of Medicine
    Purpose To evaluate outcomes of bilateral cataract surgery in children aged 7 to 24 months and compare rates of adverse events (AEs) with other Toddler Aphakia and Pseudophakia Study (TAPS) registry outcomes. Design Retrospective clinical study at 10 Infant Aphakia Treatment Study (IATS) sites. Statistical analyses comparing this cohort with previously reported TAPS registry cohorts. Participants Children enrolled in the TAPS registry between 2004 and 2010. Methods Children underwent bilateral cataract surgery with or without intraocular lens (IOL) placement at age 7 to 24 months with 5 years of postsurgical follow-up. Main Outcome Measures Visual acuity (VA), occurrence of strabismus, AEs, and reoperations. Results A total of 40 children (76 eyes) who underwent bilateral cataract surgery with primary posterior capsulectomy were identified with a median age at cataract surgery of 11 months (7–23); 68% received a primary IOL. Recurrent visual axis opacification (VAO) occurred in 7.5% and was associated only with the use of an IOL (odds ratio, 6.10; P = 0.005). Glaucoma suspect (GS) was diagnosed in 2.5%, but no child developed glaucoma. In this bilateral cohort, AEs (8/40, 20%), including glaucoma or GS and VAO, and reoperations occurred in a similar proportion to that of the published unilateral TAPS cohort. When analyzed with children aged 1 to 7 months at bilateral surgery, the incidence of AEs and glaucoma or GS correlated strongly with age at surgery (P = 0.011/0.004) and glaucoma correlated with microcornea (P = 0.040) but not with IOL insertion (P = 0.15). Conclusions Follow-up to age 5 years after bilateral cataract surgery in children aged 7 to 24 months reveals a low rate of VAO and very rare glaucoma or GS diagnosis compared with infants with cataracts operated at < 7 months of age despite primary IOL implantation in most children in the group aged 7 to 24 months. The use of an IOL increases the risk of VAO irrespective of age at surgery.
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    Outcomes of Bilateral Cataracts Removed in Infants 1 to 7 Months of Age Using the Toddler Aphakia and Pseudophakia Treatment Study Registry
    (Elsevier, 2020-04) Bothun, Erick D.; Wilson, M. Edward; Vanderveen, Deborah K.; Plager, David A.; Freedman, Sharon F.; Trivedi, Rupal H.; Traboulsi, Elias I.; Anderson, Jill S.; Loh, Allison R.; Yen, Kimberly G.; Weil, Natalie C.; Morrison, David; Lambert, Scott R.; Toddler Aphakia and Pseudophakia Study; Ophthalmology, School of Medicine
    Purpose To evaluate outcomes of bilateral cataract surgery in infants 1 to 7 months of age performed by Infant Aphakia Treatment Study (IATS) investigators during IATS recruitment and to compare them with IATS unilateral outcomes. Design Retrospective case series review at 10 IATS sites. Participants The Toddler Aphakia and Pseudophakia Study (TAPS) is a registry of children treated by surgeons who participated in the IATS. Methods Children underwent bilateral cataract surgery with or without intraocular lens (IOL) placement during IATS enrollment years 2004 through 2010. Main Outcome Measures Visual acuity (VA), strabismus, adverse events (AEs), and reoperations. Results One hundred seventy-eight eyes (96 children) were identified with a median age of 2.5 months (range, 1–7 months) at the time of cataract surgery. Forty-two eyes (24%) received primary IOL implantation. Median VA of the better-seeing eye at final study visit closest to 5 years of age with optotype VA testing was 0.35 logarithm of the minimum angle of resolution (logMAR; optotype equivalent, 20/45; range, 0.00–1.18 logMAR) in both aphakic and pseudophakic children. Corrected VA was excellent (<20/40) in 29% of better-seeing eyes, 15% of worse-seeing eyes. One percent showed poor acuity (≥20/200) in the better-seeing eye, 12% in the worse-seeing eye. Younger age at surgery and smaller (<9.5 mm) corneal diameter at surgery conferred an increased risk for glaucoma or glaucoma suspect designation (younger age: odds ratio [OR], 1.44; P = 0.037; and smaller cornea: OR, 3.95; P = 0.045). Adverse events also were associated with these 2 variables on multivariate analysis (younger age: OR, 1.36; P = 0.023; and smaller cornea: OR, 4.78; P = 0.057). Visual axis opacification was more common in pseudophakic (32%) than aphakic (8%) eyes (P = 0.009). Unplanned intraocular reoperation occurred in 28% of first enrolled eyes (including glaucoma surgery in 10%). Conclusions Visual acuity after bilateral cataract surgery in infants younger than 7 months is good, despite frequent systemic and ocular comorbidities. Although aphakia management did not affect VA outcome or AE incidence, IOL placement increased the risk of visual axis opacification. Adverse events and glaucoma correlated with a younger age at surgery and glaucoma correlated with the presence of microcornea.
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    Reply: To PMID 25077835
    (Elsevier, 2014-12) Plager, David A.; Buckley, Edward G.; Wilson, M. Edward; Lambert, Scott R.; Department of Ophthalmology, IU School of Medicine
    Complications in the first 5 years following cataract surgery in infants with and without intraocular lens implantation in the Infant Aphakia Treatment Study. [Am J Ophthalmol. 2014] Complications in the first 5 years following cataract surgery in infants with and without intraocular lens implantation in the infant aphakia treatment study. [Am J Ophthalmol. 2014]
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    Safety and efficacy data supporting U.S. FDA approval of intracameral phenylephrine and ketorolac 1.0%/0.3% for pediatric cataract surgery: clinical safety and pupil and pain management
    (Wolters Kluwer, 2020-06) Wilson, M. Edward; Trivedi, Rupal H.; Plager, David A.; Ophthalmology, School of Medicine
    Purpose: To assess the safety of phenylephrine and ketorolac (PE/K) 1.0%/0.3% compared with phenylephrine (PE) 1.0% in children aged 0 to 3 years undergoing cataract surgery. The effect of PE/K to PE on intraoperative pupil diameter and postoperative pain were also compared. Setting: Multicenter study in the United States. Design: Randomized double-masked phase 3 clinical trial. Methods: This study was powered to assess safety only. Depending on randomization, 4 mL of PE/K 1.0%/0.3% or PE 1.0% was injected into the surgical irrigation solution. Safety endpoints were assessed up to 90 days postoperatively. From surgical videos, a masked central reader measured the change in pupil diameter from immediately prior to incision to wound closure. Postoperative pain was measured using Alder Hey Triage Pain Score at 3 hours, 6 hours, 9 hours, and 24 hours following wound closure and recorded by parent/caregiver. Results: Seventy-two patients received masked intervention. There were no notable changes in vital signs or ophthalmological complications in either group. Mean change in pupil diameter was similar between PE/K 1.0%/0.3% and PE 1.0% (mean difference in area under the curve −0.071; P = .599). Postoperative ocular pain scores and overall mean scores were lower in PE/K group at all individual time points, and differences in overall mean scores were statistically significant at 6 and 24 hours (P = .029 and 0.021, respectively). Conclusions: PE/K 1.0%/0.3% was safe for use in children and maintained mydriasis during cataract surgery. Postoperative pain levels were lower in the PE/K 1.0%/0.3% group.