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

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

Outcomes of Bilateral Cataract Surgery in Infants 7 to 24 Months of Age Using the Toddler Aphakia and Pseudophakia Treatment Study Registry

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

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

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

Subluxation of the crystalline lens: A no-ring approach

Purpose: To report the surgical technique and outcomes of a no-ring approach to posterior chamber intraocular lens (IOL) implantation in children and young adults with subluxation of the crystalline lens. Methods: A three-piece 5.5-mm hydrophobic acrylic IOL was implanted in which the optic and one haptic were inside the capsular bag and the other haptic was in the ciliary sulcus. The implantations were done in 13 eyes of 10 patients with lens subluxation. One haptic was fixated in the ciliary sulcus by passing it through an operculum-shaped opening in the capsular bag edge, made between 2 and 3 clock hours, clockwise from the middle point of the subluxated area. Results: The mean age of the 10 patients was 12.61 ± 8.04 years and the mean follow-up was 21.38 ± 11.29 months. The mean preoperative and postoperative best-corrected visual acuity (BCVA) was 1.15 ± 0.58 and 0.37 ± 0.17 logarithm of the minimum angle of resolution, respectively, in 11 measured eyes. The postoperative BCVA was 20/40 or better in 4 eyes (36.36%), between 20/40 and 20/60 in 6 eyes (54.54%), and between 20/80 and 20/100 in 1 eye (9.09%). The BCVA improved in all eyes. Postoperative IOL decentration between 1.0 and 1.5 mm occurred in 3 of 13 eyes (23.08%). Conclusion: The results indicate that the no-ring technique allows centration of an IOL implanted into a subluxated capsular bag without using capsule tension rings. © SLACK Incorporated