Purpose: We report endothelial cell (EC) characteristics and central corneal thickness (CCT) from Infant Aphakia treatment Study (IATS) patients at the 5-year exam.
Design: Randomized, controlled trial of the treatment of unilateral cataract with aphakic contact lens (CL) versus primary intraocular lens implant (IOL).
Subjects: 114 infants with unilateral cataract.
Methods: EC density, coefficient of variation (CV), and percent hexagonal cells were measured by non-contact specular microscopy. Central corneal thickness (CCT) was measured using contact pachymetry. Fellow eyes served as controls.
Main outcome measures: Mean differences between treated and fellow eyes of CL and IOL groups were compared with a paired t test. A one-way analysis of variance model and the Tukey-Kramer multiple comparison procedure were used to assess the effect of a diagnosis of glaucoma or glaucoma suspect.
Results: 105 (52 CL, 53 IOL) had either specular microscopy or corneal thickness data recorded. Mean EC densities were higher in the aphakic eyes compared to fellow eyes (3921 and 3495 cells/mm2, p < 0.0001). Mean CV was higher in aphakic eyes (27 vs 24, p=0.0002), and mean percent hexagonal cells was lower (72% vs 76%, p=0.002). Mean CCT of aphakic eyes was higher than controls (637 vs 563 μm, p < 0.0001). There was no difference in EC densisty in eyes treated with IOL compared to fellow eyes (3445 and 3487 cells/mm2, p=0.68). Means for CV (25 vs 24, p=0.07) and percent hexagonal cells (74 vs 76%, p=0.27) were also not significantly different. Mean CCT was higher in eyes with IOL (605 vs 571 μm, p < 0.0001) compared to fellow eyes. Compared to treated eyes without glaucoma or glaucoma suspect, treated eyes with glaucoma had lower EC density (3289 vs 3783 cells/mm2, p = 0.03) and treated eyes with glaucoma suspect had greater mean corneal thickness (660 vs 612 μm, p = 0.0036).
Conclusion: Cataract extraction during infancy with IOL implantation was not associated with a reduced EC count in treated compared to fellow eyes, although CCT was increased. Extended wear aphakic CL may cause corneal polymegathism with increased EC density and CCT. Glaucoma diagnosis was associated with reduced EC counts and increased CCT.
Objective: To evaluate the characteristics of strabismus in infants who underwent cataract surgery with and without intraocular lens (IOL) implantation.
Design: Secondary outcome analysis in a prospective, randomized clinical trial. Participants: The Infant Aphakia Treatment Study is a randomized, multicenter (n = 12), clinical trial comparing treatment of aphakia with a primary IOL or contact lens in 114 infants with a unilateral congenital cataract.
Intervention: Infants underwent cataract surgery with or without placement of an IOL.
Main Outcome Measures: The proportion of patients in whom strabismus developed during the first 12 months of follow-up was calculated using the life-table method and was compared across treatment groups and age strata using a log-rank test.
Results: Strabismus developed within the first 12 months of follow-up in 38 pseudophakic infants (life-table estimate, 66.7%) and 42 infants (life-table estimate, 74.5%) treated with contact lenses (P = 0.59). The younger cohort (<49 days) at the time of surgery demonstrated less strabismus (29 of 50; life-table estimate, 58.0%) than the older cohort (≥49 days; 51 of 64; life-table estimate, 80.0%; P<0.01).
Conclusions: Intraocular lens placement does not prevent the early development of strabismus after congenital cataract surgery. However, strabismus was less likely to develop in infants whose cataract was removed at an earlier age. Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.
Objective: To evaluate the accuracy of detecting clinically significant retinopathy of prematurity (ROP) using wide-angle digital retinal photography. Methods: Literature searches of PubMed and the Cochrane Library databases were conducted last on December 7, 2010, and yielded 414 unique citations. The authors assessed these 414 citations and marked 82 that potentially met the inclusion criteria. These 82 studies were reviewed in full text; 28 studies met inclusion criteria. The authors extracted from these studies information about study design, interventions, outcomes, and study quality. After data abstraction, 18 were excluded for study deficiencies or because they were superseded by a more recent publication. The methodologist reviewed the remaining 10 studies and assigned ratings of evidence quality; 7 studies were rated level I evidence and 3 studies were rated level III evidence. Results: There is level I evidence from < 5 studies demonstrating that digital retinal photography has high accuracy for detection of clinically significant ROP. Level III studies have reported high accuracy, without any detectable complications, from real-world operational programs intended to detect clinically significant ROP through remote site interpretation of wide-angle retinal photographs. Conclusions: Wide-angle digital retinal photography has the potential to complement standard ROP care. It may provide advantages through objective documentation of clinical examination findings, improved recognition of disease progression by comparing previous photographs, and the creation of image libraries for education and research. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references.
Purpose: To evaluate safety and efficacy of difluprednate 0.05% ophthalmic emulsion for treatment of postoperative inflammation after cataract surgery in pediatric patients.
Methods: This was a phase 3B, multicentre, randomized, double-masked, active-controlled study of patients aged 0-3 years who underwent uncomplicated cataract surgery in one eye, with/without intraocular lens implantation. Patients were randomized to receive difluprednate 0.05% four times daily or prednisolone acetate 1% for 14 days post surgery, followed by tapering for 14 days. Safety included evaluation of adverse events. Primary efficacy was the proportion of patients with an anterior cell grade of 0 (no cells) at day 14; secondary efficacy was a global inflammation score.
Results: Forty patients were randomized to each treatment group. Adverse drug reactions included corneal oedema (difluprednate 0.5%, n=1; prednisolone acetate 1%, n=0) and increased intraocular pressure or ocular hypertension (n=2/group). Mean intraocular pressure values during treatment were 2-3 mm Hg higher with difluprednate 0.05% compared with prednisolone acetate 1%; mean values were similar between groups by the first week after treatment cessation. At 2 weeks post surgery, the incidence of complete clearing of anterior chamber cells was similar between groups (difluprednate 0.05%, n=30 (78.9%); prednisolone acetate 1%, n=31 (77.5%). Compared with prednisolone acetate 1%, approximately twice as many difluprednate 0.05%-treated patients had a global inflammation assessment score indicating no inflammation on day 1 (n=12 (30.8%) vs n=7 (17.5%) and day 8 (n=18 (48.7%) vs n=10 (25.0%).
Conclusions: Difluprednate 0.05% four times daily showed safety and efficacy profiles similar to prednisolone acetate 1% four times daily in children 0-3 years undergoing cataract surgery.
We report a case of diffuse bilateral retinal and optic nerve sheath hemorrhages in an 8-week-old boy who was found unresponsive. The child underwent prolonged cardiopulmonary resuscitation and was noted on admission to have a coagulopathy. An autopsy determined the cause of death to be a myocardial infarct in the distribution of an anomalous coronary artery. This case demonstrates the difficulty that may occur in establishing whether child abuse caused death in the setting of another potential cause of mortality.
Purpose: To investigate the role of preoperative biometry for selecting initial contact lens power.
Methods: Patients randomized to receive contact lenses in the Infant Aphakia Treatment Study (IATS) were retrospectively analyzed. Inclusion criteria were availability of both a preoperative immersion axial length measurement and a 1-month postoperative refractive value. The target contact lens power for distance was determined using 1-month postoperative spherical equivalent refraction (after adjusting for a vertex distance) over the known contact lens power. We compared targeted contact lens power for distance with three other treatment techniques: (1) 30 D contact lens (32 D minus 2 D overcorrection for near vision based on IATS protocol); (2) regression-estimated contact lens power of 84.4 - 3.2 × axial length; and (3) IOL power calculated using the Sanders-Retzlaff-Kraff (SRK/T) regression formula with a modified A-constant (112.176). Prediction error (targeted minus estimated contact lens power) and its absolute values were calculated.
Results: A total of 34 eyes of 34 patients met inclusion criteria. Age at the time of cataract surgery was 2.4 ± 1.7 months. Follow-up refraction was performed at 31 ± 3 days after surgery. Target contact lens power for distance was 26.0 ± 4.5 D for the IATS cohort (which excluded infants with corneal diameter <9 mm). The mean prediction error was -4.0, -1.0, and -2.0 D and mean absolute prediction error was 4.4, 2.2, and 2.9 D, respectively, for 30 D contact lens, regression, and SRK/T-estimated power.
Conclusions: Preoperative biometry can be used to estimate contact lens power for distance if an accurate refraction cannot be obtained initially.
METHODS: The Infant Aphakia Treatment Study is a multicenter clinical trial in which 114 infants with unilateral congenital cataracts were randomized to undergo cataract extraction with IOL placement or contact lens aphakic correction. Surgical videos were reviewed with regard to incision type and location, whether the incision was extended, the number of sutures placed, and technique of closure. Corneal astigmatism was measured using a handheld keratometer prior to surgery and at 1 year of age.PURPOSE: To evaluate the effect of surgical factors on postoperative astigmatism in infants undergoing cataract extraction with or without intraocular lens (IOL) implantation.RESULTS: Corneal astigmatism decreased from a mean of 1.92 D at baseline to 1.62 D at age 1 year in the contact lens group but remained almost unchanged from 2.00 D to 2.09 D in the IOL group (P = 0.023). There was no statistical difference between the amount of corneal astigmatism with regard to incision type (P = 0.214) and no increase in astigmatism with extension of the incision to facilitate IOL placement (P = 0.849) at 1 year. The number of sutures and technique of closure did not influence the amount of astigmatism at 1 year.CONCLUSIONS: At the age of 1 year following cataract extraction in infants, contact lens correction and the lack of IOL placement are associated with a significant decrease in postoperative corneal astigmatism compared to IOL placement. No other surgical factors considered in this study had a statistically significant effect on corneal astigmatism.
Purpose: To describe a video-documented assessment of cataract type in the eyes of patients with monocular infantile cataract who were enrolled in the Infant Aphakia Treatment Study.
Methods: The Infant Aphakia Treatment Study is a randomized clinical trial in which the investigators compared intraocular lens (IOL) versus contact lens correction in 114 infants, aged 28 days to <7 months. A total of 83 videos were available for morphological analysis of cataract. Three examiners reviewed all surgical recordings and agreed on the cataract characteristics by using a score sheet to record the lens layer or configuration of the opacity.
Results: Nuclear cataract was present in 45 of 83 eyes (54%). Posterior capsule plaque was observed in 73 eyes (88%). All eyes with fetal nuclear cataract had associated posterior capsule plaque. Cortical cataract without nuclear involvement was seen in 21 eyes (25%). Posterior bowing of the posterior capsule was noted in 4 eyes (5%). Evidence of persistent fetal vasculature (PFV) was present in 18 eyes (22%). PFV was the only finding in 5 eyes but was also seen in combination with nuclear (7 eyes) and cortical cataracts (6 eyes). The entire lens was white in 3 eyes (4%), whereas the lens was partially resorbed in 7 (8%) eyes. Anterior capsule fibrosis was noted in 5 eyes with advanced cataract (1 with total cataract, 4 with partially resorbed lens).
Conclusions: Nuclear opacities were common, but many different cataract types presented in infancy. PFV occurred in isolation or in association with cataract. Posterior capsule plaque was frequently noted, especially when a nuclear cataract was present.
Purpose. To study eye movements in a large group of children after the removal of unilateral infantile cataract, and to compare fixation instabilities between treatment groups with or without IOL implantation. Methods. The Infant Aphakia Treatment Study (IATS) is a randomized, multicenter clinical trial comparing IOL to contact lens (CL) treatment with a unilateral infantile cataract in participants who underwent cataract surgery at 1 to 6 months of age. At age 4.5 years, eye movements were recorded in 103 participants, using a high-speed video camera while the child performed a fixation task. The recordings were inspected by masked readers for the presence of fixation instabilities (nystagmus and saccadic oscillations). Results. Overall, fixation instabilities were observed in 50 (60%) of 83 children who had evaluable recordings, with no differences between treatment groups (27 [64%] of 42 in the IOL group, 23 [56%] of 41 in the CL group; P = 0.51). Nystagmus was seen in 38% and saccadic oscillations in 31%, with no differences between treatment groups (P > 0.33). Children without a fixation instability had better visual acuity (P = 0.04). Conclusions. Nystagmus and saccadic oscillations are well-known consequences of infantile cataracts, presumably the result of visual deprivation during the critical period of visual development. After early cataract extraction, successful optical correction may reduce further form deprivation and minimize the incidence of these fixation instabilities. In this study, no differences in the presence of fixation instabilities were found between the two treatment strategies (CL or IOL) for optical correction after cataract removal. (ClinicalTrials.gov number, NCT00212134.)
To determine whether the fellow eye of children who have undergone unilateral cataract extraction in the first year of life are at increased risk of injury and vision loss, the 10.5-year data on 109 of 114 children enrolled in the Infant Aphakia Treatment Study were examined. Based on this limited data, it was estimated that the fellow eye is at greater risk of injury than the operated eye. Our data do not support the risk being higher in children with the worst vision in the treated eye.[Formula presented]