The role of preoperative biometry in selecting initial. According to the american association for pediatric ophthalmology and strabismus, both surgical and optical treatment must be provided urgently for childhood cataracts. The intentiontotreat strategy is used in randomized clinical trials to ensure that treatment groups remain similar. A secondary analysis of a randomized clinical trial. 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. The role of preoperative biometry in selecting initial contact lens power in the infant aphakia treatment study rupal h. We feel that as not all the study participants met the outcome criteria, this study does not fit the definitionofanintentiontotreatstudy,whichshouldincludeallthe. This twoday event features clinical and scientific lectures led by faculty, alumni presentations, a trainee poster contest, and much more.
The optical correction of aphakia in children has changed dramatically however, accurate optical rehabilitation and postoperative supervision in pediatric cases is more difficult than adults. A randomized, multicenter, double masked, parallelgroup study assessing the safety and efficacy of loteprednol etabonate ophthalmic gel, 0. The infant aphakia treatment study iats is a randomized, controlled. Pdf parenting stress in the infant aphakia treatment study. Complications in the first 5 years following cataract surgery in infants with and without intraocular lens implantation in the infant aphakia treatment study. Treatment for aphakia in children and infants is very important. We feel that as not all the study participants met the outcome criteria, this study does not fit the defini tionofanintentiontotreatstudy,whichshouldincludeallthe.
Lessons learned about cataract surgery from the infant aphakia. Jul 16, 2014 to describe the incidence of unilateral congenital cataract associated with minimal ultrasonically undetectable levels of persistent fetal vasculature in the first 18 months of the life and to report surgical methods for intraocular lens implantation, using 25gauge vitrectomy system. Parenting stress and adherence to occlusion therapy in the. Partnering with the pediatric ophthalmology service. Children under seven months of age, with a cataract in only one eye, are randomized in either an iol group or a contact lens group. A randomized clinical trial comparing contact lens to intraocular lens correction of monocular aphakia during infancy. The infant aphakia treatment study iats is a randomized, multicenter clinical trial comparing treatment of aphakia with a primary iol or contact lens in 114 infants with a unilateral.
Complications in the first 5 years following cataract. The optimal optical treatment of aphakia in infants is unknown. Corneal changes in children after unilateral cataract surgery in the infant aphakia treatment study david g morrison1, michael j lynn2, sharon f freedman3, faruk h orge4, scott r lambert5, and the infant aphakia treatment study group 1 department of ophthalmology and visual sciences, vanderbilt university, nashville, tn 2 department of biostatistics and bioinformatics, emory university. Many studies confirm the reliability and validity of the total stress score abidin, 1995. Infants enrolled in the infant aphakia treatment study iats. Incidence and risk factors of earlyonset glaucoma following. The infant aphakia treatment study iats is a multicenter, randomized clinical trial comparing cataract surgery with or without iol implantation in infants aged 1 to 6 months with a unilateral congenital cataract. Intraocular lens implantation in unilateral congenital. Vandierbsilt ion vanderbilt university medical center. To the editor we read with interest the article on 4. Infant aphakia treatment study stu 052011151 july 22, 2011 emorynih national eye institute principal investigator. Practical value of the study and implementation of the study results. The treatments being studied are use of a contact lens.
Sep 21, 2005 infant aphakia treatment study iats iats the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The prevalence of cataract in children has been estimated between 11510,000 children 3. Pdf the infant aphakia treatment study design and clinical. Each trial is presented in a uniform manner, detailing the background and purpose of the study, design, number of subjects with inclusion and exclusion criteria, outcomes, then results and conclusions. Study protocol and statistical analysis plan pdf april 29, 2015. Assessment of adherence to visual correction and occlusion therapy in the infant aphakia treatment study article pdf available may 2016 with 67 reads how we measure reads. The infant aphakia treatment study iats is a randomized, multicenter clinical trial comparing treatment of aphakia with a primary iol or contact lens in 114 infants with a unilateral congenital cataract. Edward wilson, md, a and for the infant aphakia treatment study group. Mar 07, 2014 the international council of ophthalmology ico represents and serves professional associations of ophthalmologists throughout the world. Diagnosis of glaucoma was made when the iop was 21 mm hg with one or more of following progressive optic disk cupping, increase in horizontal corneal diameter, increased myopic shift, and the use of surgery to control iop. After the cataracts are removed, the parents have to. We report endothelial cell ec characteristics and central corneal thickness cct from infant aphakia treatment study iats patients at the 5year exam.
Outcomes in the infant aphakia treatment study hall g pediatric deborah k vanderveen md, coauthor po248 scientific poster 12. In addition, he joined the faculty at the vision care institute, llc in 2006 and given emeritus status in 2012. Drewsbotsch c, celano m, cotsonis g, hartmann ee, lambert sr. Infant aphakia treatment study iats full text view. To share knowledge gained from the infant aphakia treatment study on the. The infant aphakia treatment study iats is a multicenter randomized clinical trial comparing intraocular. Comparison of the rate of refractive growth in aphakic. To report the myopic shift at 5 years of age after cataract surgery with intraocular lens iol implantation for infants enrolled in the infant aphakia treatment study iats. The infant aphakia treatment study iats is a multicenter, randomized. The infant aphakia treatment study iats was designed to compare visual outcomes in children who were aged 1 to 6 months at the time of unilateral congenital cataract surgery and were randomized to either optical correction with contact lenses or intraocular lenses. References and suggested readings plager da, lynn mj, buckley eg, et al. Oneyear strabismus outcomes in the infant aphakia treatment. The infant aphakia treatment study iats was supported through a cooperative agreement with the united states national eye institute of the national institutes of health and performed at 12 clinical sites.
The infant aphakia treatment study iats is a multicenter randomized clinical trial comparing intraocular lens and contact lens correction for monocular aphakia. Lambert has been chairman of the infant aphakia treatment study since 2004. Patients with a unilateral cataract due to persistent fetal vasculature pfv were allowed in our study as long as the pfv. Predictability of intraocular lens power calculation. The infant aphakia treatment study iats is studying outcomes in children with 116 unilateral cataract randomized to either iol or contact lens in the first year of life, after 4. Visual correction and occlusion therapy in the infant aphakia treatment studycontemporary clinical trials communications 3 2016. To assess motor functioning in children aged 4 years 6 months enrolled in the infant aphakia treatment study, and to determine contributions of visual acuity and stereopsis to measured motor skills. Congenital cataract a concise guide to diagnosis and. Complications, adverse events, and additional intraocular. To determine whether infants with a unilateral congenital cataract are more likely to develop.
Celano m, cotsonis ga, hartmann ee, drewsbotsch c, for the infant aphakia treatment study group. The infant aphakia treatment study iats is a multicenter, randomized, controlled clinical trial comparing iol versus contact lens treatment after cataract surgery performed in children with a unilateral congenital cataract between 1 and 6 months of age. Complications, adverse events, and additional intraocular surgery 1 year after cataract surgery in the infant aphakia treatment study. Lambert, md, is a professor of ophthalmology at stanford university school of medicine and pediatric ophthalmology service chief at lucile packard childrens hospital. Recent results of iats infant aphakia treatment study have reported good compliance with contact lens wear in infants and. A randomized clinical trial comparing contact lens with intraocular lens correction of monocular aphakia during infancy.
The infant aphakia treatment study iats is a randomized, controlled multicenter clinical trial with the following objectives. The infant aphakia treatment study iats evaluates the efficacy of iol placement versus aphakia in the treatment of unilateral, congenital cataracts. Since 1988 he has been director of pediatric ophthalmology at the emory eye clinic and chief of ophthalmology, childrens healthcare of atlanta at egleston. We adopted the criteria of infant aphakia treatment study iats10 for diagnosis of glaucoma. Motor skills of children with unilateral visual impairment in. Results from the infant aphakia treatment study, american journal of ophthalmology on deepdyve, the largest online rental service for scholarly research with thousands of academic publications available at your fingertips. Association between occlusion therapy and optotype visual acuity in children using data from the infant aphakia treatment study. Predictability of iol calculation and early refractive. The infant aphakia treatment study iats is a randomized, multicenter trial that compares visual outcomes and adverse events after the treatment of aphakia caused by unilateral congenital cataract extraction with primary intraocular lens iol implantation versus contact lens cl. Strabismus surgery outcomes in the infant aphakia treatment. Conclusions this analysis concurs with previous studies that early surgery is important for good visual outcomes in patients with unilateral infantile cataracts. See publication for full list of the aphakia treatment study group. Refractions were performed at 1 month and every 3 months postoperatively until age 4 years and then. The infant aphakia treatment study was designed to compare the effectiveness and problems associated with optical rehabilitation using contact lenses versus iols for the correction of aphakia in.
The infant aphakia treatment study iats is a multicenter, randomized, controlled clinical trial comparing iol and contact lens treatments after cataract surgery performed in children with a unilateral congenital cataract at 1 to 6 months of age. Number of patients demonstrating stereopsis by age at surgery and visual acuity at 4. Study design the main inclusion criteria were a visually significant congenitalcataract 3mmcentralopacityin1eyeandanagerange of 28 days to less than 210 days at the time of cataract surgery. A total of 114 infants were enrolled in the infant aphakia treatment study, a randomized, multicenter 12 clinical trial comparing the treatment of unilateral aphakia in patients under 7 months of age with a primaryiolimplantorcontactlens.
Read predictability of intraocular lens power calculation formulae in infantile eyes with unilateral congenital cataract. This is a pdf file of an unedited manuscript that has been accepted for. Infant aphakia treatment study group, lambert sr, buckley eg, drewsbotsch c, et al. Aphakia is a condition that involves not having an eye lens. Contact lens vs iol correction of monocular aphakia jama. The visual prognosis may vary according to the morphological type. There were 114 children enrolled in the study with 57 randomized to each treatment group. The lens of your eye is a clear, flexible structure that allows your eye to focus. The authors state that the study follows the intentiontotreat principle.
Infant aphakia treatment study iats iats the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Jul 20, 2017 this handbook is a compilation of major clinical trials in different subspecialties in the field of ophthalmology. The infant aphakia treatment study iats is a randomized, multicenter clinical trial comparing iol to contact lens cl treatment in 114 infants with a. His current areas of research include monocular pediatric aphakia and ocular surface disorders.
Conclusions the optimal optical treatment of aphakia in infants is unknown. Corneal changes in children after unilateral cataract surgery. Pdf assessment of adherence to visual correction and. With publication of its 5year results, the infant aphakia treatment study iats helped illuminate the way forward for these children. Contact lenses and eyeglasses medical clinical policy. This report is a secondary outcome analysis of ocular motor data from iats patients who underwent strabismus surgery prior to age 5 years.
The infant aphakia treatment study group authors and their affiliations are listed on page 26. Randomized, controlled trial of the treatment of unilateral cataract with aphakic contact lens. Infants underwent cataract surgery with or without placement of an iol. Therate,character, and severity of intraoperative complications, adverse. Globe axial length growth at age 5 years in the infant. Myopic shift 5 years after intraocular lens implantation. Infants 28 to 210 days of age with a visually significant cataract in one eye are eligible. Welcome dear friends, welcome to the 2017 harvard medical school department of ophthalmology annual meeting and alumni reunionone of our most exciting and important events of the year.
Michael lynn had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Pdf the infant aphakia treatment study contact lens experience. Pdf to compare the use of contact lenses and intraocular lenses iols for the optical correction of unilateral aphakia during infancy. For the first time the study of a visually significant inborn cataract was undertaken in latvia. National contact lens coordinator for the infant aphakia treatment study.
Rich working filesstudy clubmeetings 8program 8 program 2. Handbook of clinical trials in ophthalmology ebook pdf. Listing a study does not mean it has been evaluated by the u. Contact lenses cl for treatment of paediatric aphakia especially post congenital cataract cases has been in vogue since 1970s with upto 50% patients achieving visual acuity better than 660 1. The infant aphakia treatment study iats is a clinical study designed to determine which treatment for aphakia is better for infants between the ages of 4 weeks to 7 months who were born with a cataract in one eye.
Thus, we felt it important to understand the relationship between parenting stress and adherence to patching in this population of young children. The infant aphakia treatment study iats is a multicenter, randomized, clinical trial sponsored by the national eye institute. Methods refractions were performed at 1 month and every 3 months postoperatively until age 4 years and then at ages 4. The presentations will consist of short didactic lectures, panel. The chop principal investigator for this study, william anninger, md, is actively enrolling patients for the trial. Baseline characteristics of the infant aphakia treatment study. Pdf we describe our experience correcting a cohort of infants with contact lenses in the infant aphakia treatment study. Infant aphakia treatment study group performed a randomized, multicenter 12 sites clinical trial in infants with unilateral congenital cataract, assigned to undergo cataract surgery between 1 and 6 months of age, either with or without primary iol implantation. Corneal changes in children after unilateral cataract. Motor skills of children with unilateral visual impairment in the infant aphakia treatment study marianne celano, phd, abpp1, e.
Documents provided by scott reed lambert, stanford university. Spectacle adherence among fouryearold children in the. The treatments being studied are use of a contact lens cl after surgery or surgically. However, the infant aphakia treatment study was designed to provide empirical evidence of whether optical treatment with an iol or a contact lens after unilateral cataract surgery during infancy is associated with a better visual outcome. 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 infants with and without intraocular lens implantation in the infant aphakia treatment study. The infant aphakia treatment study iats is a multicenter, randomized clinical trial comparing the use of primary iol implantation with the correction of aphakia with a contact lens cl after cataract surgery performed in infants with a unilateral congenital cataract between 1 and 6 months of age. Contact lens adherence in the infant aphakia treatment study. A study of normal peripheral findings hall g retina, vitreous jeremy wolfe phd, coauthor po259 scientific poster 12. To describe a videodocumented assessment of cataract type in the eyes of patients with monocular infantile cataract who were enrolled in the infant aphakia treatment study.
One patient in our study was randomized to the iol group but did not undergo iol implantation, and 3 patients in the contact. Methods the al at baseline and age 5 years and change in al were analyzed relative to treated versus fellow eye, visual outcome, and treatment modality contact lens cl vs. Pediatric aphakia and where to place an intraocular lens. Dubois, med, mmsc, co, comt1, and carolyn drewsbotsch, phd, mph3 on behalf of the infant aphakia treatment study group 1emory university school of medicine, atlanta, ga. Parenting stress in the infant aphakia treatment study journal of. Infant aphakia treatment study group, lambert sr, buckley eg, drewsbotsch c, dubois l, hartmann e, lynn mj, plager da, wilson me. Behaviors of children with unilateral vision impairment in the infant aphakia treatment study. Corneal changes in children after unilateral cataract surgery in the infant aphakia treatment study david g morrison1, michael j lynn2, sharon f freedman3, faruk h orge4, scott r lambert5, and the infant aphakia treatment study group 1 department of ophthalmology and visual sciences, vanderbilt university, nashville, tn.
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