Infant Aphakia Treatment Study (IATS) (IATS)
|ClinicalTrials.gov Identifier: NCT00212134|
Recruitment Status : Active, not recruiting
First Posted : September 21, 2005
Results First Posted : January 5, 2015
Last Update Posted : March 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Congenital Cataract||Device: Contact lens correction of aphakia Device: Intraocular lens implantation||Not Applicable|
Intraocular lenses are now a commonly accepted treatment for cataracts in older children and are used increasingly in younger children and infants. Intraocular lenses are superior to contact lenses in that they more closely replicate the optics of the crystalline lens, do not require daily ongoing care, and ensure at least a partial optical correction at all times. The simplicity and improved visual outcome of an intraocular lens correction may make caring for a child with a unilateral congenital cataract less stressful for parents. However, contact lenses remain the accepted treatment for children under 1 year of age due to concerns about the long-term safety of intraocular lenses and the potential for a large myopic shift developing in these eyes as they grow. Contact lenses provide excellent visual results in infants treated for bilateral congenital cataracts; however, two-thirds of infants treated with contact lenses for unilateral congenital cataracts remain legally blind in their aphakic eye. These poor visual outcomes are usually ascribed to competition from the sound eye and poor compliance with patching and contact lens wear regimens. Data from our pilot study and the literature suggest that superior visual results can be obtained if an intraocular lens is used to correct unilateral aphakia during infancy, but these eyes will experience more complications. Intraocular lenses will be increasingly implanted in infants regardless of whether or not we perform this trial. By performing this clinical trial, we can determine if the higher rate of complications with intraocular lenses is offset by improved visual outcome and decreased parenting stress.
The Infant Aphakia Treatment Study (IATS) is a multi-center randomized clinical trial comparing intraocular lens and contact lens correction for monocular aphakia. Infants will be enrolled over a 4 year period. Infants 28 to 210 days of age with a visually significant cataract in one eye are eligible. Cataract surgery will be performed in a standardized fashion by a surgeon who has been certified for the study. Surgery consists of a lensectomy, posterior capsulotomy, and anterior vitrectomy. Infants will be randomized at the time of surgery to one of two treatment groups. Infants randomized to the intraocular lens group will have an intraocular lens implanted into the capsular bag. Spectacles will subsequently be used to correct the residual refractive errors. Infants randomized to the contact lens group will be fitted with a contact lens immediately after surgery. Both groups will receive the same patching therapy and follow-up. All children will be examined by Investigators at fixed intervals using standard protocols with the major endpoint assessed at age 12 months by a Traveling Vision Examiner.
We are currently in a continuation of this project (beyond 5 years) in order to assess which of these patients have glaucoma or glaucoma suspect at age 10.5 years. Our goal is to understand which type of initial optical correction, an IOL or a CL, results in the best long-term visual outcome following unilateral congenital cataract surgery during infancy. Our central hypothesis is that primary IOL implantation will result in a better visual outcome. The rationale for this proposal is that final visual acuity cannot be determined by 5 years of age and the recommendation for early treatment can only be substantiated by adequate long-term assessment in this unique cohort. We chose a follow-up to age 10.5 years because it will provide a more accurate assessment of visual acuity and will allow us to diagnosis most cases of glaucoma.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||114 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Phase 3 is 10.5-year follow-up study since Phase 1. There is no intervention.|
|Masking:||None (Open Label)|
|Official Title:||Infant Aphakia Treatment Study (IATS)|
|Study Start Date :||December 2004|
|Estimated Primary Completion Date :||March 21, 2019|
|Estimated Study Completion Date :||August 31, 2019|
Active Comparator: aphakic contact lens
Contact lens correction of aphakia
INTERVENTION: use of an external contact lens (CL) to correct the large hyperopic refractive error produced by surgically extracting the natural cataractous lens. As the eye grows, the refractive error changes and the power of the CL can be changed accordingly.
Device: Contact lens correction of aphakia
optical correction of infant surgical aphakia with Contact lens
Experimental: aphakic intraocular lens
Intraocular lens implantation
INTERVENTION: At the time of surgery to remove the cataractous natural lens, an intraocular lens was implanted to correct the large hyperopic refractive error induced by the cataract surgery.
Device: Intraocular lens implantation
optical correction of surgical aphakia with intraocular lens
- Visual Acuity [ Time Frame: Phase 1 - Age 12 months ]Visual acuity was measured by standard objective testing procedures at 12 months of age. Monocular grating acuity was assessed by the traveling examiner with the Teller Acuity Cards. This test uses cards with black-on-white lines of varying widths and a set distance apart in a square with fixed dimensions, so the thinner the lines, the more there will be on any given card (cycles/cm). The ability to see thinner lines indicates better vision. The cards with lines are presented simultaneously with a gray card and the child's visual attention is noted. It is presumed that the child will preferentially look at the card with the stripes as it is more interesting. When the lines are too thin and close together so as to be indistinguishable from the gray card, no preferential looking will be noted. The card with the thinnest lines that the child will look at is recorded as the best visual acuity in logMAR units.
- Visual Acuity - Subjective Assessment at Age 4.5 Years. [ Time Frame: Phase 2 - Age 4.5 Years ]Visual acuity estimates were standardized by using the Electronic Visual Acuity Tester (EVAT) at each clinical site. The IATS patients were tested at 4.5 years of age allowing the use of the HOTV recognition acuity test. The Amblyopia Treatment Study protocol for presentation and determination of best corrected visual acuity was followed. Monocular visual acuity was evaluated using single letter optotypes with surround bars presented on the EVAT. The staircase procedure of the ATS projects was followed as this has documented success and reliability with this age group. In order to familiarize the subjects with the HOTV matching test, this test was introduced at the 4.0 year visit and the 4.25 year visit by experienced site personnel.
- Visual Acuity - Subjective Assessment at Age 10 Years. [ Time Frame: Phase 3 Age 10 Years ]Visual acuity assessment using the E-ETDRS protocol will be performed by certified site personnel; patients should be in their best optical correction as determined by the PI either recently or just before the EVA test
- Percent of Patients With 1 or More Intraoperative Complications at Cataract Surgery [ Time Frame: Cataract surgery immediately after enrollment ]Percent of Patients with 1 or More Intraoperative Complications at Cataract Surgery
- Percent of Patients With 1 or More Adverse Events [ Time Frame: Study enrollment to age 5 years ]
- Parenting Stress [ Time Frame: Phase 1 - 3 months post surgery ]The PSI is a 120-item validated self-report measure of parenting stress. PSI is a continuous scale measuring stress with a range of 131 (low stress) to 320 (high stress); the average person's stress scores are between 188 and 252.
- Adherence to Occlusion Therapy [ Time Frame: Phase 1 - 12 months follow-up ]Parental report of the number of hours children wore an patch to occlude the fellow eye.
- Parenting Stress [ Time Frame: Phase 1 - Age 12 Months ]The PSI is a 120-item validated self-report measure of parenting stress. PSI is a continuous scale measuring stress with a range of 131 (low stress) to 320 (high stress); the average person's stress scores are between 188 and 252
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00212134
|United States, California|
|Palo Alto, California, United States, 94303|
|United States, Florida|
|Miami Children's Hospital|
|Miami, Florida, United States, 33155|
|United States, Georgia|
|Emory Eye Center|
|Atlanta, Georgia, United States, 30322|
|United States, Indiana|
|Indiana University Medical Center|
|Indianapolis, Indiana, United States, 46202-5175|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02115|
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455-0501|
|United States, North Carolina|
|Duke University Eye Center|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|United States, Oregon|
|Oregon Health and Science University|
|Portland, Oregon, United States, 97239-4197|
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425-2236|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232-8808|
|United States, Texas|
|Pediatric Ophthalmology, P.A.|
|Dallas, Texas, United States, 75225|
|Houston, Texas, United States, 77030|
|Study Chair:||Scott Lambert, MD||Stanford University|