Infant Aphakia Treatment Study (IATS) (IATS)
|Congenital Cataract||Device: hyperopic correction of infant surgical aphakia with Contact Lens Device: primary implantation of aphakic intraocular lens||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Infant Aphakia Treatment Study (IATS)|
- 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.
- 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 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
|Study Start Date:||December 2004|
|Study Completion Date:||November 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Active Comparator: aphakic contact lens
optical correction of infant aphakia with aphakic Contact lens
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: hyperopic correction of infant surgical aphakia with Contact Lens
optical correction of infant surgical aphakia with Contact lens
Experimental: aphakic intraocular lens
optical correction of infant aphakia with aphakic Intraocular Lens
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: primary implantation of aphakic intraocular lens
optical correction of surgical aphakia with intraocular lens
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 perform subjective visual acuity testing at 4.5 years of age and 5 year follow-up vision and ocular health exams on all children.
We will submit a competitive application to be able to have a single visit by the patients in this cohort when they reach 10 years of age. This will be past the amblyogenic period and permit a more accurate comparative assessment of visual acuity and ocular health between the primary intervention groups.
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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00212134
|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||Emory University Eye Center|