Working… Menu

Infant Aphakia Treatment Study (IATS) (IATS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00212134
Recruitment Status : Active, not recruiting
First Posted : September 21, 2005
Results First Posted : January 5, 2015
Last Update Posted : April 8, 2021
National Eye Institute (NEI)
Alcon Research
Bausch & Lomb Incorporated
Eye Care and Cure
Information provided by (Responsible Party):
Scott Reed Lambert, Stanford University

Brief Summary:
The primary purpose is to determine whether infants with a unilateral congenital cataract are more likely to develop better vision following cataract extraction surgery if they undergo primary implantation of an intraocular lens or if they are treated primarily with a contact lens. In addition, the study will compare the occurrence of postoperative complications and the degree of parental stress between the two treatments.

Condition or disease Intervention/treatment Phase
Congenital Cataract Device: Contact lens correction of aphakia Device: Intraocular lens implantation Not Applicable

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
Official Title: Infant Aphakia Treatment Study (IATS)
Study Start Date : December 2004
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Eye Wear

Arm Intervention/treatment
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
Other Names:
  • Silsoft aphakic contact lens
  • rigid gas permeable 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
Other Names:
  • Alcon SA60AT
  • Alcon MA60AC

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

Secondary Outcome Measures :
  1. 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

  2. Percent of Patients With 1 or More Adverse Events [ Time Frame: Study enrollment to age 5 years ]
  3. 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.

  4. 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.

  5. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   up to 210 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Visually significant unilateral congenital cataract (central opacity equal to or greater than 3 mm in size).
  • Cataract surgery performed when the patient is 28 to 210 days of age and at least 41 post-conceptional weeks.

Exclusion Criteria:

  • The cataract is known to be acquired from trauma or as a side-effect of a treatment administered postnatally such as radiation or medical therapy.
  • A corneal diameter less than 9 mm measured in the horizontal meridian using calipers.
  • An intraocular pressure of 25 mm Hg or greater in the affected eye measured with a Perkins tonometer, tonopen, or pneumatonometer.
  • Persistent fetal vasculature (PFV) causing stretching of the ciliary processes or a tractional retinal detachment.
  • Active uveitis or signs suggestive of a previous episode of uveitis such as posterior synechiae or keratic precipitates.
  • The child is the product of a pre-term pregnancy (<36 gestational weeks). Screening for prematurity will be based on the clinician's best assessment of gestational age. If a physician is uncertain regarding the gestational age, review of medical records or contact with the pediatrician and/or obstetrician should be used to confirm gestational age at delivery. Unless a clinician is uncertain as to whether a child was born at less than 36 weeks or not, confirmation of gestational age via medical record review may be delayed until after enrollment.
  • Retinal disease that may limit the visual potential of the eye such as retinopathy of prematurity.
  • Previous intraocular surgery.
  • Optic nerve disease that may limit the visual potential of the eye such as optic nerve hypoplasia.
  • The fellow eye has ocular disease that might reduce its visual potential.
  • The child has a medical condition known to limit the ability to obtain visual acuity at 12 months or 4 years of age.
  • Refusal by the Parent/Legal Guardian to sign an informed consent or to be randomized to one of the two treatment groups.
  • Follow-up of the child is not feasible because the child would not be able to return for regular follow-up examinations and the outcome assessments (e.g. transportation difficulties, relocation, etc.).

Information from the National Library of Medicine

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 identifier (NCT number): NCT00212134

Layout table for location information
United States, California
Stanford University
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
Harvard University
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
Vanderbilt University
Nashville, Tennessee, United States, 37232-8808
United States, Texas
Pediatric Ophthalmology, P.A.
Dallas, Texas, United States, 75225
Baylor University
Houston, Texas, United States, 77030
Sponsors and Collaborators
Stanford University
National Eye Institute (NEI)
Alcon Research
Bausch & Lomb Incorporated
Eye Care and Cure
Layout table for investigator information
Study Chair: Scott Lambert, MD Stanford University
  Study Documents (Full-Text)

Documents provided by Scott Reed Lambert, Stanford University:
Additional Information:

Publications automatically indexed to this study by Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Scott Reed Lambert, Professor, Stanford University Identifier: NCT00212134    
Other Study ID Numbers: IRB00024837
U10EY013272 ( U.S. NIH Grant/Contract )
EY013287 ( Other Grant/Funding Number: Emory )
EY013272 ( Other Grant/Funding Number: Emory )
NEI-108 ( Other Identifier: Other )
First Posted: September 21, 2005    Key Record Dates
Results First Posted: January 5, 2015
Last Update Posted: April 8, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Scott Reed Lambert, Stanford University:
cataract surgery
intraocular lens
contact lens
Additional relevant MeSH terms:
Layout table for MeSH terms
Lens Diseases
Eye Diseases
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs