Infant Aphakia Treatment Study (IATS) (IATS)

June 9, 2022 updated by: Scott Reed Lambert, Stanford University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94303
        • Stanford University
    • Florida
      • Miami, Florida, United States, 33155
        • Miami Children's Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Eye Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5175
        • Indiana University Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Harvard University
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455-0501
        • University of Minnesota
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Eye Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Oregon
      • Portland, Oregon, United States, 97239-4197
        • Oregon Health and Science University
    • South Carolina
      • Charleston, South Carolina, United States, 29425-2236
        • Medical University of South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37232-8808
        • Vanderbilt University
    • Texas
      • Dallas, Texas, United States, 75225
        • Pediatric Ophthalmology, P.A.
      • Houston, Texas, United States, 77030
        • Baylor University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 9 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Phase 1 - Age 12 months
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.
Phase 2 - Age 4.5 Years
Visual Acuity - Subjective Assessment at Age 10 Years.
Time Frame: Phase 3 - Age 10.5 Years
Visual acuity estimates were standardized by using the Electronic Visual Acuity Tester (EVAT) at each clinical site. The IATS patients were tested at 10.5 years of age allowing the use of the electronic early treatment diabetic retinopathy study (E-ETDRS) testing protocol. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision).
Phase 3 - Age 10.5 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Cataract surgery immediately after enrollment
Percent of Patients With 1 or More Adverse Events
Time Frame: Study enrollment to age 5 years
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.
Phase 1 - 3 months post surgery
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.
Phase 1 - 12 months follow-up
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
Phase 1 - Age 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Eye Institute (NEI)
Bausch & Lomb Incorporated
Alcon Research
BSN-JOBST Inc.
Eye Care and Cure

Investigators

  • Study Chair: Scott Lambert, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2004

Primary Completion (Actual)

August 31, 2020

Study Completion (Actual)

August 31, 2020

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Actual)

July 7, 2022

Last Update Submitted That Met QC Criteria

June 9, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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