Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Infant Aphakia Treatment Study (IATS)

This study has been completed.
Sponsor:
Collaborators:
Alcon Research
Bausch & Lomb Incorporated
BSN-JOBST Inc.
Eye Care and Cure
Information provided by (Responsible Party):
Scott R Lambert, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00212134
First received: September 13, 2005
Last updated: February 6, 2015
Last verified: February 2015

September 13, 2005
February 6, 2015
December 2004
November 2013   (final data collection date for primary outcome measure)
  • Visual Acuity [ Time Frame: Phase 1 - Age 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Complete list of historical versions of study NCT00212134 on ClinicalTrials.gov Archive Site
  • Percent of Patients With 1 or More Intraoperative Complications at Cataract Surgery [ Time Frame: Cataract surgery immediately after enrollment ] [ Designated as safety issue: Yes ]
  • Percent of Patients With 1 or More Adverse Events [ Time Frame: Study enrollment to age 5 years ] [ Designated as safety issue: Yes ]
  • Parenting Stress [ Time Frame: Phase 1 - 3 months post surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
  • Complications
  • Parenting Stress
Not Provided
Not Provided
 
Infant Aphakia Treatment Study (IATS)
Infant Aphakia Treatment Study (IATS)

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Congenital Cataract
  • Device: hyperopic correction of infant surgical aphakia with Contact Lens
    optical correction of infant surgical aphakia with Contact lens
    Other Names:
    • Silsoft aphakic contact lens
    • rigid gas permeable contact lens
  • Device: primary implantation of aphakic intraocular lens
    optical correction of surgical aphakia with intraocular lens
    Other Names:
    • Alcon SA60AT
    • Alcon MA60AC
  • 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.

    Intervention: Device: hyperopic 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.

    Intervention: Device: primary implantation of aphakic intraocular lens

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
114
November 2013
November 2013   (final data collection date for primary outcome measure)

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.).
Both
up to 210 Days
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00212134
IRB00024837, U10EY013272, EY013287, EY013272, NEI-108
Yes
Scott R Lambert, MD, Emory University
Emory University
  • National Eye Institute (NEI)
  • Alcon Research
  • Bausch & Lomb Incorporated
  • BSN-JOBST Inc.
  • Eye Care and Cure
Study Chair: Scott Lambert, MD Emory University Eye Center
Emory University
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP