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
Results First Received: July 15, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Congenital Cataract
Interventions: Device: hyperopic correction of infant surgical aphakia with Contact Lens
Device: primary implantation of aphakic intraocular lens

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment 12/23/04 to 01/16/09 at 12 medical clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Final eligibility determined at pre-operative ocular examination under anesthesia.

Reporting Groups
  Description
Aphakic Contact Lens

optical correction of infant aphakia with aphakic Contact lens

INTERVENTION: aphakic contact lens

Aphakic Intraocular Lens

optical correction of infant aphakia with aphakic Intraocular Lens

INTERVENTION: aphakic intraocular lens


Participant Flow for 2 periods

Period 1:   Phase 1 (to Age 1 Year)
    Aphakic Contact Lens     Aphakic Intraocular Lens  
STARTED     57     57  
Complete First Endpoint at 1 Year     57     57  
COMPLETED     57 [1]   57 [1]
NOT COMPLETED     0     0  
[1] Age 1 data collection visit

Period 2:   Phase 2 (Age 1 Year to Age 5 Years)
    Aphakic Contact Lens     Aphakic Intraocular Lens  
STARTED     57 [1]   57 [1]
COMPLETED     57     56 [2]
NOT COMPLETED     0     1  
[1] Visual acuity assessment at Age 4.5 Years and final visit at Age 5 Years.
[2] Patient lost to follow-up.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Aphakic Contact Lens

optical correction of infant aphakia with aphakic Contact lens

INTERVENTION: aphakic contact lens

Aphakic Intraocular Lens

optical correction of infant aphakia with aphakic Intraocular Lens

INTERVENTION: aphakic intraocular lens

Total Total of all reporting groups

Baseline Measures
    Aphakic Contact Lens     Aphakic Intraocular Lens     Total  
Number of Participants  
[units: participants]
  57     57     114  
Age  
[units: months]
Mean (Standard Deviation)
     
mean/sd     2.4  (1.6)     2.5  (1.6)     2.5  (1.6)  
Age, Customized  
[units: participants]
     
28 - 48 days     25     25     50  
49 days - 3.0 months     17     15     32  
3.1 - 5.0 months     9     10     19  
5.1 - 6.8 months     6     7     13  
Gender  
[units: participants]
     
Female     32     28     60  
Male     25     29     54  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     9     10     19  
Not Hispanic or Latino     48     47     95  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     1     0     1  
Asian     2     1     3  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     3     5     8  
White     49     48     97  
More than one race     0     3     3  
Unknown or Not Reported     2     0     2  
Region of Enrollment  
[units: participants]
     
United States     57     57     114  
Private Insurance  
[units: participants]
     
No     20     24     44  
Yes     37     33     70  
Qualified for Medicaid  
[units: participants]
     
No     40     35     75  
Yes     17     22     39  
Pupil Diameter - Cataractous Eye  
[units: mm]
Mean (Standard Deviation)
  3.3  (1.0)     3.2  (1.0)     3.3  (1.0)  
Pupil Diameter - Fellow Eye  
[units: mm]
Mean (Standard Deviation)
  3.5  (0.9)     3.4  (0.9)     3.4  (0.9)  
Corneal Diameter - Cataractous Eye  
[units: mm]
Mean (Standard Deviation)
  10.5  (0.7)     10.5  (0.8)     10.5  (0.7)  
Corneal Diameter - Fellow Eye  
[units: mm]
Mean (Standard Deviation)
  10.8  (0.6)     10.8  (0.7)     10.8  (0.6)  
Intraocular Pressure - Cataractous Eye  
[units: mmHg]
Mean (Standard Deviation)
  12.7  (4.9)     11.8  (4.9)     12.2  (4.9)  
Intraocular Pressure - Fellow Eye  
[units: mmHg]
Mean (Standard Deviation)
  12.8  (5.1)     12.9  (4.3)     12.9  (4.7)  
Keratometric Power - Cataractous Eye  
[units: diopters]
Mean (Standard Deviation)
  46.4  (2.7)     46.4  (2.7)     46.4  (2.7)  
Keratometric Power - Fellow Eye  
[units: diopters]
Mean (Standard Deviation)
  45.5  (1.8)     45.4  (1.9)     45.5  (1.8)  
Axial Length - Cataractous Eye  
[units: mm]
Mean (Standard Deviation)
  18.0  (1.3)     18.1  (1.3)     18.0  (1.3)  
Axial Length - Fellow Eye  
[units: mm]
Mean (Standard Deviation)
  18.4  (0.9)     18.7  (0.9)     18.6  (0.9)  
Refractive Error - Fellow Eye [1]
[units: diopters]
Mean (Standard Deviation)
  2.4  (1.8)     2.3  (2.2)     2.3  (2.0)  
[1] Spherical equivalent of the refraction measured under cycloplegia



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Visual Acuity   [ Time Frame: Phase 1 - Age 12 months ]

2.  Primary:   Visual Acuity - Subjective Assessment at Age 4.5 Years.   [ Time Frame: Phase 2 - Age 4.5 Years ]

3.  Secondary:   Percent of Patients With 1 or More Intraoperative Complications at Cataract Surgery   [ Time Frame: Cataract surgery immediately after enrollment ]

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

5.  Secondary:   Parenting Stress   [ Time Frame: Phase 1 - 3 months post surgery ]

6.  Secondary:   Adherence to Occlusion Therapy   [ Time Frame: Phase 1 - 12 months follow-up ]

7.  Secondary:   Parenting Stress   [ Time Frame: Phase 1 - Age 12 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Scott R Lambert, MD, Study Chairman
Organization: Emory School of Medicine
phone: 404-778-3709
e-mail: slamber@emory.edu


No publications provided by Emory University

Publications automatically indexed to this study:


Responsible Party: Scott R Lambert, MD, Emory University
ClinicalTrials.gov Identifier: NCT00212134     History of Changes
Other Study ID Numbers: IRB00024837, U10EY013272, EY013287, EY013272, NEI-108
Study First Received: September 13, 2005
Results First Received: July 15, 2013
Last Updated: February 6, 2015
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Data and Safety Monitoring Board