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Infant Aphakia Treatment Study (IATS) (IATS)

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ClinicalTrials.gov Identifier: NCT00212134
Recruitment Status : Active, not recruiting
First Posted : September 21, 2005
Results First Posted : January 5, 2015
Last Update Posted : March 9, 2018
Sponsor:
Collaborators:
National Eye Institute (NEI)
Alcon Research
Bausch & Lomb Incorporated
BSN-JOBST Inc.
Eye Care and Cure
Information provided by (Responsible Party):
Scott Reed Lambert, Stanford University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Congenital Cataract
Interventions: Device: Contact lens correction of aphakia
Device: Intraocular lens implantation

  Participant Flow

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 3 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.

Period 3:   Phase 3 (Age 10 Years)
    Aphakic Contact Lens   Aphakic Intraocular Lens
STARTED   57   56 
COMPLETED   36   35 
NOT COMPLETED   21   21 
On Going                21                21 



  Baseline Characteristics

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 
Overall Participants Analyzed 
[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 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      32  56.1%      28  49.1%      60  52.6% 
Male      25  43.9%      29  50.9%      54  47.4% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      9  15.8%      10  17.5%      19  16.7% 
Not Hispanic or Latino      48  84.2%      47  82.5%      95  83.3% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      1   1.8%      0   0.0%      1   0.9% 
Asian      2   3.5%      1   1.8%      3   2.6% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      3   5.3%      5   8.8%      8   7.0% 
White      49  86.0%      48  84.2%      97  85.1% 
More than one race      0   0.0%      3   5.3%      3   2.6% 
Unknown or Not Reported      2   3.5%      0   0.0%      2   1.8% 
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

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 ]

8.  Primary:   Visual Acuity - Subjective Assessment at Age 10 Years.   [ Time Frame: Phase 3 Age 10 Years ]
Results not yet reported.   Anticipated Reporting Date:   03/2019  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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: Stanford University School of Medicine
phone: 650-498-4242
e-mail: lambert7@stanford.edu


Publications:

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

Responsible Party: Scott Reed Lambert, Stanford University
ClinicalTrials.gov Identifier: NCT00212134     History of Changes
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 Submitted: September 13, 2005
First Posted: September 21, 2005
Results First Submitted: July 15, 2013
Results First Posted: January 5, 2015
Last Update Posted: March 9, 2018