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Evaluation of Ocular Lens Proteins in Cataract From Individuals With Down Syndrome

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: NCT03778528
Recruitment Status : Terminated (researcher left the institution study will not continue)
First Posted : December 19, 2018
Last Update Posted : July 7, 2020
Children's Hospital Colorado
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
This study involves the collection ocular lens tissue from individuals with Down syndrome and age-matched controls at the time of cataract surgery.

Condition or disease Intervention/treatment
Cataract Down Syndrome Procedure: cataract surgery

Detailed Description:
Individuals with Down syndrome have an increased rate of cataract. The reason for this increase is unclear. Normally, once cataracts become a significant impairment, an ophthalmologist will determine when cataract surgery should be performed. When this surgery is performed, cataractous tissues are cut out and discarded with medical waste. In this study, these tissue will be collected and protein analysis performed to determine what changes in different proteins are found in Down syndrome lenses as compared to normal cataractous lenses.

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Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Ocular Lens Proteins in Cataract From Individuals With Down Syndrome
Actual Study Start Date : May 30, 2018
Actual Primary Completion Date : July 1, 2020
Actual Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Down syndrome
Individuals with Down syndrome undergoing cataract surgery.
Procedure: cataract surgery
tissue collection.

Age-matched controls undergoing cataract surgery.
Procedure: cataract surgery
tissue collection.

Primary Outcome Measures :
  1. Change in protein composition [ Time Frame: one week after collection of tissue ]
    western blot analysis of proteins from cataractous tissue

Biospecimen Retention:   Samples With DNA
cataractous tissue removed at time of cataract surgery

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.

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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals with Down syndrome having cataract surgery or age-matched control.

Inclusion Criteria:

  • Undergoing cataract surgery for lens extraction.

Exclusion Criteria:

  • Known genetic cause other than Down syndrome causing cataract.

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): NCT03778528

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United States, Colorado
Children's Hospital of Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Children's Hospital Colorado
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Responsible Party: University of Colorado, Denver Identifier: NCT03778528    
Other Study ID Numbers: 17-0372
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Age, trisomy status, protein concentration levels

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Down Syndrome
Pathologic Processes
Lens Diseases
Eye Diseases
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn