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

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ClinicalTrials.gov Identifier: NCT03778528
Recruitment Status : Recruiting
First Posted : December 18, 2018
Last Update Posted : December 18, 2018
Sponsor:
Collaborator:
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
Estimated Enrollment : 20 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
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : June 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.

Control
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

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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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03778528


Contacts
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Contact: Niklaus H Mueller 3037249995 niklaus.mueller@ucdenver.edu

Locations
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United States, Colorado
Children's Hospital of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Niklaus H Mueller    303-724-9995    niklaus.mueller@ucdenver.edu   
Sponsors and Collaborators
University of Colorado, Denver
Children's Hospital Colorado

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03778528     History of Changes
Other Study ID Numbers: 17-0372
First Posted: December 18, 2018    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018
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
Cataract
Syndrome
Disease
Pathologic Processes
Lens Diseases
Eye Diseases
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn