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Trial record 28 of 167 for:    trisomy21 NOT prenatal

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

Tracking Information
First Submitted Date December 12, 2018
First Posted Date December 18, 2018
Last Update Posted Date December 18, 2018
Actual Study Start Date May 30, 2018
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 14, 2018)
Change in protein composition [ Time Frame: one week after collection of tissue ]
western blot analysis of proteins from cataractous tissue
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Ocular Lens Proteins in Cataract From Individuals With Down Syndrome
Official Title Evaluation of Ocular Lens Proteins in Cataract From Individuals With Down Syndrome
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
cataractous tissue removed at time of cataract surgery
Sampling Method Non-Probability Sample
Study Population Individuals with Down syndrome having cataract surgery or age-matched control.
Condition
  • Cataract
  • Down Syndrome
Intervention Procedure: cataract surgery
tissue collection.
Study Groups/Cohorts
  • Down syndrome
    Individuals with Down syndrome undergoing cataract surgery.
    Intervention: Procedure: cataract surgery
  • Control
    Age-matched controls undergoing cataract surgery.
    Intervention: Procedure: cataract surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 14, 2018)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Undergoing cataract surgery for lens extraction.

Exclusion Criteria:

  • Known genetic cause other than Down syndrome causing cataract.
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Month to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Niklaus H Mueller 3037249995 niklaus.mueller@ucdenver.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03778528
Other Study ID Numbers 17-0372
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Age, trisomy status, protein concentration levels
Responsible Party University of Colorado, Denver
Study Sponsor University of Colorado, Denver
Collaborators Children's Hospital Colorado
Investigators Not Provided
PRS Account University of Colorado, Denver
Verification Date December 2018