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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03778528
Other study ID # 17-0372
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date May 30, 2018
Est. completion date July 1, 2020

Study information

Verified date July 2020
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date July 1, 2020
Est. primary completion date July 1, 2020
Accepts healthy volunteers No
Gender All
Age group 1 Month to 18 Years
Eligibility Inclusion Criteria:

- Undergoing cataract surgery for lens extraction.

Exclusion Criteria:

- Known genetic cause other than Down syndrome causing cataract.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
cataract surgery
tissue collection.

Locations

Country Name City State
United States Children's Hospital of Colorado Aurora Colorado

Sponsors (2)

Lead Sponsor Collaborator
University of Colorado, Denver Children's Hospital Colorado

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in protein composition western blot analysis of proteins from cataractous tissue one week after collection of tissue
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