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TerminatedNCT03778528Updated Jul 7, 2020

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

An observational study in Cataract and Down Syndrome, sponsored by University of Colorado, Denver. Terminated at 1 site in United States. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2020-07-07.

Sponsored by University of Colorado, Denver · Observational

Why this study was terminated
researcher left the institution study will not continue
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1
Ages
1 Month to 18 Years
Sex
All
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Study summary

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

Read the 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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Conditions studied

  • Cataract
  • Down Syndrome
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In context

Down Syndrome

432 studies on the registry are indexed under Down Syndrome; 100 are open to participants now.

This study's enrollment of 1 is below the median of 150 across 141 observational studies indexed under Down Syndrome.

Browse Down Syndrome studies →

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Month to 18 Years
Sexes eligible
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

Exclusion Criteria:

  • Known genetic cause other than Down syndrome causing cataract.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1 participant (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Down syndrome

    Individuals with Down syndrome undergoing cataract surgery.

    Procedure: cataract surgery

  • Control

    Age-matched controls undergoing cataract surgery.

    Procedure: cataract surgery

Interventions

  • Procedurecataract surgery

    tissue collection.

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What researchers measure

Primary outcomes

  1. Change in protein composition

    western blot analysis of proteins from cataractous tissue

    Time frame: one week after collection of tissue

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Study locations

1 site
  • Children's Hospital of Colorado
    Aurora, Colorado 80045, United States
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References and documents

Individual participant data

Plan to share: No — Age, trisomy status, protein concentration levels

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03778528
Lead sponsor
University of Colorado, Denver
Collaborators
Children's Hospital Colorado
Responsible party
Sponsor
First posted
Dec 19, 2018
Start date
May 30, 2018
Primary completion
Jul 1, 2020
Completion
Jul 1, 2020
Last update
Jul 7, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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