Evaluation of Ocular Lens Proteins in Cataract From Indiv... | NCT03778528

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

NCT03778528

Sponsor

University of Colorado, Denver

Status

Terminated

Last Update Posted

Jul 7, 2020Actual

Enrollment

1Actual

Phase

Not provided

Conditions

Cataract
Down Syndrome

Interventions

cataract surgery

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

researcher left the institution study will not continue

Expanded Access Info

Start Date

May 30, 2018Actual

Primary Completion Date

Jul 1, 2020Actual

Completion Date

Jul 1, 2020Actual

First Submitted Date

Dec 12, 2018

First Submission Date that Met QC Criteria

Dec 14, 2018

First Posted Date

Dec 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2020

Last Update Posted Date

Jul 7, 2020Actual

Name	Class
Children's Hospital Colorado	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Down syndrome		Individuals with Down syndrome undergoing cataract surgery.	Procedure: cataract surgery
Control		Age-matched controls undergoing cataract surgery.	Procedure: cataract surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cataract surgery	Procedure	tissue collection.	Control Down syndrome

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in protein composition	western blot analysis of proteins from cataractous tissue	one week after collection of tissue

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Undergoing cataract surgery for lens extraction.

Exclusion Criteria:

Known genetic cause other than Down syndrome causing cataract.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Individuals with Down syndrome having cataract surgery or age-matched control.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital of Colorado		Aurora	Colorado	80045	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Age, trisomy status, protein concentration levels

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract
D004314	Down Syndrome

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases
D008607	Intellectual Disability
D019954	Neurobehavioral Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002387	Cataract Extraction

Ancestor Terms

ID	Term
D054140	Refractive Surgical Procedures
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided