CataractNCT03778528
Evaluation of Ocular Lens Proteins in Cataract From Individuals With Down Syndrome
An observational study of Cataract and Down Syndrome, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Cataract, Down Syndrome
- What is being tested?
- cataract surgery
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2018to 1 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Individuals with Down syndrome having cataract surgery or age-matched control.
Who may be able to join
- Undergoing cataract surgery for lens extraction.
Who cannot join
- Known genetic cause other than Down syndrome causing cataract.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Colorado
Aurora, Colorado, 80045
About this study
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.
- Conditions
- Cataract, Down Syndrome
- Being tested
- cataract surgery
- Medical subject headings
- Cataract, Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cataract surgeryProcedure or surgery
tissue collection.
| Study group | Role | What they receive |
|---|---|---|
| Down syndrome | Individuals with Down syndrome undergoing cataract surgery. Receives: Procedure: cataract surgery | |
| Control | Age-matched controls undergoing cataract surgery. Receives: Procedure: cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in protein composition
western blot analysis of proteins from cataractous tissue
Measured: one week after collection of tissue
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start30 May 2018
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Why it stopped: researcher left the institution study will not continue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Colorado
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778528
- Sponsor's protocol ID
- 17-0372
- Status last verified
- Jul 2020
- First submitted
- 12 Dec 2018
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Age, trisomy status, protein concentration levels
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ocular Lens Proteins in Cataract From Individuals With Down Syndrome
- ClinicalTrials.gov ID
- NCT03778528
- Acronym / sponsor ID
- 17-0372
- Conditions
- Cataract, Down Syndrome
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: researcher left the institution study will not continue
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Children's Hospital Colorado
- Study start
- 30 May 2018 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Down syndrome | – | Procedure: cataract surgeryIndividuals with Down syndrome undergoing cataract surgery. |
| Control | – | Procedure: cataract surgeryAge-matched controls undergoing cataract surgery. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Individuals with Down syndrome having cataract surgery or age-matched control.
Key inclusion criteria (1 listed)
- Undergoing cataract surgery for lens extraction.
Key exclusion criteria (1 listed)
- Known genetic cause other than Down syndrome causing cataract.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cataract surgerytissue collection. | Procedure or surgery | Control, Down syndrome |
Primary outcome
Change in protein composition
Time frame: one week after collection of tissue
western blot analysis of proteins from cataractous tissue
Results and safety
The study was stopped early (reason given: researcher left the institution study will not continue). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Individual participant dataSharing planned: No. Age, trisomy status, protein concentration levels
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Down Syndrome, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: researcher left the institution study will not continue). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in protein composition (time frame: one week after collection of tissue). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.