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NCT04833361 · ClinicalTrials.gov registry record
Potential Environmental Causes of Uveal Coloboma
A clinical trial of Coloboma, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- 76
- Enrollment target
- 1
- Study location
NCT04833361: Completed study of Coloboma, sponsored by National Eye Institute (NEI).
NCT04833361 is a study of Coloboma that has completed, run by National Eye Institute (NEI). The registered enrollment target is 76 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04833361, a study of Coloboma, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- 76 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Uveal coloboma is a congenital eye malformation. It is thought to be a genetic condition. But it might have environmental causes as well. Researchers want to study the mothers of children with coloboma. They will use parts of the National Birth Defects Prevention Study (NBDPS) Mother Questionnaire. NBDPS was a large study of birth defects. It collected data from 1997 to 2011. Researchers will use NBDPS and NIH data as well as the new survey to produce data that can serve as a basis for further study. Objective: To explore maternal factors and exposures during the first trimester of pregnancy as potential causes of uveal coloboma and to correlate exposure data to clinical data from affected children. Eligibility: Mothers of probands with coloboma who have taken part in NIH study 06-EI-0230, 04-EI-0039, or 13-EI-0049. Design: This is a hybrid study. It will use existing data from NBDPS and NIH studies. It will also use NBDPS for a new survey of mothers of children with coloboma. Participants will take the survey by phone. Their pregnancy records may be reviewed. They will be asked about: Important dates Health and medicines Tobacco, alcohol, and substance use Parents occupations Family demographics. The survey will take 1 hour or less to complete. Some data were obtained in past NIH studies. These data are largely from children. Some family data may be used as well. For example, eye exam data, gene test results, and family history of coloboma may be used. If a participant did not consent to the future use of their data, then their data will not be used. Data will be stored in a secure NIH database. ...
Primary Outcome
% of participants with x exposure compared to historical data from NBDPS study.
Conditions Studied
Study Locations (1)
Maryland
- National Eye Institute (NEI) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2023-06-20 |
| Est. Completion | 2025-03-17 |
What the finished NCT04833361 record still lists
NCT04833361 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 76 participants, a relatively small participant target.
The record links to 1 condition, with Coloboma appearing as the primary indexed condition, and to 0 interventions.
NCT04833361 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04833361 about?
NCT04833361 is a clinical study titled "Potential Environmental Causes of Uveal Coloboma". Background: Uveal coloboma is a congenital eye malformation. It is thought to be a genetic condition. But it might have environmental causes as well. Researchers want to study the mothers of children with coloboma. They will use parts of the National Birth Defects Prevention Study (NBDPS) Mother Qu...
What is the current status of trial NCT04833361?
This trial is currently completed. The enrollment target is 76 participants. The study started on 2023-06-20. Estimated completion is 2025-03-17.
What conditions does trial NCT04833361 study?
This clinical trial studies the following conditions: Coloboma.
Who is sponsoring clinical trial NCT04833361?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04833361 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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