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NCT03845218 · ClinicalTrials.gov registry record
Retinitis Pigmentosa Clinical Measures and Repeatability Testing of Potential Outcome Measures
A clinical trial, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- 49
- Enrollment target
NCT03845218: Completed study, sponsored by National Eye Institute (NEI).
NCT03845218 is a clinical trial that has completed, run by National Eye Institute (NEI). The registered enrollment target is 49 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03845218 has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- 49 participants
- Enrollment target
Study Summary
Background: Retinitis pigmentosa (RP) is a group of blinding eye diseases. It is caused mostly by mutations in photoreceptor-expressed genes. RP affects about 2 million people globally. There is no cure, but treatment and diagnosis can be guided by certain tests. Researchers want to see how well these tests capture stages of RP. Objectives: To find out how well certain tests track changes in retinitis pigmentosa. Eligibility: People ages 12 and older with RP Healthy volunteers ages 18 and older with no evidence of RP Design: Participants will be screened in another protocol. Participants will have 2 visits about 6 weeks apart. Both will include all the tests below. Each visit will last 5-6 hours, or a visit can be split into 2 days. Participants will give their medical and eye history. Participants will have an eye exam. Their pupils will be dilated with eye drops. Participants will give blood samples. Pictures of participants retinas will be taken. Their retinas will be measured. Participants will take several eye tests. They will: Sit in a dark room and press a button when they see lights. View a bright background then press a button when they see lights. Look into a bowl and press a button when they see lights. Sit in the dark with their eyes patched. Then they will take eye-numbing drops and wear contacts as lights flash. A small electrode taped to their forehead will record signals from their retinas. Minors will give written consent to stay in the study when they turn 18. After the study ends, they may also be asked to give consent for researchers to continue to use their study information.
Primary Outcome
The primary outcome measure will be the limits of agreement in repeatability calculations of the tests performed.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2019-09-27 |
| Est. Completion | 2023-07-19 |
What the finished NCT03845218 record still lists
NCT03845218 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 49 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT03845218 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03845218 about?
NCT03845218 is a clinical study titled "Retinitis Pigmentosa Clinical Measures and Repeatability Testing of Potential Outcome Measures". Background: Retinitis pigmentosa (RP) is a group of blinding eye diseases. It is caused mostly by mutations in photoreceptor-expressed genes. RP affects about 2 million people globally. There is no cure, but treatment and diagnosis can be guided by certain tests. Researchers want to see how well th...
What is the current status of trial NCT03845218?
This trial is currently completed. The enrollment target is 49 participants. The study started on 2019-09-27. Estimated completion is 2023-07-19.
Who is sponsoring clinical trial NCT03845218?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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