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NCT02117323 · ClinicalTrials.gov registry record
Corneal Opacities in Children
A clinical trial, sponsored by Oregon Health and Science University.
- Completed
- Registry status
- 54
- Enrollment target
NCT02117323: Completed study, sponsored by Oregon Health and Science University.
NCT02117323 is a clinical trial that has completed, run by Oregon Health and Science University. The registered enrollment target is 54 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02117323 has completed, sponsored by Oregon Health and Science University.
- COMPLETED
- Registry status
- 54 participants
- Enrollment target
Study Summary
A prospective observational study on corneal opacities in infants and children (1 month to 18 years old) will be conducted at CHLA. Most of these cases will be due to congenital corneal opacity (e.g. Peter's anomaly, mucopolysacharidoses) or scarring due to infectious keratitis. Sixty (60) subjects will be recruited. The children will be examined under anesthesia with a portable slit-lamp and OCT. An iVue OCT system (Optovue) attached to an operating microscope-style mount at CHLA will be used for the intraoperative scans. Both cross-sectional and 3-D OCT scans will be performed to assess opacity depth, pachymetry map, endothelial defects, and any abnormal adhesion between the cornea, iris and lens. The anterior chamber angle will also be imaged with cross-sectional OCT to assess angle depth, trabecular meshwork, Schwalbe's line, and possible peripheral iridocorneal adhesion or posterior embryotoxon. OCT of the crystalline lens will be obtained to assess the presence of cataract. Slit-lamp photography will be obtained, and gonioscopy will be performed if indicated. Corneal diameter will be measured with a caliper, and intraocular pressure will be measured with a tonopen (Reichert).
Primary Outcome
The primary goal of the study will be to identify subjects suitable for the trial with OCT-guided LALAK. The determination will be based on analysis of clinical history \& OCT corneal images as well as the subjects' willingness to participate in the study.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2011-09 |
| Est. Completion | 2016-08-31 |
What the finished NCT02117323 record still lists
NCT02117323 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 54 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02117323 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02117323 about?
NCT02117323 is a clinical study titled "Corneal Opacities in Children". A prospective observational study on corneal opacities in infants and children (1 month to 18 years old) will be conducted at CHLA. Most of these cases will be due to congenital corneal opacity (e.g. Peter's anomaly, mucopolysacharidoses) or scarring due to infectious keratitis. Sixty (60) subjects ...
What is the current status of trial NCT02117323?
This trial is currently completed. The enrollment target is 54 participants. The study started on 2011-09. Estimated completion is 2016-08-31.
Who is sponsoring clinical trial NCT02117323?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
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