Corneal Opacities Clinical Trial
— OCTOfficial title:
Observational Study on Corneal Opacities in Children
| Verified date | April 2018 |
| Source | Oregon Health and Science University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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).
| Status | Completed |
| Enrollment | 54 |
| Est. completion date | August 31, 2016 |
| Est. primary completion date | August 31, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 1 Month to 18 Years |
| Eligibility |
Inclusion Criteria: - Infants and children (1 month to 18 years of age) with corneal opacity requiring a thorough eye examination. Exclusion Criteria: - Inability to give informed consent. - Inability to maintain stable fixation for OCT imaging. - Inability to commit to required visits to complete the study. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Children's Hospital Los Angeles | Los Angeles | California |
| Lead Sponsor | Collaborator |
|---|---|
| Oregon Health and Science University | National Eye Institute (NEI), National Institutes of Health (NIH) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of suitable subjects | 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. | 5 years |