No Eye Disease Clinical Trial
Official title:
Optical Coherence Tomography Data Collection Study
| Verified date | May 2012 |
| Source | Optovue |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
Collect OCT data to evaluate the range and age trend of eye measurements.
| Status | Completed |
| Enrollment | 400 |
| Est. completion date | March 2012 |
| Est. primary completion date | March 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - At least 18 years of age - Able and willing to provide consent - Able and willing to complete the required examininations and visit - Refractive error within 8 diopters sphere and within 2 diopters cylinder in each eye - Best corrected visual acuity of 20/30 or better in each eye Exclusion Criteria: - History of leukemia, AIDS, dementia or multiple sclerosis - Concomitant use of hydroxycloroquine or chloroquine - Family history of glaucoma among first degree relatives - Intraocular pressure of 22mm Hg or greater in either eye - Unreliable or abnormal visual field - Active ocular disease - Previously diagnosed with glaucoma or glaucoma suspect - Congenital ocular abnormalities - Previous intra-ocular surgery or laser treatment (other than refractive surgery or uncomplicated cataract surgery greater than 6 months previously) - Anatomic narrow angle |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Institute of Ophthalmology, University College London | London | England |
| United States | Illinois Eye Institute | Chicago | Illinois |
| United States | Southern California College of Optometry | Fullerton | California |
| United States | College of Optometry, Western University of Health Sciences | Pomona | California |
| United States | Buena Vista Eye Care | San Jose | California |
| Lead Sponsor | Collaborator |
|---|---|
| Optovue |
United States, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | range of eye measurements | Day 1 | No | |
| Secondary | age trend of eye measurements | Day 1 | No |