Optimize Pediatric OCT Imaging
Handheld optical coherence tomography (OCT) has become an important imaging modality to evaluate the pediatric retina. The objective of this pilot study is to compare a new contact OCT system (Theia Imaging) with an investigational noncontact OCT system (Duke Biomedical Engineering) to assess their ability to image the
| Condition(s) | Retinal Disease, Glaucoma, Optic Nerve Diseases |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | Handheld optical coherence tomography (OCT) has become an important imaging modality to evaluate the pediatric retina. The objective of this pilot study is to compare a new contact OCT system (Theia Imaging) with an investigational noncontact OCT system (Duke Biomedical Engineering) to assess their ability to image the pediatric retina. The investigators hypothesize that the contact OCT system is superior in imaging larger areas of the retina (larger field-of-view), while it has similar resolution to image the retina substructures (non-inferior image quality). |
| Who can participate | Inclusion Criteria: * Group 1 - Healthy adult volunteers * Subject is able and willing to consent to study participation * Subject is more than 18 years of age * Healthy adult volunteers without known ocular issues other than refractive error * Pregnancy Reasonably Excluded Guide (PREG) evaluation on women of childbearing potential * Group 2 - Pediatric participants * Health care provider, knowledgeable of protocol, agrees that study personnel could contact the parent/legal guardian * Parent/legal guardian is able and willing to consent to study participation * Pediatric patient less than 18 years of age in Duke Eye Center ophthalmology clinics or undergoing clinically-indicated examination under anesthesia at Duke Eye Center Exclusion Criteria: * Group 1 - Healthy adult volunteers * Stude |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Duke University |
| Locations | Durham, North Carolina, United States |
| Start date | 2024-01-24 |
| NCT ID | NCT06139523 |
| Official listing | https://clinicaltrials.gov/study/NCT06139523 |