Advancing Pediatric Retinal Imaging With Auto-aligned OCT
Recruiting · NCT06841575 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Auto-aligned OCT
What this trial is about
The goal of the current study is to conduct a pilot study to test a new version of the handheld OCT device capable of auto-alignment to image the retina in adult volunteers, and adult and pediatric patients in clinic.
Who can take part
Age range
1 Month and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
- Group 2: Adult patients in ophthalmology clinics
- Health care provider, knowledgeable of protocol, agrees that study personnel could contact the subject
- Subject is able and willing to consent to study participation
- Subject is more than 18 years of age and is a patient in the Duke Eye Center ophthalmology clinics
- Group 3: Pediatric participants in ophthalmology clinics
- 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
- Students or employees under direct supervision of the investigators
- Subjects with prior problems with pupil dilation
- Pregnant woman if receiving dilating drops
- Group 2: Adult patients in ophthalmology clinics
- Participant has a health or eye condition that preclude eye examination or retinal imaging (such as corneal opacity or cataract)
- Group 3: Pediatric participants in ophthalmology clinics
- Parent/legal guardian unwilling or unable to provide consent
- Participant has a health or eye condition that preclude eye examination or retinal imaging (such as corneal opacity or cataract)
Where it is running
1 location listed across 1 US state.
- Duke University Eye Center - Durham, North Carolina, United States