Comparing two OCT imaging systems for pediatric retina evaluation
Optimize Pediatric OCT (Optical Coherence Tomography) Imaging: a Pilot Study
Duke University · NCT06139523
This study is testing two different eye imaging systems to see which one works better for looking at the retinas of children.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Sex | All |
| Sponsor | Duke University (other) |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06139523 on ClinicalTrials.gov |
What this trial studies
This observational pilot study aims to compare a new contact optical coherence tomography (OCT) system with an investigational noncontact OCT system to evaluate their effectiveness in imaging the pediatric retina. The study will enroll 10 healthy adult volunteers and 20 pediatric patients, assessing the contact system's ability to capture larger areas of the retina while maintaining similar image quality. Imaging data will be processed and analyzed at the Duke Advanced Research in SD/SSOCT Imaging Laboratory, with a focus on ensuring safety and minimizing risks associated with the imaging procedures.
Who should consider this trial
Good fit: Ideal candidates include pediatric patients under 18 years of age who are undergoing examination at the Duke Eye Center.
Not a fit: Patients with significant ocular issues or those unable to consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy and effectiveness of retinal imaging in pediatric patients, leading to better diagnosis and management of retinal diseases.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving imaging techniques for retinal evaluation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * Students or employees under direct supervision of the investigators * Subjects with prior problems with pupil dilation * Pregnant woman if receiving dilating drops * Group 2 - Pediatric participants * 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 this trial is running
Durham, North Carolina
- Duke University Eye Center — Durham, North Carolina, United States (RECRUITING)
Study contacts
- Study coordinator: Xi Chen, MD
- Email: xi2.chen@duke.edu
- Phone: (919)684-8434
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Retinal Disease, Glaucoma, Optic Nerve Diseases, Optical Coherence Tomography