ClinConnect ClinConnect Logo
Search / Trial NCT06841575

Advancing Pediatric Retinal Imaging With Auto-aligned OCT

Launched by DUKE UNIVERSITY · Feb 19, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Optical Coherence Tomography (Oct)

ClinConnect Summary

This clinical trial is testing a new handheld device that can take pictures of the retina, which is the light-sensitive layer at the back of the eye. The device has a special feature that helps it automatically align itself, making it easier to get clear images. The goal is to see how well this device works in both adults and children who visit eye clinics, especially for those with eye diseases like glaucoma or other optic nerve conditions.

To participate, you need to be at least 18 years old and either a healthy adult or a patient at the Duke Eye Center. For children, a parent or legal guardian must agree to take part in the study. Participants will have their eyes examined using this new imaging device, which is safe and aims to improve how we diagnose and treat eye conditions. The trial is not currently recruiting participants, but it will be open to individuals of all genders who meet the eligibility criteria.

Gender

ALL

Eligibility 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
  • 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)

About Duke University

Duke University, a leading academic and research institution located in Durham, North Carolina, is renowned for its commitment to advancing healthcare through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, Duke conducts a wide array of clinical trials aimed at developing cutting-edge therapies and improving patient outcomes across various medical fields. The university's Clinical Research Institute provides comprehensive support for trial design, implementation, and regulatory compliance, ensuring that all research adheres to the highest ethical and scientific standards. Duke’s dedication to translating research findings into effective clinical practices underscores its role as a pivotal contributor to the global medical community.

Locations

Durham, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Xi Chen, MD, PhD

Principal Investigator

Duke University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported