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Search / Trial NCT06139523

Optimize Pediatric OCT Imaging

Launched by DUKE UNIVERSITY · Nov 15, 2023

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Optical Coherence Tomography (Oct)

ClinConnect Summary

This clinical trial, called "Optimize Pediatric OCT Imaging," is trying to find out which of two new imaging systems can better capture pictures of the retina in children. The retina is the part of the eye that helps us see, and this study is comparing a contact system, which touches the eye, with a non-contact system, which does not. Researchers believe that the contact system will cover more area of the retina while still providing clear images, similar to the non-contact system.

To participate, adults must be healthy and over 18, while pediatric participants need to be under 18 and receiving eye care at the Duke Eye Center. Parents or guardians must be willing to give consent for their child to join. Participants can expect to have their eyes imaged using these advanced systems, helping researchers understand how to better assess eye health in young patients. It’s important to note that individuals with specific eye conditions or health issues may not be eligible for the study.

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
  • 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)

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

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported